FDA Designates Orphan Drug for Rare Degenerative Eye Disease

The FDA has designated Recombinant Human Nerve Growth Factor (rhNGF; Dompe) Orphan Drug status for the treatment of neurotrophic keratitis.

Neratinib Demonstrates Potential in Breast Cancer Trial

Puma Biotechnology announced results from its Phase 3 ExteNET trial of neratinib (PB272) for the extended adjuvant treatment of breast cancer.

FDA Accepts sBLA, Grants Priority Review for Avastin in Ovarian Cancer

The FDA grants Genentech's sBLA for Avastin (bevacizumab) plus chemotherapy Priority Review for the treatment of women with recurrent platinum-resistant ovarian cancer.

Status Epilepticus Therapy Granted Fast Track Status

The FDA has designated Fast Track status to SAGE-547 (SAGE Therapeutics) for the treatment of adult patients with refractory status epilepticus who have not responded to standard regimens.

RG-102 Desginated Orphan Drug for Alport Syndrome

The FDA has granted Orphan Drug designation to RG-012 (Regulus), a single stranded, chemically modified oligonucleotide that binds to and inhibits the function of microRNA-21 for the treatment of Alport syndrome.

Positive Phase 3 Results in Secondary Hyperparathyroidism with AMG 416

Positive Phase 3 results announced for AMG 416 (Amgen) for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease (CKD), receiving hemodialysis.

Eylea Efficacious in Diabetic Macular Edema Trial

Regeneron announced results from its Phase 3 VIVID-DME trial of Eylea (afilbercept) injection for the treatment of diabetic macular edema (DME).

FDA Designates Antifungal Agent QDIP Status

The FDA has designated isavuconazole (Astellas) as a Qualified Infectious Disease Product (QDIP) for the treatment of invasive candidiasis.

Nintedanib Granted Breakthrough Therapy for Idiopathic Pulmonary Fibrosis

The FDA has granted Breakthrough Therapy designation to Boehringer Ingelheim's nintedanib for the treatment of idiopathic pulmonary fibrosis (IPF).

Positive Phase 3 Results for Once Weekly Prophylaxis for Hemophilia B

Positive Phase 3 Results for Once Weekly Prophylaxis for Hemophilia B

Pfizer announced positive results of a Phase 3 study comparing BeneFIX Coagulation Factor IX (Recombinant) to on-demand treatment in patients with moderately severe to severe hemophilia B.

Olysio + Sofosbuvir sNDA Designated Priority Review

The FDA has designated Priority Review to the supplemental New Drug Application (sNDA) for Olysio (simeprevir) in combination with sofosbuvir for 12 weeks of treatment in adults with genotype 1 chronic hepatitis C.

FDA Accepts NDA Resubmission for PA32540/PA8140

The FDA has accepted for review Pozen's resubmitted New Drug Application (NDA) for aspirin and omeprazole (PA32540/PA8140) delayed-release tablets.

Octagam 10% Approved for Platelet Disorder

The FDA has approved Octagam 10% [Immune Globulin Intravenous (Human)] liquid preparation for the treatment of adults with chronic immune thrombocytopenic purpura (ITP).

Priority Review, sBLA Granted for Cervical Cancer Tx

The FDA has accepted Genentech's supplemental Biologics License Application (sBLA) and granted Priority Review for Avastin (bevacizumab) plus chemotherapy for the treatment of women with persistent, recurrent or metastatic cervical cancer.

Methylphenidate XR-ODT Effective in Phase 3 ADHD Study

Neos Therapeutics announced the completion of a positive Phase 3 study for its investigational methylphenidate XR-ODT (NT-0102) drug candidate in children with Attention Deficit/Hyperactivity Disorder (ADHD).

Albuterol MDPI NDA Accepted for Review for Bronchospasms

The FDA has accepted for review Teva's New Drug Application (NDA) for albuterol multi-dose dry-powder inhaler (MDPI) for the treatment or prevention of bronchospasm in patients with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm (EIB) both in patients ≥12 years of age.

FDA Accepts Investigational Basal Insulin NDA for Review

The FDA has accepted for review the New Drug Application (NDA) for Toujeo (insulin glargine [rDNDA origin]; Sanofi) injection, an investigational basal insulin.

