On August 8, 2025, the FDA granted accelerated approval to zongertinib for adult patients with unresectable or metastatic ...

The US FDA has approved mosunetuzumab-axgb (Lunsumio VELO) as a subcutaneous formulation for the treatment of adult patients ...

A gene therapy for hearing loss. A drug that helps people quit e-cigarettes or vaping. An anesthetic whose main ingredient will be manufactured in the U.S. These are among the first nine therapies ...

Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and ...

The Food and Drug Administration is investigating whether COVID-19 vaccines caused deaths in adults, as part of a safety review that earlier appeared to just be focused on children. The investigation, ...

Six days after a senior FDA official sent a sweeping internal email claiming that COVID vaccines had caused the deaths of "at ...

The US Food and Drug Administration is changing the way it approves Covid-19 vaccines for Americans, a move that may limit future shots to older Americans and people at higher risk of serious Covid-19 ...

Billions of prescriptions for generic drugs are filled in the U.S. annually. The FDA tests only a few dozen of them every ...

Michael Kaplan is an award-winning reporter and producer for the CBS News investigative unit. He specializes in securing scoops and crafting long-form television investigations. His work has appeared ...

FDA leaders under President Trump are moving to abandon a decades-old policy of asking outside experts to review drug applications, a move critics say would shield the agency's decisions from public ...

Developing high-quality, safe, and effective drugs is a complex process that requires varied scientific skills and stringent regulatory assessments. Drug development is a process that spans many years ...

Empower Pharmacy markets itself as a well-meaning rival to Big Pharma — one that seeks to democratize medicine by making affordable, personalized drugs for patients who need them. As one of an ...