Nephron Pharmaceuticals of South Carolina has issued a voluntary recall of about 2 million doses of its medicines after an FDA inspection found a “lack of assurance of sterility” across…
Bristol Myers Squibb’s blockbuster checkpoint inhibitor Opdivo (nivolumab) snagged approvals for two more indications as add-on therapy for unresectable or metastatic esophageal squamous-cell carcinoma. Source: Drug Industry Daily
Eight years after it shelved darapladib, GSK has sold the failed cardiovascular drug to startup SciNeuro Pharmaceuticals as a potential treatment for Alzheimer’s-associated cognitive decline. Source: Drug Industry Daily
Regeneron Pharmaceuticals announced that it will acquire Sanofi’s stake in the Regeneron- Sanofi collaboration on the cancer drug Libtayo (cemiplimab) for $900 million up front, 11 percent royalties on worldwide…
As of Wednesday night, the Federal Trade Commission (FTC) had received a whopping 24,113 comments in response to its February notice soliciting input on how pharmacy benefit manufacturer (PBM) practices…
The FDA has withdrawn its approval of TG Therapeutics’ flagship lymphoma drug, Ukoniq (umbralisib), citing the possibility of increased risk of death in those taking the drug — and the…
A two-week course of Sage Therapeutics’ investigational antidepressant zuranolone improved symptoms of postpartum depression as quickly as 3 days after initiating treatment, with the benefits sustained up to 45 days,…
In the latest move in the ongoing feud over their cholesterol-fighting monoclonal antibodies, Regeneron has filed a new antitrust suit against Amgen, accusing the drugmaker of carrying out an “unlawful,…