NDA Submitted for Brexpiprazole in Schizophrenia, MDD

Otsuka and Lundbeck announced the submission of a New Drug Application (NDA) to the FDA for brexpiprazole for the treatment of schizophrenia and as adjunctive treatment of major depressive disorder (MDD).

sNDA Submitted for Invega Sustenna Label Expansion

Janssen submitted a supplemental New Drug Application (sNDA) to the FDA for a label change to include new data demonstrating significantly delayed time to relapse in patients taking Invega Sustenna (paliperidone palmitate) compared to other selected oral antipsychotics for the treatment of schizophrenia.

Combination Melanoma Therapy Effective in Phase 3 Trial

Genentech announced results from coBRIM, a Phase 3 trial evaluating cobimetinib in combination with Zelboraf (vemurafenib) in previously untreated patients with unresectable locally advanced or metastatic melanoma harboring the BRAFV600 mutation.

Isavuconazole NDA Submitted for Invasive Fungal Infections

Astellas has submitted a New Drug Application (NDA) to the FDA for isavuconazole for the treatment of invasive aspergillosis and invasive mucormycosis.

Secukinumab Demonstrates Potential in Phase 3 Psoriasis Trials

Novartis announced results from two Phase 3 trials evaluating secukinumab in patients with moderate-to-severe plaque psoriasis.

Positive Results for AuriPro in Pediatric Patients

Otonomy announced positive results from two Phase 3 trials of AuriPro (ciprofloxacin) for intra-operative treatment of middle ear effusion in pediatric patients requiring tympanostomy tube placement surgery.

Low-Volume, Short Infusion Time Tx Designated Orphan Drug for Hematological Cancers

The FDA has granted Orphan Drug designation to bendamustine HCl (Eagle Pharmaceuticals) for the treatment of chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin's lymphoma (NHL).

NDA Granted Priority Review for Hydrocodone Bitartrate

The FDA has granted Priority Review designation to hydrocodone bitartrate tablets (HYD), an investigational once-daily pain medication.

ENMD-2076 Designated Orphan Drug for Hepatocellular Carcinoma

CASI Pharmaceuticals announced that the FDA has granted Orphan Drug designation to ENMD-2076 for the treatment of hepatocellular carcinoma (HCC).

NDA for Idiopathic Pulmonary Fibrosis Drug Granted Priority Review

The FDA has accepted for filing and granted priority review designation to Boehringer Ingelheim's New Drug Application (NDA) for nintedanib for the treatment of idiopathic pulmonary fibrosis (IPF).

Positive Outcomes for Sebelipase Alfa in Lysosomal Acid Lipase Deficiency Trial

Synageva BioPharma announced that the Phase 3 ARISE trial of sebelipase alfa in patients with lysosomal acid lipase deficiency (LAL Deficiency) met the primary endpoint.

Somatuline Depot sNDA Submitted for GEP-NETs

Ipsen Biopharmaceuticals announced that it has submitted a supplemental New Drug Application (sNDA) to the FDA for Somatuline Depot 120mg injection for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

Positive Response with Repeat Rifaximin Treatment in IBS-D

Salix announced results from the Phase 3 TARGET 3 trial evaluating the use of repeat treatment with rifaximin 550mg in patients with irritable bowel syndrome with diarrhea (IBS-D).

Emend Shows Potential in Pediatric Chemotherapy-Induced Nausea, Vomiting

Merck announced results from a Phase 3 Emend (aprepitant) study in the prevention of chemotherapy-induced nausea and vomiting (CINV) in pediatric cancer patients, aged 6 months to 17 years.

Pradaxa Antidote, Idarucizumab Designated Breakthrough Therapy

The FDA has granted Breakthrough Therapy designation to idarucizumab (Boehringer Ingelheim), an investigational fully humanized antibody fragment (Fab), being evaluated as a specific antidote for Pradaxa (dabigatran etexilate mesylate).

Superior Overall Survival with Nivolumab in Skin Cancer Trial

Bristol-Myers Squibb's Phase 3 study, CheckMate -066 evaluating nivolumab vs. dacarbazine (DTIC) in patients with previously untreated BRAF wild-type advanced melanoma was stopped early due to an analysis demonstrating evidence of superior overall survival in patients receiving nivolumab compared to the control arm.

