You are here: Industry Insights > FDA

News List

FDA advisory committee backs Lynparza use for pancreatic cancer pharmaceutical-technology
December 19, 2019
The US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) has recommended the approval of AstraZeneca-Merck (MSD)’s Lynparza (olaparib) to treat ...
FDA to Allow States to Import Prescription Drugs From Other Countries drugs
December 19, 2019
Federal health officials have unveiled plans to allow prescription drug imports from Canada and other foreign nations.
Pfizer, Astellas' Xtandi matches J&J's Erleada with new FDA nod fiercepharma
December 18, 2019
Pfizer and Astellas' stalwart prostate cancer med Xtandi has watched as Johnson & Johnson's challenger, Erleada, picked up the lead in the metastatic, castration-sensitive form of the disease.
Salarius Receives FDA Fast Track Designation for Seclidemstat americanpharmaceuticalreview
December 18, 2019
Salarius Pharmaceuticals announced its lead investigational drug candidate, Seclidemstat, has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for ...
Drug approved which reduces risk of cardiovascular events europeanpharmaceuticalreview
December 18, 2019
The FDA has approved Vascepa (icosapent ethyl) as a secondary therapy to reduce cardiovascular events in adults.
TransThera Biosciences Announces IND Approval from FDA for Clinical Studies of TT-00920 to Treat Chronic Heart Failure firstwordpharma
December 17, 2019
TransThera Biosciences Co. Ltd, a clinical-stage biotechnology company based in Nanjing, China, announced today that the U.S. Food and Drug Administration (FDA) has granted the company's Investigational New Drug (IND) application for TT-00920, a novel sma
TransThera Biosciences Announces IND Approval from FDA for Clinical Studies of TT-00920 to Treat Chronic Heart Failure prnasia
December 17, 2019
Under this IND, TransThera will initiate a Phase 1 clinical trial to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of TT-00920 in healthy volunteers. The trial is expected to initiate in early 2020.
FDA Approves XCOPRI for Partial-Onset Seizures in Adult Patients americanpharmaceuticalreview
December 17, 2019
The U.S. Food and Drug Administration (FDA) approved XCOPRI (cenobamate) for the treatment of partial-onset seizures in adult patients.
Report links greater generic competition and lower generic drug prices europeanpharmaceuticalreview
December 17, 2019
A new report from the FDA has shown that greater competition among generic drug makers is associated with lower generic drug prices.
FDA grants accelerated approval to first targeted treatment for rare Duchenne muscular dystrophy mutation worldpharmanews
December 17, 2019
The U.S. Food and Drug Administration today granted accelerated approval to Vyondys 53 (golodirsen) injection to treat Duchenne muscular dystrophy (DMD) patients who ...

Previous page 1 2 3 4 5 6 7 8 9 10 ... 366 367 Next page