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FDA Pushes Back PDUFA Date on Titan’s Opioid Dependence NDA
Novartis Secures Breakthrough Therapy Designation for AML Candidate
Germany Rebuffs Cholesterol Drug
Shionogi’s Naldemedine Meets Primary Endpoint in Phase 3
FDA Awards Nivalis Cystic Fibrosis Candidate Fast Track Status Read More
Drug giant AstraZeneca has scored a big win in Europe, reeling in marketing authorization for Zurampic for patients with gout and a new dose of the heart medication Brilique. Read More
The UK’s National Institute for Health and Care Excellence delivered a stinging rebuke to Alexion Pharmaceuticals, saying it would not reimburse Kanuma for the treatment of lysosomal acid lipase deficiency until more evidence could support it. Read More
Amarin, FDA Get Another Month to Negotiate
Insect Prompts Baxter to Recall Lot of Sodium Chloride Irrigation
Zafgen’s Beloranib Reaches Primary Endpoint in Phase 2b Trial
Regulus Hep C Candidate Soars in Phase 2 Trial Read More
New FDA guidance is offering companies a way to test anti-clotting drugs for potentially fatal immune responses without the time or expense of additional clinical trials. Read More
Fresenius Medical Care will shell out $250 million to settle more than 400 lawsuits alleging harm from two of its drugs, GranuFlo and NaturaLyte, under a proposed settlement announced Wednesday. Read More
Notification requirements under the federal biosimilars law are getting renewed attention with two recent court filings: one, a petition to the U.S. Supreme Court, and the other an amicus brief before the U.S. Court of Appeals for the Federal Circuit. Read More
Industry groups have taken aim at an FDA recommendation on creating committees for assessing safety for INDs, saying the agency should adopt a more flexible approach. Read More