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The FDA approved Amgen’s Repatha late Thursday for some patients who are not able to control low-density lipoprotein cholesterol using standard treatment options, making it the second PCSK9 inhibitor to receive the agency’s blessing. Read More
Amgen is seeking FDA approval for etelcalcetide — the first calcimimetic agent for secondary hyperparathyroidism in patients with chronic kidney disease that can be administered intravenously at the end of a dialysis session. Read More
The FDA and European Medicines Agency have accepted new drug applications for Boehringer Ingelheim’s Gilotrif as a treatment option for patients with advanced squamous cell lung cancer that has progressed after treatment with first-line chemotherapy. Read More
Novartis scored its second FDA approval for Promacta since acquiring the drug from GlaxoSmithKline in March, this time to treat children ages 1 to 5 with a rare blood disorder that causes low platelet counts. Read More
The proposal includes accelerated approvals of drugs, specified timelines for deciding applications and increased public access to information. Read More
The FDA has granted rare pediatric disease designation to two investigational Duchenne Muscular Dystrophy therapies — Sarepta Therapeutics’ eteplirsen and BioMarin Pharmaceutical’s drisapersen — the first DMD candidates to win the designation. Read More