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Regeneron has won yet another indication for its Eylea injection, this time for patients with diabetic macular edema who develop retinopathy. Read More
The National Institute for Health and Care Excellence yesterday recommended that the National Health Service cover drugs for acute coronary syndrome and type 2 diabetes, but turned down one for multiple myeloma. Read More
Hundreds of children as young as two years old will now be able to get Vertex Pharmaceuticals’ game-changing cystic fibrosis treatment, following FDA approval Thursday. Read More
The FDA approved Asklepion Pharmaceuticals’ Cholbam, the first treatment for children and adults with single-enzyme bile acid disorders and peroxisomal disorders, under its pediatric rare disease priority review voucher program. Under the terms Congress set for the program, the FDA must now phase it out within 12 months unless it is reauthorized. Read More
Sponsors of brand, generic and biosimilar drugs applying for marketing authorization through the EU’s centralized procedure must begin including facility inspection information in their applications. Read More
The FDA March 6 gave a green light to the first U.S. biosimilar, finding Sandoz’s Zarxio clinically comparable to Amgen’s blockbuster chemotherapy product Neupogen. Read More
The House yesterday passed a bill that would allow drugs to be sold before the Drug Enforcement Agency permanently assigns them to a controlled substance schedule. Read More