Trigriluzole Fast Tracked for Rare Neurodegenerative Disorder

By May 15, 2017

The FDA has granted Fast Track designation to trigriluzole (BHV-4157; Biohaven) for the potential treatment of Spinocerebellar Ataxia (SCA), a rare and debilitating neurodegenerative disorder.

Tenapanor Achieves Primary Endpoint in IBS-C Trial

By May 12, 2017

Results showed that the endpoint was met with 27% in the tenapanor arm compared to 18.7% in the placebo arm (P=0.02) having at least 30% reduction in abdominal pain and an increase of 1 or more complete spontaneous bowel movements.

Novel Treatment for IgG4-Related Disease Gains Orphan Drug Status

By May 12, 2017

There is currently no approved treatment for lgG4-RD, which is a newly recognized disorder and is estimated to affect 40,000 individuals in the U.S.

Once-Monthly Biologic Looks Promising for Migraine Prophylaxis

By May 12, 2017

Lilly announced encouraging results from three Phase 3 studies of galcanezumab, EVOLVE-1, EVOLVE-2 and REGAIN, evaluating its efficacy and safety for the prevention of episodic and chronic migraine.

First-in-Class Oral Enzyme Designated Breakthrough Therapy for CDI Prevention

By May 11, 2017

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for ribaxamase (SYN-004; Synthetic Biologics) for the prevention of Clostridium difficile infection (CDI).

Gimoti Shows Benefit in Moderate to Severe Diabetic Gastroparesis

By May 11, 2017

Results showed that the primary efficacy endpoint of change from baseline to week 4 was not statistically met (P=0.881), although a significant treatment benefit was seen in patients with moderate to severe symptoms (P<0.05).

FDA Grants Vonapanitase Breakthrough Therapy Status for Hemodialysis Use

By May 10, 2017

A second Phase 3 trial for vonapanitase in hemodialysis patients, PATENCY-2, is currently ongoing and is expected to complete enrollment in the first quarter of 2018.

FDA Issues Complete Response Letter for Dyspareunia Drug

By May 09, 2017

The FDA has issued a Complete Response Letter (CRL) to the New Drug Application (NDA) of TX-004HR (TherapeuticsMD) for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA) due to menopause.

FDA Fast Tracks Gene Therapy for Chronic Angina Patients

By May 08, 2017

XC001 is an investigational cardiovascular angiogenic gene therapy that promotes angiogenesis to provide arterial blood flow to myocardial regions with inadequate blood supply.

Xeljanz Under FDA Review for Psoriatic Arthritis

By May 05, 2017

An anticipated Prescription Drug User Fee Act (PDUFA) action date of December 2017 has been set by the FDA for both Xeljanz sNDAs.

Brexpiprazole Evaluated for Agitation in Alzheimer's Dementia

May 03, 2017

Otsuka and Lundbeck announced top-line results from two Phase 3 trials of brexpiprazole for the treatment of agitation in patients with dementia of the Alzheimer's type.

Xarelto sNDA Looks to Add New Dosing Option to Reduce Recurrent VTE Risk

By May 02, 2017

The new sNDA submission is supported by the 'Einstein Choice' study, which included 3,365 patients in a Phase 3 randomized, double-blind study that compared Xarelto once daily to aspirin.

Intranasal Midazolam Evaluated as Rescue Therapy for Seizure Clusters

By May 02, 2017

Proximagen announced promising data from the pivotal Phase 3 trial of USL261 (intranasal midazolam) for the rescue treatment of seizure clusters. The primary efficacy endpoint was treatment success, defined as achieving 1) termination of seizure(s) and 2) no recurrence of seizure(s)

FDA Grants Lorlatinib Breakthrough Therapy Designation for NSCLC

By April 28, 2017

Pfizer has begun enrolling patients in a Phase 3 study of lorlatinib, called 'CROWN'. The trial will be an open-label randomized, two-arm study comparing lorlatinib to crizotinib in the first-line treatment of patients with metastatic ALK-positive NSCLC.

FDA to Review BLA Resubmission of Rheumatoid Arthritis Biologic

By April 28, 2017

The FDA has accepted for review the resubmission of the Biologics License Application (BLA) for Kevzara (sarilumab; Regeneron and Sanofi) for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease modifying antirheumatic drugs.

Novel DNRI Agent Improves ADHD Symptoms in Study

By April 21, 2017

Study data revealed children taking dasotraline 4mg daily had statistically significant and clinically meaningful improvement vs. placebo on the primary endpoint.

