A controversial new drug for ALS could add months to patients' lives – if it actually works
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.
Birth control pills are available in the U.S. only with a prescription. Now a drugmaker is asking the FDA to approve a progestin-only contraceptive that would be available without one at pharmacies.
The Food and Drug Administration this week approved an injectable drug that helps prevent the spread of HIV. It only has to be taken once every eight weeks, compared to a daily oral pill.
The abortion pill mifepristone was approved in 2000 but still faces layers of restrictions. Advocates want the FDA to permanently allow patients to receive the pill by mail instead of in person.
A panel of independent advisers to the Food and Drug Administration is recommending that the agency issue emergency use authorization for the Pfizer-BioNTech vaccine in children ages 5 to 11 years old.
Dr. Janet Woodcock, an administrative veteran of the Food and Drug Administration since the 1980s, has been acting director of the agency since January. Why is the permanent job so hard to fill?
Plenty of evidence exists supporting vaccination mandates in schools, workplaces and health care settings, doctors with Emory University School of Medicine said this week after full approval came from the U.S. Food and Drug Administration for Pfizer-BioNTech’s COVID-19 vaccine.
The FDA announced the Pfizer vaccine is the first in the U.S. that is now fully approved. Here's what that means for vaccine mandates and convincing vaccine-hesitant people to get vaccinated.
The Pfizer mRNA vaccine is now not only safe and effective against COVID-19 serious illness and death: It’s also fully FDA approved.
Dr. Cecil Bennett of Newnan says the most important thing is to listen to patients who have not yet been vaccinated and try to understand their concerns.
A COVID-19 vaccine for children younger than 12 is not yet available, but research is well underway and the first shot for some kids in this age group is expected in the fall, doctors say.
When a new drug is up for FDA approval, trials may be held not only in the U.S. but other countries too. A study looks at global availability after approval. Big Pharma disagrees with the findings.