Amneal Pharmaceuticals Advances Key Strategic Initiatives with FDA Submissions and Approvals
Amneal Pharmaceuticals Advances Key Strategic Initiatives with FDA Submissions and Approvals Amneal Pharma, a global leader in pharmaceuticals, today announced the progression of two significant strat ...
BridgeBio Pharma’s Attruby™ Approved by FDA for Treating Transthyretin Amyloid Cardiomyopathy
BridgeBio Pharma's Attruby™ Approved by FDA for Treating Transthyretin Amyloid Cardiomyopathy BridgeBio Pharma, Inc., a biopharmaceutical company pioneering treatments for genetic diseases, today anno ...
FDA Approves AbbVie’s VYALEV for 24-Hour Treatment of Advanced Parkinson’s Disease
AbbVie announced that the U.S. FDA has approved VYALEV™ (foscarbidopa and foslevodopa) as the first and only subcutaneous 24-hour infusion of levodopa-based therapy for treating motor fluctuations in ...
FDA Approves Astellas’ VYLOY for HER2-Negative Gastric and GEJ Adenocarcinoma
Astellas Pharma Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved VYLOY™ (zolbetuximab-clzb) for use in combination with fluoropyrimidine- and platinum-containing chemot ...
Glaukos’ Epioxa Achieves Positive Phase 3 Results for Keratoconus Treatment
Glaukos Corporation announced that the second Phase 3 confirmatory pivotal trial for Epioxa™ (Epi-on) met its pre-specified primary efficacy endpoint. This next-generation corneal cross-linking iLink ...
FDA Grants Rare Pediatric Disease Designation to Papillon Therapeutics’ PPL-001 for Friedreich’s Ataxia
Papillon Therapeutics Inc., a clinical-stage biotechnology company focused on developing multi-systemic genetic medicines to address the root causes of inherited diseases, has announced that the U.S. ...
FDA Grants Orphan Drug Designation to Immuneering’s IMM-1-104 for Pancreatic Cancer Treatment
Immuneering Corporation, a clinical-stage oncology company focused on developing universal RAS/RAF medicines for a broad range of cancer patients, has announced that the U.S. Food and Drug Administrat ...
Pfizer’s HYMPAVZI Gains FDA Nod for Hemophilia A and B Without Inhibitors
Pfizer Inc. announced the FDA approval of HYMPAVZI™ (marstacimab-hncq) for routine prophylaxis aimed at preventing or reducing the frequency of bleeding episodes. This approval covers both adult and p ...
FDA Approves Accord BioPharma’s IMULDOSA for Treating Chronic Inflammatory Conditions
Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd., which focuses on oncology, immunology, and critical care therapies, has announced the FDA approval of IMULDOSA (uste ...
Stoke Therapeutics Receives FDA Approval to Administer Higher Single Dose of STK-001 in MONARCH Trial for Dravet Syndrome
Stoke Therapeutics' experimental therapy for Dravet syndrome is being tested in the U.S.-based Phase 1/2a MONARCH trial, where a higher single dose of STK-001 will be administered. The U.S. Food and D ...