FDA

News

FDA schedules adcomm for Pfizer's COVID booster filing

The FDA will hold an advisory committee meeting later this month to discuss Pfizer and BioNTech's filing for approval of a third booster dose of their COVID-19 vaccine Comirnaty in people a

News

FDA firms up JAK inhibitor warnings after Xeljanz review

The FDA has concluded its safety review of Pfizer's JAK inhibitor Xeljanz and Xeljanz XR, requiring revised warnings for the drugs as well as others in the class after finding evidence of e

News

FDA clears J&J's twice-yearly Invega for schizophrenia

One of the biggest challenges to treating schizophrenia is non-compliance with treatment, but Johnson & Johnson's pharma unit Janssen is trumpeting a new version of its Invega drug that

News

FDA grants full approval to Pfizer/BioNTech COVID jab

Pfizer and BioNTech's COVID-19 vaccine was the first to get emergency use authorisation (EUA) from the FDA, and has also become the first to get full regulatory approval in the US.

News

FDA issues warning on robot-assisted breast cancer surgery

The FDA has issued a safety alert about the use of robot-assisted surgical (RAS) devices for use in mastectomy procedures, pointing out that their safety and efficacy have not been establis

News

Jardiance gets parity with Farxiga in US as FDA clears use i...

Eli Lilly and Boehringer Ingelheim have claimed FDA approval for their diabetes therapy Jardiance in heart failure with reduced ejection fraction (HFreF), setting up a market tussle with As

FDA schedules adcomm for Pfizer's COVID booster filing

FDA firms up JAK inhibitor warnings after Xeljanz review

FDA clears J&J's twice-yearly Invega for schizophrenia

FDA grants full approval to Pfizer/BioNTech COVID jab

FDA issues warning on robot-assisted breast cancer surgery

Jardiance gets parity with Farxiga in US as FDA clears use i...

Delivering the right behavioural ingredients for the moment,...

How to meet your physicians where they are online

FDA

Editor's Picks