New Findings for Novel Pan-Genotypic HCV Regimen in Phase 3 Study

By April 20, 2017

New findings from EXPEDITION-1 showed that 99% of HCV infected patients with GT 1, 2, 4, 5 or 6 and compensated cirrhosis achieved SVR12 after 12 weeks of G/P treatment.

Tissue-Based Tx Granted Breakthrough Status for Complete DiGeorge Syndrome

By April 19, 2017

The FDA has granted Breakthrough Therapy and Regenerative Medicine Advanced Therapy (RMAT) designations for the investigational tissue-based therapy, RVT-802 (Enzyvant), for the treatment of complete DiGeorge Syndrome (cDGS).

FDA to Review Fostamatinib for Chronic, Persistent ITP

By April 18, 2017

Rigel announced its submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) for fostamatinib for the treatment of patients with chronic and persistent immune thrombocytopenic purpura (ITP).

Emicizumab Evaluated in Children with Hemophilia A

By April 17, 2017

The interim results from HAVEN 2, after a median of 12 weeks of treatment, showed that prophylaxis with emicizumab is associated with clinically meaningful reduction in the number of bleeds over time.

FDA Requires More Data Before Baricitinib Approval

By April 14, 2017

The NDA for baricitinib was submitted in January 2016 and a 3-month extension for time to review additional analyses was announced in January 2017.

NDA Submitted for Post-Cataract Surgery Inflammation Treatment

By April 13, 2017

Dexycu is a long-acting, biodegradable extended-release formulation of the anti-inflammatory agent dexamethasone, which is injected into the anterior chamber of the eye following cataract surgery.

FDA Fast Tracks d-Methadone as Adjunct Treatment for Depression

By April 13, 2017

The company has completed a Phase 1 study for REL-1017 and intends to initiate a randomized, double-blind, placebo-controlled Phase 2a trial in patients with major depressive disorder to assess its efficacy, safety, tolerability and pharmacokinetics.

Combo Tx Significantly Improves Lung Function in Cystic Fibrosis Study

By April 11, 2017

Results showed that the ivacaftor/tezacaftor group reached the primary endpoint with a mean absolute improvement in ppFEV1 of 4% points from baseline vs. placebo (P<0.0001).

Alectinib Improves Progression-Free Survival in NSCLC Study

April 10, 2017

The ALEX study is intended to convert Alecensa to full approval as an initial treatment.

Evinacumab Gets Breakthrough Status for Severe Form of Hypercholesterolemia

By April 06, 2017

Regeneron previously reported positive interim Phase 2 results which showed that evinacumab added to current lipid-lowering therapy reduced low-density lipoprotein cholesterol (LDL-C) levels by an additional 55%.

Opdivo Granted Priority Review for Colorectal Cancer Indication

By April 06, 2017

Opdivo, a human programmed death receptor-1 (PD-1)-blocking antibody, is already indicated for various renal and urologic cancers, head and neck cancer, lymphoma, skin cancer, and lung cancer.

First-in-Class Injectable Antibiotic Shows Promise for Complicated UTIs

By April 06, 2017

Zavante Therapeutics announced promising results from the pivotal ZEUS clinical trial, evaluating Zolyd (fosfomycin for injection) for the treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis (AP).

Imbruvica Under Review for Graft-Versus-Host-Disease

By April 05, 2017

Imbruvica is a first-in-class, oral Bruton's tyrosine kinase (BTK) inhibitor.

Amgen Looks to Expand Xgeva Use to Multiple Myeloma Patients

By April 05, 2017

The study met its primary endpoint of Xgeva non-inferiority versus zoledronic acid in delaying the time to first on-study SRE in multiple myeloma patients (HR=0.98, 95% CI: 0.85, 1.14; P=0.01).

Novel Tetracycline Goes Head-to-Head with Moxifloxacin in Pneumonia Study

By April 04, 2017

The study met the primary and secondary endpoints, showing that omadacycline is non-inferior to moxifloxacin for the treatment of CABP.

Bio-Identical Combo Therapy Promising for Vasomotor Symptoms of Menopause

By April 04, 2017

TherapeuticsMD announced positive data for its investigational hormone therapy, TX-001HR, for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. Study findings were presented at the annual meeting of the Endocrine Society, ENDO 2017.

