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The FDA is urging two Florida compounders to reassess their operations after finding significant issues with GMPs and sterile drug practices during inspections. Read More
The FDA has delivered PTC Therapeutics a stinging rebuke, sending the company a refuse to file letter for Translarna, its candidate for the treatment of nonsense mutation Duchenne muscular dystrophy. Read More
The FDA has accepted Sanofi’s application for expedited review of its once-daily, fixed-dose combination of insulin glargine and GLP-1 receptor agonist lixisenatide for Type 2 diabetes. Read More
Chimerix Cans 2 Phase 3 Trials of Brincidofovir
Pfizer Nabs Additional Indication for Breast Cancer Drug
Trevena’s Oliceridine Nabs Breakthrough Therapy Designation
Bellicum Wins Orphan Drug Status for BPX-501
Amgen, UCB’s Osteoporosis Candidate Meets Primary Endpoint Read More