The FDA is not ruling out further use of remote assessments for Good Clinical Practice (GCP) inspections postpandemic, but the agency is clear: the bulk of its inspection activity will…

The Senate is expected to vote today to end discussion on a continuing resolution that would keep the federal government funded at fiscal 2021 levels beyond Feb. 18. Source: Drug…

The FDA approved 100 abbreviated new drug applications (ANDAs) through its congressionally established Competitive Generic Therapy (CGT) pathway in 2021, bringing 100 new low-priced medicines to the market for originator…

Sage Therapeutics’ investigational antidepressant, zuranolone, posted positive topline results this week in a phase 3 trial showcasing its potential as an add-on therapy co-administered with a range of standard-of-care antidepressants.…

The FDA has issued a warning letter to Indiana Chem-Port, an active pharmaceutical ingredient (API) manufacturer in Gujarat, India, for significant deviations from current good manufacturing (GMP) practices, rendering its…

Johnson & Johnson (J&J), Merck and AstraZeneca are presenting positive phase 3 data supporting drugs for castration-resistant prostate cancer at this week’s meeting of the American Society of Clinical Oncology…

The Institute for Clinical and Economic Review (ICER) has weighed in on Eli Lilly’s type 2 diabetes drug candidate tirzepatide, saying payers should consider broadening coverage to GLP-1 RAs and…

Eli Lilly is picking up ImmunoGen’s camptothecin antibody-drug conjugate (ADC) platform in a $13 million deal that could eventually net ImmunoGen $1.7 billion. Source: Drug Industry Daily

Robert Califf has, at long last, been confirmed as the new commissioner of the FDA, in a close 50-to-46 Senate vote that contrasted with his easy 89-to-4 confirmation vote to…

Six Republican senators including Mike Lee (Utah), Ted Cruz (Tex.) and Rand Paul (Ky.) circulated a “Dear Colleague” letter on Tuesday to other lawmakers, signaling their intention to delay voting…