Pfizer settlement Texas involves $41.5 million over allegations of altered testing methods for an ADHD drug.
Browsing: Regulatory & Approvals
Regulatory updates, drug approvals, submissions, and compliance developments from authorities like FDA, EMA, and others.
Regeneron Eylea HD approvals enhance its market position with two new indications, intensifying competition with Roche’s Vabysmo.
Sarepta FDA warning highlights heart risk in Elevidys therapy, affecting Duchenne muscular dystrophy patients.
Arrowhead FDA approval for Redemplo marks its transition to a commercial-stage company, targeting a rare genetic disorder.
Domestic Generic Drug Fast-Track Review Program aims to expedite approval for drugs made from domestic materials.
Generic mifepristone approval by FDA expands access to abortion care, offering a new option for patients.
FDA warning letters target misleading advertising by Novo Nordisk, Eli Lilly, and Hims, urging improved transparency and compliance.
FDA approves Forzinity for Barth syndrome, affecting 150 people in the U.S., after months of regulatory uncertainty.
Precigen FDA approval for Papzimeos granted without confirmatory trial, benefiting adult patients with recurrent respiratory papillomatosis.
FDA guidance non-opioid pain medicines includes speedy approval pathways to address the opioid crisis with new drug options.