US FDA declines to approve GSK drugs division’s long acting HIV injection
ViiV, in which Pfizer and Shionogi have small stakes, said it received a so-called complete response letter (CRL) from the FDA in…
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US antitrust enforcers give Roche approval to buy Spark Therapeutics
The FTC approved the deal, which was originally announced in February, without requiring any asset sales to ensure that the…
Roche’s Tecentriq cocktail scores trial success in melanoma
The study met its primary aim of showing progression-free survival in patients with previously untreated BRAF V600…
Sanofi ends research in diabetes, narrows units to spur profit
The French drugmaker, whose pipeline has disappointed investors in recent years, poached new chief executive Paul Hudson from…
Bluebird bio, Bristol-Myers’ multiple myeloma therapy shows promise in early study
The lowest dose of the therapy, bb21217, had a median duration of response of 11.1 months and an overall response rate of 83 per…
US FDA approves generic versions of Novartis blockbuster MS treatment
The approval allows HEC Pharm, Biocon and Sun Pharmaceutical Industries to produce the drug for the treatment of relapsing forms…
FDA declines to approve Enzyvant regenerative therapy on manufacturing concerns
The company was hoping to win its first approval for the therapy, RVT-802, aimed at treating congenital athymia, a disorder…
AstraZeneca-Merck’s Lynparza wins approval in China for ovarian cancer treatment,
The approval in China is based on the results from a late-stage study in which Lynparza lowered the risk of disease progression or…
Sanofi agrees to sell Seprafilm to Baxter for $350 mln: Source
Sanofi took on Seprafilm, which is used to help manage bleeding in abdominal and pelvis operations, in 2011 as part of its…
AstraZeneca’s Imfinzi gets FDA priority review for small cell lung cancer
The company said the FDA accepted its supplemental application and granted priority review to Imfinzi for the treatment of…