Combo Cystic Fibrosis Therapy Promising in Trials

Vertex announced results from two Phase 3 studies of lumacaftor in combination with ivacaftor in patients with cystic fibrosis (CF) who have two copies of F508del mutation in the CFTR gene.

FDA Accepts Combination Antibiotic NDA for Priority Review

The FDA has accepted Cubist's NDA for ceftolozane/tazobactam with priority review for the treatment of complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI).

Aripiprazole Lauroxil Effective in Schizophrenia Trial

Alkermes announced results from its Phase 3 trial of aripiprazole lauroxil, an investigational drug for the treatment of schizophrenia.

Empagliflozin NDA Resubmitted to FDA

Empagliflozin NDA Resubmitted to FDA

Boehringer Ingelheim and Eli Lilly and Company announced the resubmission of the empagliflozin NDA to the FDA for the treatment of adults with type 2 diabetes.

Results for Perampanel in Tonic-Clonic Seizure Trial

Eisai announced results from a Phase 3 Study 332 trial of perampanel, an AMPA receptor antagonist in patients with primary generalized tonic-clonic (PGTC) seizures.

Mocetinostat Granted Orphan Drug for MDS

The FDA has granted Orphan Drug designation to mocetinostat (Mirati Therapeutics), a selective HDAC inhibitor for the treatment of myelodysplastic syndrome (MDS).

DNX-2401 Granted Fast Track for Recurrent Glioblastoma

The FDA has granted Fast Track status for DNX-2401 (DNAtrix), a replication competent adenovirus for patients with recurrent glioblastoma.

Soliris Designated Orphan Drug for Rare Neurological Disorder

The FDA has granted Orphan Drug designation to Soliris (eculizumab) for the treatment of patients with myasthenia gravis.

Pfizer Submits BLA for Meningococcal B Vaccine

Pfizer announced the submission of a BLA to the FDA for bivalent recombinant LP2086 (rLP2086), a vaccine candidate for the prevention of invasive meningococcal disease caused by Neisseria meningitides serogroup B in 10-25 year olds.

NDA Accepted for Review for Fixed-Dose Combo Hypertension Drug

The FDA has accepted Symplmed's NDA for review for Prestalia, a fixed-dose combination (FDC) of perindopril arginine and amlodipine besylate for the treatment of hypertension.

New Data on Basal Insulin Peglispro Mechanism Released

Eli Lilly and Company released new data regarding the mechanism of action of basal insulin peglispro (BIL) at the 2014 American Diabetes Association Scientific Sessions.

Once-Weekly Dulaglutide Non-Inferior to Once-Daily Liraglutide

At the 2014 American Diabetes Association Scientific Sessions, Eli Lilly and Company presented favorable results from dulaglutide's sixth AWARD trial.

Daclizumab HYP Efficacious in Relapsing Multiple Sclerosis Trial

Biogen Idec and AbbVie announced results from the Phase 3 DECIDE clinical trial evaluating the use of subcutaneous daclizumab high-yield process (DAC HYP) vs. intramuscular interferon beta-1a (IFN β-1a) in patients with relapsing multiple sclerosis (RRMS).

Acute Myelogenous Leukemia Treatment Designated Orphan Drug

The FDA has granted Orphan Drug Designation to AG-221 (Agios Pharmaceuticals), an oral first-in-class IDH2 mutant inhibitor for the treatment of patients with acute myelogenous leukemia (AML).

NDA for Chronic Genotype 1 HCV Accepted for Priority Review

The FDA has accepted Enanta's NDA for priority review for AbbVie's all-oral, interferon-free regimen in the treatment of adults with chronic genotype 1 hepatitis C virus infection.

Results Announced for New Formulation of Hylenex

Halozyme Therapeutics announced results from CONSISTENT 1, a trial evaluating the use of Hylenex recombinant (hyaluronidase human injection) and a new formulation of Hylenex when used as pretreatment at the insulin infusion site in patients with type 1 diabetes receiving continuous subcutaneous insulin infusion compared to no pre-treatment, at the 2014 American Diabetes Association Scientific Sessions.

