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Johnson & Johnson (J&J) is further curtailing its participation in the controversial 30-year-old 340B Drug Discount Program, which was designed to serve low-income patient populations in the U.S. Read More
The FDA has reclassified ophthalmic drugs packaged with eye cups, eye droppers or other dispensers as “drug-led combination products” rather than just drugs, the agency said in a final guidance. Read More
The FDA’s communications with the biosimilars industry around inspection delays have been “poor,” and its interaction with that sector of the industry around application-level communications and regulatory science hasn’t been much better. Read More
The FDA won’t weigh in on whether Regenxbio may be granted a patent extension for its adeno-associated virus (AAV) technology used to produce Novartis’ blockbuster spinal muscular atrophy (SMA) therapy Zolgensma (onasemnogene abeparvovec). Read More
Bristol Myers Squibb (BMS) is accusing AstraZeneca of infringing on several patents related to its blockbuster cancer immunotherapy Opdivo (nivolumab). Read More
The FDA has issued a warning letter to Boca Raton, Fla.-based Iotech International for making unsupported claims for its antiseptic mouthwash and iodine-containing hand sanitizers. Read More
The European Medicines Agency’s (EMA) safety committee has recommended revised product safety information for Johnson & Johnson’s (J&J) and Moderna’s COVID-19 vaccines. Read More
There’s a push by congressional Democrats to get President Biden to issue a host of executive orders as soon as possible on key priorities, including drug pricing, because they’re not convinced they can get legislation passed before the November midterms. Read More