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Merck is the latest big drugmaker to announce that it will stop sales of 340B-discounted products to contract pharmacies, ignoring warnings from HHS that such moves made by other drugmakers are in violation of federal law. Read More
Other insurers, including UnitedHealth, say they are waiting for a review of coverage by the Centers for Medicare and Medicaid Services before reaching their decision. Read More
The FDA is asking for public comments on how it regulates generic drugs that were approved prior to the Hatch-Waxman Amendments of 1984, which established the current abbreviated new drug application (ANDA) process for generics. Read More
Less than two weeks after abruptly withdrawing a notice announcing a double-digit increase in user fees for drugmakers under the Prescription Drug User Fee Act (PDUFA), the FDA has issued the notice with reductions in the proposed fees. Read More
An advisory panel assembled by the Centers for Disease Control and Prevention (CDC) voted unanimously on Friday to endorse the FDA’s expanded Emergency Use Authorizations allowing a third dose of the Pfizer/BioNTech and Moderna COVID-19 vaccines for certain immunocompromised individuals. Read More
The UK has ordered an additional 35 million booster doses of the Pfizer/BioNTech COVID-19 vaccine after Pfizer raised the costs due to rising demand. Read More
The FDA has approved the combination of Merck’s Keytruda (pembrolizumab) and Eisai’s Lenvima (lenvatinib) for the first-line treatment of adult patients with advanced renal cell carcinoma, the companies announced late Wednesday. Read More
President Biden yesterday outlined his plan to lower prescription drug prices, calling on Congress to pass legislation enabling Medicare to directly negotiate prices. Read More
The quality management system should, among other things, ensure compliance with good laboratory practice, good clinical practice, and good storage and distribution practices, the WHO says. Read More