Combo Once-Daily Insulin Therapy May be Effecatious in T2D

New Phase 3a results demonstrate that IDegLira, an investigational once-daily single injection combination of insulin degludec and liraglutide, for the treatment of patients with type 2 diabetes, maintained its glucose-lowering effect and confirmed safety evaluations for up to one year, as presented at the 2014 American Diabetes Association Scientific Sessions.

Investigational Combo Tablet Demonstrates Significant Reduction in HbA1c

The investigational combination tablet of empagliflozin and linagliptin reduced blood glucose levels in patients with type 2 diabetes as presented by Boehringer Ingelheim and Eli Lilly and Company at the 2014 American Diabetes Association Scientific Sessions.

Investigational Diabetes Therapy May Reduce HbA1c

Isis Pharmaceuticals announced results from its Phase 2 study of ISIS-GCGRRX in patients with type 2 diabetes uncontrolled on stable metformin therapy at the 2014 American Diabetes Association Scientific Sessions.

Rare Skin Disorder Therapy Designated Orphan Drug

The FDA has granted Orphan Drug designation to Fibrocell Science's genetically-modified autologous human fibroblasts for the treatment of dystrophic epidermolysis bullosa (DEB).

Phase 2 Results of Brodalumab for Psoriatic Arthritis

Phase 2 Results of Brodalumab for Psoriatic Arthritis

The monoclonal antibody brodalumab significantly improves response rates among patients with psoriatic arthritis, according to a phase 2 study.

Orphan Drug Designation for MI-100 in Stargardt's Disease

Makindus announced that it has received orphan drug designation from the FDA for MI-100 for the treatment of Stargardt's Disease.

Novel PCOS Drug Granted Orphan Status

EffRx announced that the FDA has granted orphan drug designation to EX404 for the treatment of pediatric polycystic ovary syndrome (PCOS).

Migraine Drug Meets Primary Endpoint in Phase 3 Trial

Migraine Drug Meets Primary Endpoint in Phase 3 Trial

Avanir announced that the COMPASS trial met the primary efficacy endpoint in the assessment of AVP-825.

FDA Accepts, Grants Priority Review for Imbruvica's sNDA

Pharmacyclics announced that the FDA has accepted for filing the supplemental New Drug Application (sNDA) to extend the indication of Imbruvica (ibrutinib) to the treatment of patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) who have received at least one prior therapy for a full approval.

Vatiquinone Receives Orphan Status for Leigh Syndrome

Edison Pharmaceuticals announced that the FDA has granted Orphan Drug status to vatiquinone (EPI-743) for the treatment of Leigh syndrome.

OCU100 Granted Orphan Drug for Retinitis Pigmentosa

Ocugen announced that OCU100 has received orphan drug status from the DA for the treatment of retinitis pigmentosa (RP).

Single Dose Antibiotic Effective for Skin Infections, Including MRSA

The Medicines Company announced the results from its Phase 3 SOLO 1 trial evaluating Orbactiv (oritavancin), an investigational intravenous antibiotic for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused or suspected to be caused by Gram-positive bacteria including MRSA.

Evolocumab Shows Efficacy in Reducing LDL-C

Amgen announced detailed data from its Phase 3 TESLA study evaluating evolocumab (AMG 145) in patients with homozygous familial hypercholesterolemia (HoFH).

FDA Accepts for Review Resubmitted Lemtrada sBLA

The FDA has accepted for review the resubmission of Genzyme's supplemental Biologics License Application (sBLA) for Lemtrada (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis.

Safinamide NDA Submitted for Parkinson's Disease

Newron Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA for safinamide as an add-on therapy to dopamine agonists or to levodopa in patients with early or mid- to late-stage Parkinson's disease.

DCCR Designated Orphan Drug for Prader-Willi Syndrome

Essentialis announced that the FDA has granted orphan drug designation to diazoxide choline, the active ingredient in DCCR for the treatment of Prader-Willi syndrome.

Pain Drug MNK-155 Being Reviewed by FDA

Mallinckrodt announced that the FDA has accepted a New Drug Application (NDA) for filing for MNK-155, an investigational extended-release pain medication.