FDA to Review Vyxeos for Acute Myeloid Leukemia

By April 03, 2017

Jazz Pharmaceuticals announced the completion of a rolling submission of the New Drug Application (NDA) for Vyxeos (cytarabine and daunorubicin) liposome to the Food and Drug Administration (FDA) for the treatment of acute myeloid leukemia (AML).

Coversin Gets Fast Track Status for Paroxysmal Nocturnal Hemoglobinuria

By March 31, 2017

Akari is currently investigating Coversin in two Phase 2 clinical trials in patients with paroxysmal nocturnal hemoglobinuria.

Blincyto Gains Priority Review for sBLA

By March 31, 2017

Blincyto is the first single-agent immunotherapy approved to treat patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

Novel Allergic Rhinitis Nasal Spray Shows Promise in Phase 3 Trial

By March 29, 2017

Results showed that GSP 301 was tied to statistically significant improvements from baseline for the primary endpoint when compared to placebo (P<0.001), olopatadine (P=0.028), and mometasone (P=0.019).

Synergy Seeks IBS-C Indication for Trulance

By March 28, 2017

The new application for an IBS-C indication is supported by data from two placebo-controlled Phase 3 studies that lasted 12 weeks and evaluated plecanatide in 2,100 patients with IBS-C.

Ryanodex Gets Priority Review for Exertional Heat Stroke

By March 27, 2017

The FDA has accepted and granted Priority Review to the New Drug Application (NDA) of Ryanodex (dantrolene sodium; Eagle) for the treatment of exertional heat stroke (EHS).

Sarecycline Promising for Moderate to Severe Acne

By March 27, 2017

Allergan and Paratek announced positive results from two Phase 3 studies of sarecycline for the treatment of moderate to severe acne.

Rituxan Gets Breakthrough Therapy Status for Rare Autoimmune Skin Disorder

By March 24, 2017

Genentech announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Rituxan (rituximab) for the treatment of pemphigus vulgaris.

Dravet Syndrome Tx Receives Orphan Drug Status

By March 23, 2017

Currently, FDA approved treatments for this disorder are unavailable in the U.S.

Single-Dose Treatment for Bacterial Vaginosis Under Priority Review

By March 23, 2017

The FDA has accepted and granted Priority Review to the New Drug Application (NDA) of Solosec (secnidazole oral granules; Symbiomix) for the treatment of bacterial vaginosis (BV).

FDA Fast Tracks Recombinant ADAMTS13 Enzyme Replacement Therapy

By March 22, 2017

Shire announced that the FDA has granted Fast Track designation to SHP655 (historically BAX930) for the treatment of acute episodes of hereditary thrombotic thrombocytopenic purpura (hTTP) in patients with a constitutional ADAMTS13 deficiency.

Orphan Drug Status Granted for C3 Glomerulopathy Treatment

By March 22, 2017

Patients with C3G experience progressive deterioration in renal function, ultimately leading to renal failure requiring dialysis and kidney transplant, if left untreated.

First-in-Class Opioid Analgesic Evaluated for Chronic Back Pain

By March 20, 2017

Nektar Therapeutics announced positive results from the SUMMIT-07 Phase 3 study of NKTR-181, a first-in-class opioid analgesic for the treatment of moderate to severe chronic pain.

Novel Drug Shows Promise for Excessive Sleepiness in OSA

By March 20, 2017

Both demonstrated highly statistically significant improvement in the co-primary endpoints of Maintenance of Wakefulness test and the Epworth Sleepiness scale, for JZP-110 versus placebo.

Sunovion Seeks Pediatric Indication for Aptiom

By March 13, 2017

Aptiom, a dibenzazepine carboxamide antiepileptic, is currently approved for use as monotherapy or adjunctive therapy for partial onset seizures (POS) in adults, the new supplemental NDA aims to extend this indication for the treatment of POS in children aged ≥4 years.

Evolocumab Reduces LDL-C Apheresis Need in Phase 3 Study

By March 13, 2017

Treatment with Repatha reached its primary endpoint of reducing the need for continued apheresis at the end of the randomization period.

FDA Grants Orphan Drug Status to MDS Biologic

By March 09, 2017

Boehringer Ingelheim announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to BI 836858 for the treatment of myelodysplastic syndromes (MDS).

Antibiotic Drug Reservoir Granted QIDP Status for Surgical Infections

By March 08, 2017

The FDA has granted Qualified Infectious Disease Product (QIDP) to D-PLEX (Doxycycline/Polymer-Lipid Encapsulation Matrix; PolyPid), a secured antibiotic drug reservoir for the local prevention and treatment of surgical infections.

