ALS drug's approval draws cheers from patients, questions from skeptics
A controversial new drug for ALS could add months to patients' lives – if it actually works
FDA
FDA seems poised to approve a new drug for ALS, but does it work?
In March, experts who advise the FDA questioned the efficacy of an experimental new drug for ALS. In September, they voted to approve it anyway.
FDA authorizes first revamp of COVID vaccines to target omicron
The new shots from Moderna and Pfizer-BioNTech target both the original strain of the coronavirus and the omicron BA.4/BA.5 subvariants that most people are catching now.
Millions of Americans will soon be able to buy hearing aids without a prescription
A new FDA rule allows adults with perceived mild to moderate hearing loss to buy hearing aids over the counter. Efforts to make them more affordable and accessible have been in the works for years.
5 things to know about the FDA's flawed approach to accelerated drug approvals
An NPR investigation found stalled confirmatory trials and lax enforcement are plaguing the FDA's accelerated approval of drugs for urgent medical needs.
Drugmakers are slow to prove medicines that got a fast track to market really work
Stalled confirmatory trials and lax enforcement plague the Food and Drug Administration's accelerated approval pathway for pharmaceuticals that target urgent medical needs.
A Skittles lawsuit raises questions over titanium dioxide — a legal food additive
A suit has been filed against the maker of Skittles over titanium dioxide, a color additive that has been on the market for decades but which has been banned in food by European authorities.
FDA temporarily suspends order banning Juul cigarettes
The U.S. federal agency said on Twitter that the stay temporarily suspends the marketing denial order while it conducts further review, but does not rescind it.
FDA says COVID boosters for the fall must target newer omicron types
With immunity waning and the super-contagious omicron family of variants getting better at dodging protection, the Food and Drug Administration decided boosters intended for fall needed an update.
FDA advisers recommend updating COVID booster shots for the fall
The Food and Drug Administration will have to decide the exact recipe, but a combination shot is expected that adds protection against a version of the omicron variant to the original vaccine.