Tofacitinib Effective in Phase 3 Psoriasis Retreatment Study

Pfizer announced results from the OPT (Oral treatment Psoriasis Trial) Retreatment study (A3921111) assessing tofacitinib for the treatment of adults with moderate-to-severe chronic plaque psoriasis.

Combination COPD Agent May Improve Lung Function

Boehringer Ingelheim announced results from the Phase 3 VIVACITO study evaluating the effect of the fixed-dose combination of tiotropium and olodaterol (T + O FDC) delivered via the Respimat inhaler, on lung function in people with chronic obstructive pulmonary disease (COPD).

Humira Designated Orphan Drug for Rare Eye Disorders

The FDA has granted Orphan Drug designation to Humira (adalimumab; AbbVie) for the treatment of non-infectious intermediate, posterior, or pan-uveitis, or chronic non-infectious anterior uveitis.

NSCLC Therapy Granted Breakthrough Therapy Designation

The FDA has granted Breakthrough Therapy designation to CO-1686 (Clovis Oncology) as monotherapy for the treatment of second-line EGFR mutant non-small cell lung cancer (NSCLC) in patients with the T790M mutation.

Pirfenidone Results Announced in IPF

InterMune announced results from the Phase 3 ASCEND study evaluating pirfenidone in patients with idiopathic pulmonary fibrosis (IPF).

Nintedanib Demonstrates Potential in Idiopathic Pulmonary Fibrosis Trials

Boehringer Ingelheim announced results from the Phase 3 INPULSIS-1 and -2 trials for nintedanib being studied in people with idiopathic pulmonary fibrosis (IPF).

Elotuzumab Granted Breakthrough Therapy for Multiple Myeloma

The FDA has granted Breakthrough Therapy Designation to elotuzumab (Bristol-Myers Squibb and AbbVie), for use in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in patients who have received one or more prior therapies.

Complete Response Letter Issued for Cardiac Drug

Novartis announced that it has received a Complete Response Letter (CRL) from the FDA regarding the Biologics License Application (BLA) for RLX030 (serelaxin) for the treatment of acute heart failure (AHF).

Liraglutide Shows Potential in Weight Management Trial

Novo Nordisk announced results from its Phase 3a trial evaluating liraglutide 3mg, an investigational once-daily glucagon-like peptide-1 (GLP-1) analogue for weight management. Liraglutide regulates appetite and food intake by decreasing hunger and increasing feelings of fullness and satiety after eating.

Gilotrif May Improve Overall Survival in Lung Cancer

Boehringer Ingelheim announced new overall survival data from two Phase 3 trials, LUX-Lung 3 and LUX-Lung 6 for Gilotrif (afatinib) in patients with advanced NSCLC whose tumors have a EGFR mutation.

Necitumumab Efficacious at Improving Overall Survival in NSCLC Trial

Eli Lilly and Company announced results from the largest Phase 3 SQUIRE trial of necitumumab for the first-line treatment of squamous non-small cell lung cancer (NDCLC).

Nivolumab Designated Breakthrough Therapy for Hodgkin Lymphoma

The FDA has granted nivolumab (Bristol-Myers Squibb) Breakthrough Therapy designation for the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant and brentuximab.

Investigational Drug May Improve Vascular Access in Hemodialysis

Proteon Therapeutics announced results from a Phase 2 clinical trial of PRT-201 to use to prolong the patency and reduce the failure of hemodialysis vascular access in patients with chronic kidney disease (CKD).

Results Announced for Isavuconazole in Antifungal Study

Astellas announced safety and efficacy results from its Phase 3 SECURE trial with isavuconazole for the treatment of invasive asperigillosis.

Invega Sustenna sNDAs Submitted for Schizoaffective Disorder

Janssen has submitted sNDAs to the FDA for Invega Sustenna (paliperidone palmitate) for the treatment of schizoaffective disorder as either monotherapy or adjunctive therapy.

Combination Antibiotic Results Announced for Complicated Infections

Cubist announced results from a Phase 3 trial of ceftolozane/tazobactam for the treatment of serious infections including complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI).

Results Announced for Ganetespib in NSCLC Trial

Synta Pharmaceuticals announced final results from the GALAXY-1 trial for ganetespib in patients with advanced non-small lung cancer (NSCLC) with adenocarcinoma histology most likely to benefit from second-line treatment.

