The Senate voted 65-27 yesterday evening to pass a continuing resolution that will keep the federal government funded through March 11. Source: Drug Industry Daily

In an unusual move, the FDA has backed off deadlines in a recent draft guidance on Coronavirus Aid, Relief and Economic Security (CARES) Act information reporting after the industry lodged…

Fort Lauderdale, Fla.-based ECI Pharmaceuticals has received a warning letter from the FDA, which said the generic drugmaker incorrectly listed two hormone products on FDA’s Drug Registration and Listing System…

Johnson & Johnson (J&J) has struck a deal with Remix Therapeutics — newly launched in late 2020 — to develop small-molecule therapeutics capable of reprogramming RNA processing for up to…

Merck and Curve Therapeutics have struck a collaboration pact potentially exceeding $1.7 billion to develop drugs for up to five disease targets in oncology and neurology. Source: Drug Industry Daily

Clinical challenges and public health concerns combined to derail an FDA approval for Avenue Therapeutics’ intravenous tramadol for acute pain. Source: Drug Industry Daily

A federal judge has ruled that the government incorrectly threatened AstraZeneca with fines for limiting discounts to the controversial 340B Drug Discount program for safety-net hospitals. Source: Drug Industry Daily

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

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…