The House Appropriations Committee proposed a 2020 draft fiscal year funding bill. The FDA would receive a 6 percent increase in discretionary funding over 2019, amounting to a $184 million bump.
The return on R&D investment for leading biopharmaceutical manufacturers fell to a nine-year low while the U.S. FDA approved a record-breaking amount of novel medicines during 2018.
The top performers of the launch class of 2016 have very little in common – aside from the fact that none of them came from a “classic” big pharma house.
Takeda’s Gattex (teduglutide) won approval for a new indication from the U.S. Food and Drug Administration: for pediatric patients 1 year of age and older with Short Bowel Syndrome who need additional nutrition or fluids from intravenous feeding.
UCB announced that the U.S. Food and Drug Administration approved a New Drug Application for the company’s anti-epileptic drug Nayzilam (midazolam) nasal spray CIV.
The U.S. Food and Drug Administration issued a recall of surgical staplers made by Johnson & Johnson’s Ethicon unit, warning that the use of the devices could cause serious injury or death.
FDA approves first anticoagulant for pediatric patients to treat potentially life-threatening blood clots
The U.S. FDA approved Fragmin (dalteparin sodium) injection, for subcutaneous use, to reduce the recurrence of symptomatic venous thromboembolism in pediatric patients 1 month of age and older.
Roche: FDA approves drug combo Venclexta plus Gazyva for previously untreated chronic lymphocytic leukemia
The U.S. Food and Drug Administration approved a treatment using Venclexta plus Gazyva for people with previously untreated chronic lymphocytic leukemia.
EMD Serono and Pfizer announced that the U.S. FDA approved Bavencio (avelumab) in combination with Inlyta (axitinib) for the first-line treatment of patients with advanced renal cell carcinoma.
Independent experts on an advisory panel to the U.S. Food and Drug Administration voted against Daiichi Sankyo Co. Ltd.’s treatment for adults with a type of acute myeloid leukemia.
The U.S. FDA approved Regeneron Pharmaceuticals Inc.’s Eylea (aflibercept) Injection for all stages of diabetic retinopathy, which is the leading cause of vision loss in diabetic patients.
Cellectar Receives FDA Fast Track Designation for CLR 131 in Relapsed or Refractory Multiple Myeloma
Cellectar Biosciences Inc. announced that the U.S. Food and Drug Administration granted Fast Track Designation for CLR 131 in fourth line or later relapse/refractory multiple myeloma.