Exparel sNDA Submitted for Nerve Block Indication

Pacira Pharmaceuticals has submitted a sNDA to the FDA for an expanded nerve block indication for Exparel (bupivacaine) liposome injectable suspension.

sNDA for Combination Chronic Hepatitis C Therapy Submitted

Janssen R&D has submitted a sNDA to the FDA for simeprevir in combination with sofosbuvir for the treatment of genotype 1 chronic hepatitis C (HCV) in treatment-naïve patients with advanced fibrosis and null responders with all stages of liver fibrosis.

FDA Accepts BLA for Advanced Melanoma Therapy

The FDA has accepted for review Merck's BLA for MK-3475 for the treatment of unresectable or metastatic melanoma in patients who have been previously treated with ipilimumab.

FDA Accepts Xtandi sNDA for Filing

The FDA has accepted for filing a sNDA to extend the indication for Xtandi (enzalutamide; Astellas Pharma and Medivation) capsules for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy.

Signifor LAR Effective in Acromegaly Study

Novartis announced results from a Phase 3 trial for Signifor LAR (pasireotide LAR; SOM230) in patients with acromegaly for whom current standard of care provides inadequate disease control.

FDA Issued CRL for Plumiaz Nasal Spray

The FDA has issued a Complete Response Letter (CRL) for Acorda's NDA for Plumiaz (diazepam) Nasal Spray for the treatment of patients with epilepsy who experience cluster seizures.

SAGE-547 Designated Orphan Drug for Status Epilepticus

SAGE Therapeutics announced that the FDA has granted Orphan Drug designation to SAGE-547 for the treatment of super-refractory status epilepticus (SRSE).

Iroko Presents Results for its Phase 3 Pain Studies

Iroko Pharmaceuticals presented results from two Phase 3 studies of its SoluMatrix, a nonsteroidal anti-inflammatory drug (NSAID) portfolio, for Tivorbex (indomethacin) and Zorvolex (diclofenac) at the American Pain Society Annual Meeting.

Pfizer's Pain Therapy Efficacious in Pain Scores

Pfizer announced results from three pivotal studies of investigational ALO-02 (oxycodone hydrochloride and naltrexone extended-release capsules) at the American Pain Society (APS) Annual Meeting.

Results Released for Dry Eye Trial with Lifitegrast

Shire announced results from its Phase 3 OPUS-2 study and Phase 3 SONATA safety study investigating lifitegrast (5.0% ophthalmic solution) in adults with dry eye disease.

FDA to Review sNDA for Abilify Maintena

The FDA has accepted for review Otsuka and Lundbeck's supplemental New Drug Application (sNDA) for Abilify Maintena (aripiprazole extended-release injectable suspension) to broaden the indication for treatment of patients in the acute phase of schizophrenia.

Purdue Submits NDA for Hydrocodone Bitartrate Tabs

Purdue Pharma announced that it has submitted a New Drug Application (NDA) to the FDA for once-daily hydrocodone bitartrate tablet for chronic pain.

Hydrocodone Extended-Release Tabs Effective in Pain Trial

Teva announced positive results from Study 3103, a Phase 3 study with hydrocodone bitartrate extended release tablets (CEP-33237) for moderate to severe chronic low back pain.

Erdosteine Designated Orphan Drug for Bronchiectasis

The FDA has granted Orphan Drug status to Edmond Pharma's erdosteine, a molecule being developed for the treatment of bronchiectasis.

Results for Patisiran in TTR-Mediated Amyloidosis

Alnylam Pharmaceuticals announced new clinical data for patisiran (ALN-TTR02), an RNAi therapeutic targeting transthyretin (TTR) being developed for the treatment of TTR-mediated amyloidosis (ATTR).

Phase 2 Stem Cell Study for ALS Approved

Brain Storm Cell Therapeutics announced that the Phase 2 clinical trial of NurOwn for patients with Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig's Disease, has received FDA approval to begin.

POZEN to Address CRL Issued for PA32540/PA8140

The FDA has issued a Complete Response Letter (CRL) to POZEN's New Drug Application (NDA) for aspirin and omeprazole (PA32540/PA8140) delayed-release tablets.

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