Alexion Seeks Eculizumab Approval for Ultra-Rare Neuromuscular Disease

By March 08, 2017

The submission is supported by data from the Phase 3 REGAIN study, a randomized, double-blind, placebo-controlled trial which enrolled a total of 125 patients with anti-AChR Abs.

FDA to Review Vraylar for Maintenance Treatment of Schizophrenia

By March 08, 2017

Allergan announced that the Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) for Vraylar (cariprazine) for the addition of new data evaluating Vraylar for the maintenance of efficacy in adults with schizophrenia.

FDA Grants Orphan Drug Status to Plague Vaccine

By March 08, 2017

The Food and Drug Administration (FDA) has granted Orphan Drug designation to the recombinant rF1V plague vaccine (CSRA/DynPort) for pre-exposure prophylaxis of Yersinia pestis infection, also known as, the plague.

Volanesorsen Demonstrates Efficacy in Rare, Severe Hypertriglyceridemia

By March 06, 2017

Akcea and Ionis announced positive findings from the APPROACH study, a Phase 3 trial of volanesorsen for the reduction of triglycerides in patients with familial chylomicronemia syndrome (FCS).

Guselkumab Shows Superiority in Plaque Psoriasis Phase 3 Studies

By March 03, 2017

Janssen announced new findings from VOYAGE 2 and NAVIGATE, two pivotal Phase 3 studies evaluating guselkumab for the treatment of moderate to severe plaque psoriasis.

Breckenridge Launches Generic Pristiq

By March 01, 2017

Desvenlafaxine Succinate is available as 50mg and 100mg extended-release tablets.

FDA Grants Orphan Drug Status to Rare Lysosomal Storage Disorder Treatment

March 01, 2017

The FDA has granted Orphan Drug designation to Sangamo's genome editing product candidate, SB-913, for the treatment of Mucopolysaccharidosis Type II (MPS II).

Avelumab Gets Priority Review for Urothelial Carcinoma Indication

By March 01, 2017

The FDA has accepted and granted Priority Review to the Biologics License Application (BLA) for avelumab (Merck and Pfizer) for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) with disease progression on or after platinum-based therapy.

VZV Vaccine for Immunocompromised Patients Shows Promise in Phase 3 Trial

By February 28, 2017

Merck has announced positive results from a Phase 3 trial of V212, an investigational varicella zoster virus vaccine (VZV) for the prevention of herpes zoster (HZ) in immunocompromised patients.

FDA to Review Ready-to-Dilute Pemetrexed Formulation

By February 28, 2017

The FDA has accepted for review the New Drug Application (NDA) for Eagle's ready-to-dilute (RTD) Pemetrexed Injection 25mg/mL for the treatment of locally advanced or metastatic nonsquamous non-small cell lung cancer and mesothelioma (in combination with cisplatin).

Resolaris Granted Orphan Drug Status for Rare Genetic Myopathy

By February 28, 2017

The Food and Drug Administration (FDA) has granted Orphan Drug designation to Resolaris (aTyr Pharma) for the treatment of limb girdle muscular dystrophy (LGMD).

Drug for Catecholamine Resistant Hypotension Shows Promise in Phase 3 Study

By February 27, 2017

La Jolla announced positive data from the ATHOS-3 study which evaluated LJPC-501 (angiotensin II) for the treatment of catecholamine resistant hypotension (CRH).

NDA Re-Submitted for Novel Glaucoma Drug

By February 27, 2017

Valeant have re-submitted their NDA for latanoprostene bunod ophthalmic solution after receiving a Complete Response Letter from the FDA last summer.

Lurasidone Effective in Phase 3 Pediatric Bipolar Depression Study

By February 27, 2017

Sunovion announced that its Phase 3 study of Latuda (lurasidone HCI) in children aged 10 to 17 years with bipolar depression met its primary and secondary endpoints.

Dsuvia for Acute Pain Under FDA Review

By February 27, 2017

The FDA has accepted for review the New Drug Application (NDA) for Dsuvia (sufentanil sublingual tablet; AcelRx) for the treatment of moderate-to-severe acute pain in a medically supervised setting.

Fusidic Acid Looks Promising as Oral Therapy for ABSSSI

By February 24, 2017

The study achieved its primary endpoint, demonstrating that treatment with oral fusidic acid is non-inferior to oral linezolid.

