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In an unusual move, the FDA has backed off deadlines in a recent draft guidance on Coronavirus Aid, Relief and Economic Security (CARES) Act information reporting after the industry lodged several pointed complaints. Read More
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 (eDRLS), and of misbranding. Read More
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 three disease targets in immunology and oncology. Read More
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. Read More
Clinical challenges and public health concerns combined to derail an FDA approval for Avenue Therapeutics’ intravenous tramadol for acute pain. Read More
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. Read More