Britain and Canada have authorized another round of booster shots for older and immunocompromised citizens. So far, U.S. officials haven’t followed suit.
Duodenoscopes — tubular cameras threaded into the intestine — with disposable parts were supposed to be safer. But the parts can fall off in the body, the F.D.A. warned.
The products, which were sold at Trader Joe’s, Costco, Aldi and other retailers, have been linked to five cases of illness, a federal agency said.
While an agency analysis did find signs of Covid “rebound,” the drug significantly reduces hospitalizations and deaths, researchers said.
The first hearing in a lawsuit that seeks to overturn F.D.A. approval of the pills takes place Wednesday morning in Texas.
Pfizer’s treatment applies an approach that is different from some other products, which doctors say may make it safer for people at risk of heart attacks or stroke.
The U.S. agency wants to ensure that doctors inform women that some breast anomalies require more examination.
The F.D.A. seemed poised to rescind approval of Makena, after studies over time indicated the treatment did not halt early childbirth for many women.
The shots, if approved by the agency, would be the first vaccines publicly available against a respiratory virus that kills thousands a year. Some advisers did cite a small but identifiable health risk.
The suit argues that rules applying to mifepristone unnecessarily limit patients’ access to medication abortion.