FDA Grants Fast Track Status to Novel Therapy for Hearing Loss

By February 24, 2017

AM-111 is currently under investigation in two Phase 3 trials for patients with severe to profound idiopathic sudden sensorineural hearing loss.

Combination Biologic Granted Breakthrough Status for High Grade Glioma

By February 23, 2017

The Breakthrough Therapy designation was supported by safety, efficacy (durable, complete or partial tumor shrinkage) and patient survival data from three Phase 1 studies involving 126 patients with recurrent brain cancer.

Dextenza NDA Resubmission Accepted for Post-Surgical Ocular Pain

By February 23, 2017

The NDA for Dextenza was resubmitted in January 2017 following a Complete Response Letter that was issued in July 2016 due to concerns with deficiencies in manufacturing processes and controls.

Oliceridine as Effective as Morphine in Phase 3 Studies of Acute Post-Op Pain

By February 22, 2017

Oliceridine is a next generation injectable analgesic specifically designed to deliver the pain-reducing potential of an opioid but with fewer associated adverse effects.

Novel Oral MS Drug Effective, Safe in Phase 3 Study

By February 21, 2017

The primary endpoint was the reduction of annualized relapse rate (ARR) during the treatment period.

Unique Therapy for Advanced Heart Failure Granted Fast Track Status

By February 21, 2017

Ixmyelocel-T is an investigational autologous expanded multicellular therapy administered via transendocardial catheter-based injections.

Carbavance Gets Priority Review for Complicated UTI

By February 21, 2017

The study met the pre-specified primary endpoints and showed that treatment with Carbavance is associated with an overall success rate of 98.4%.

FDA Grants Priority Review to Antibody-Drug Conjugate for ALL

By February 21, 2017

The BLA submission is based on positive data from the INO-VATE 1022 study, a Phase 3 trial evaluating inotuzumab ozogamicin vs. standard of care chemotherapy in 326 adults with relapsed or refractory B-cell ALL.

FDA to Review Potential Neulasta Biosimilar

February 16, 2017

The Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for MYL-1401H (Mylan and Biocon), a proposed biosimilar candidate to Amgen's Neulasta (pegfilgrastim).

Doravirine Demonstrates Non-Inferiority in Phase 3 HIV Study

By February 15, 2017

Merck announced positive results from the pivotal Phase 3 study of doravirine (MK-1439), evaluating its efficacy and safety for the treatment of HIV-1 infection.vvvv

FDA to Review New Indication for Privigen

By February 14, 2017

Data from the Phase 3 PRIMA study suggests that Privigen may help decrease weakness and loss of motor function in people with CIDP.

FDA Fast Tracks Novel Combo Drug for Treatment Resistant Depression

By February 14, 2017

The FDA has granted Fast Track designation to the investigational drug AXS-05 (Axsome Therapeutics) for patients with treatment resistant depression (TRD).

Two-Drug HIV Combo as Effective as Three-, Four-Drug Regimen in Phase 3 Studies

By February 14, 2017

Janssen announced positive data from the SWORD Clinical Trial Program of the two-drug regimen dolutegravir (ViiV Healthcare) and rilpivirine (Janssen) for the maintenance treatment of HIV-1 infection in patients who have already achieved viral suppression.

Amgen Submits sBLA for Full Blincyto Approval

By February 14, 2017

Amgen has announced the submission of a supplemental Biologics License Application (BLA) for Blincyto (blinatumomab) to the Food and Drug Administration (FDA), to include overall survival data from the TOWER Phase 3 study.

Amgen Submits sBLA for Full Blincyto Approval

By February 14, 2017

Amgen has announced the submission of a supplemental Biologics License Application (BLA) for Blincyto (blinatumomab) to the Food and Drug Administration (FDA), to include overall survival data from the TOWER Phase 3 study.

Rescue Tx for Post-Op Nausea/Vomiting Effective in Pivotal Trial

By February 13, 2017

Acacia has announced positive results from its final pivotal Phase 3 study investigating BAREMSIS (amisulpride injection, formerly APD421) for the rescue treatment of patients who develop post-operative nausea and vomiting (PONV), despite having received prior antiemetic prophylaxis.

Positive Results Announced for Novel Microneedle Migraine Patch

By February 13, 2017

Zosano has announced positive results from their Phase 3 clinical trial of M207, the companies lead candidate for the treatment of migraine attacks.

