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. Source:…

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…

The FDA’s draft guidance on psychedelic drug trials excludes many nurses from serving as lead and assistant monitors, according to sponsors, nurses and nonprofits amongst the more than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 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…

As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on laws and regulations that could impact your business. Source: Drug Industry Daily

Withings’ Body Scan health station received FDA clearance for its weight-scale style device that provides users a home electrocardiogram (ECG). Source: Drug Industry Daily

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 —…

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. Source: Drug Industry Daily

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…

Over the past week, the FDA issued a draft guidance on product-specific guidances, extended the comment period on a draft guidance for human cellular and gene therapy products, published a…