Drugs in the Pipeline
Gilead Sciences announced positive results from the AMBITION study, a Phase 3/4 trial of first-line combination therapy with Letairis (ambrisentan) and tadalafil in patients with WHO/NYHA functional class II and III pulmonary arterial hypertension (PAH).
The Food and Drug Administration (FDA) has granted SYM-1219 (secnidazole, Symbiomix) Fast Track designation for the treatment of bacterial vaginosis (BV).
The Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for eteplirsen (Sarepta) for the treatment of Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping.
The Food and Drug Administration (FDA) has granted AT001 (Audentes) Orphan Drug designation for the treatment of X-Linked Myotubular Myopathy (XLMTM).
Intarcia Therapeutics has announced that the Phase 3 trial of ITCA 650 (exenatide) demonstrated positive top-line results in reducing HbA1c in patients with type 2 diabetes following a year of treatment.
Genentech announced that the Phase 2 study of atezolizumab met its primary endpoint and shrank tumors in people with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease expressed PD-L1 (Programmed Death Ligand-1).
The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for BromSite (0.075% bromfenac; InSite Vision) for the treatment of inflammation and prevention of ocular pain post-cataract surgery.
The Food and Drug Administration (FDA) has accepted for review the sBLA for Keytruda (pembrolizumab, Merck) for the first-line treatment of unresectable or metastatic melanoma patients.
The Food and Drug Administration (FDA) has granted Orphan Drug designation to SER-109 (Seres Therapeutics) for the prevention of recurrent Clostridium difficile infection (CDI) in adults.
The Phase 3 trial for Fycompa (perampanel, Eisai) demonstrated statistically significant results when used as adjunctive therapy in the treatment of primary generalized tonic-clonic (PGTC) seizures in patients 12 years and older.
- Nine Factors That Appear to Elevate Alzheimer's Risk
- NSAIDs Linked to Long-Term Colon Cancer Risk Reduction
- Clinical Suspicion Leads to Uncommon Diagnosis in Patient With High Fever
- What a New Study Says About Omega-3s and Brain Health
- Measles and 'Immune Amnesia': Why Vaccination Could Also Prevent Other Diseases