Inhaled Levodopa Shows Promise for OFF Periods in PD Patients

By February 09, 2017

Acorda Therapeutics announced statistically significant results from the Phase 3 study of CVT-301, an investigational inhaled formulation of levodopa, for the treatment of OFF periods in patients with Parkinson's disease (PD) on an oral carbidopa/levodopa regimen.

FDA Accepts Zilretta NDA for Osteoarthritis Knee Pain

By February 07, 2017

The FDA has accepted for review the New Drug Application (NDA) for Zilretta (FX006; Flexion Therapeutics) for the treatment of patients with osteoarthritis (OA) of the knee.

FDA to Review New Film Formulation of Erectile Dysfunction Drug

By February 07, 2017

The FDA has accepted for review the New Drug Application (NDA) for Tadalafil Oral Soluble Film (Tadalafil OSF; MonoSol Rx) for the treatment of erectile dysfunction (ED).

FDA to Review Injection-Free GLP-1 Receptor Agonist Therapy for T2D

By February 06, 2017

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for ITCA 650 (Intarcia Therapeutics) for the treatment of type 2 diabetes (T2D)

GM1 Gangliosidosis Treatment Gets FDA's Orphan Drug Designation

By February 06, 2017

Lysogene announced that the Food and Drug Administration (FDA) has granted orphan designation to LYS-GM101, their gene therapy drug candidate for the treatment of GM1 Gangliosidosis (GM1).

Priority Review Granted to Fixed-Dose Pan-Genotypic HCV Regimen

By February 02, 2017

The FDA has accepted and granted Priority Review to the New Drug Application (NDA) of glecaprevir/pibrentasvir (G/P; AbbVie) for the treatment of genotypes 1-6 (GT1-6) chronic hepatitis C virus (HCV) infection.

Investigational Hemophilia B Gene Therapy Granted Breakthrough Status

By January 30, 2017

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to the investigational gene therapy, AMT-060 (uniQure), for the treatment of severe hemophilia B.

Mixed Results for Acne Gel Candidate in Phase 3 Trials

By January 27, 2017

Novan has announced results from its two Phase 3 trials of SB204 gel 4%, its investigational candidate for the treatment of acne vulgaris.

Encouraging Results for Lenvatinib in HCC Trial

By January 25, 2017

Eisai has announced positive topline results from their Phase 3 trial of lenvatinib (Lenvima), for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC).

Tocilizumab Gets Priority Review for Treatment of Giant Cell Arteritis

By January 24, 2017

Genentech has announced that the Food and Drug Administration (FDA) has accepted the company's Supplmental New Drug Application (sBLA) for Actemra (tocilizumab) to treat giant cell arteritis (GCA).

CMV Treatment Granted Orphan Drug Designation by FDA

By January 24, 2017

ViraCyte has announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to its candidate cytomegalovirus (CMV) treatment, Viralym-C.

FDA to Review Drug for Exertional Heat Stroke

By January 23, 2017

Eagle announced the complete submission to the Food and Drug Administration (FDA) of its New Drug Application (NDA) for Ryanodex for the treatment of exertional heat stroke (EHS).

Dextenza NDA Resubmitted for Post-Surgery Ocular Pain

By January 23, 2017

Ocular has announced that it has resubmitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for Dextenza (dexamethasone insert) 0.4mg, to treat ocular pain after ophthalmic surgery.

FDA Grants Deuterated CF Therapy Orphan Drug Designation

By January 20, 2017

The Food and Drug Administration (FDA) has granted Orphan Drug designation for Concert Pharmaceuticals' CTP-656 (deuterated ivacaftor) for the treatment of cystic fibrosis.

FDA to Review Briviact as Monotherapy for Partial-Onset Seizures

By January 19, 2017

UCB has filed a supplemental New Drug Application (sNDA) for Briviact (brivaracetam) as monotherapy to treat partial-onset seizures in patients ≥16 years with epilepsy.

FDA to Review Potential Single-Dose Therapy for Bacterial Vaginosis

By January 19, 2017

Symbiomix announced the submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) for Solosec (secnidazole oral granules) for the treatment of bacterial vaginosis (BV).

Cerebral Edema Treatment Gains Orphan Drug Status

By January 17, 2017

Remedy announced that their investigational treatment for severe cerebral edema in patients with acute ischemic stroke, Cirara, has been granted Orphan Drug Designation.