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The FTC and the Department of Justice (DOJ) will co-host a Sept. 5 workshop on draft merger guidelines the agencies propose to use when assessing whether a merger may violate antitrust law and stifle competition. Read More
Pfizer announced Monday that it has reopened its Rocky Mount plant and that efforts to restart production are on track to restart production near the end of the year. Read More
HHS this morning released its list of the top 10 drugs for negotiation through the Inflation Reduction Act, a group that represents $50.5 billion in Medicare Part D prescription drug costs — 20 percent of total gross spent between June 1, 2022, and May 31. Read More
Amgen scored a win in its bid to acquire Horizon Therapeutics with the FTC withdrawing from adjudication of its challenge of the deal until Sept. 18, to allow for discussion of a possible settlement. Read More
The FDA’s draft guidance on psychedelic drug trials excludes many nurses from serving as lead and assistant monitors, according to sponsors, nurses and nonprofits amongst the more than 160 comments the agency received. Read More
The FDA is seeking public comment on its decision to withdraw accelerated approval for Oncopeptide’s Pepaxto (melphalan flufenamide), after a required postmarketing study showed that the drug plus dexamethasone failed to improve progression-free survival in patients with relapsed or refractory multiple myeloma. Read More
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on laws and regulations that could impact your business. Read More
As word comes out that the Biden Administration may do a two-days-early reveal on the 10 drugs to be discounted through the Inflation Reduction Act (IRA), another pharma company — AstraZeneca — has filed a lawsuit challenging the IRA. Read More
CVS Health has launched a subsidiary, Cordavis, to work directly with manufacturers to commercialize and/or co-produce FDA-approved biosimilar products at more affordable prices. Read More
The FDA “does not intend” to enforce the Drug Supply Chain Security Act (DSCSA) requirement that manufacturers electronically capture and share data that will track a drug at the individual package level from manufacture to sale until Nov. 27, 2024 the agency announced in a guidance published on Friday. Read More