The FDA has extended by three months its review of Regeneron Pharmaceuticals’ Biologics License Application (BLA) for its antiviral drug REGEN-COV (casirivimab plus imdevimab) for full approval as a preventive…
A new draft guidance from the FDA calls on sponsors to submit detailed plans for achieving racial/ethnic diversity in their trials as part of their investigational new drug (IND) or…
The FDA’s Center for Drug Evaluation and Research (CDER) yesterday released a Manual of Policies and Procedures (MAPP) document that spells out how the Office of Generic Drugs (OGD) will…
GlaxoSmithKline is buying Sierra Oncology and its investigational cancer drug momelotinib in a $1.9 billion windfall for the San Mateo, Calif.- based biopharmaceutical company. Source: Drug Industry Daily
Two online pharmacies selling stimulant drugs were hit with warning letters from the FDA for unlawfully offering to distribute or dispense stimulants that are Schedule II controlled substances, including amphetamine…
The FDA has cited Clearfield, Utah-based Yusef Manufacturing Laboratories for significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and deemed the company’s products adulterated. Source: Drug…
A $2.1 million gene therapy with the potential to cure beta-thalassemia, a lifelong blood disorder, is worth the price, according to the Institute for Clinical and Economic Review (ICER). Source:…
The FDA’s Office of Prescription Drug Promotion (OPDP) has rapped Bausch Health for making false and misleading claims for its topical psoriasis treatment Duobrii. Source: Drug Industry Daily
Veru has stopped a phase 3 study of its COVID-19 treatment sabizabulin after an interim safety analysis found that the drug overwhelmingly reduced the risk of death by 55 percent…
It’s only Wednesday, but it’s already been an active week for clinical holds and other similar directives from the FDA. Source: Drug Industry Daily