Regulatory
There is no evidence that the lapses have harmed patients who received Spikevax or clinical trial participants who received investigational shots.
Following a U.S. appeals court decision, the company said it is preparing to divest GRAIL through a third-party sale or capital markets transaction.
A European Medicine Agency panel on Friday reaffirmed its decision not to renew the conditional marketing authorization for GSK’s multiple myeloma drug Blenrep.
President Joe Biden has long promised to stand up to Big Pharma, lower prescription drug prices and limit the power of drugmakers—a pledge he seems intent on keeping.
A week after securing FDA approval, a European Medicines Agency committee has endorsed Vertex and CRISPR Therapeutics’ Casgevy for sickle cell disease and transfusion‑dependent beta thalassemia.
The regulator placed the clinical hold on the Chinese biotech’s trio of CAR-T cell therapy candidates after an inspection of its Durham, North Carolina manufacturing facility.
The Biden administration on Thursday said 48 drugs covered under Medicare’s Part B may be subject to inflation rebates in the first quarter of 2024 under the Inflation Reduction Act.
If approved by the FDA, the MDMA-assisted treatment for individuals with post-traumatic stress disorder would be the first U.S. psychedelic-assisted therapy.
The agency is investigating reports of secondary blood cancers in patients who have received certain CAR T cell therapies, but experts say the risk is low and is outweighed by the terminal nature of some cancers.
The year may be coming to a close, but there’s no holiday break for the FDA, which will release five regulatory verdicts over the next two weeks.
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