FDA Related News

Human Drugs

Keytruda+Lenvima Mixed Data in Gastroesophageal Cancer

Merck and Eisai say results from the Phase 3 LEAP-015 trial evaluating Keytruda plus Lenvima in gastroesophageal adenocarcinoma patients missed its en...

Human Drugs

Fast Track for Prostate Cancer Imaging Drug

FDA grants Clarity Pharmaceuticals a fast track designation for 64Cu-SAR-bisPSMA for positron emission tomography imaging prostate cancer lesions in p...

Human Drugs

Caranx Medical PMA for TAVIpilot AI Software

Caranx Medical files a PMA for its TAVIpilot AI Software for real-time intra-operative guidance of transcatheter heart valve implantation.

Human Drugs

FDA Extends Review of Stealth Bio NDA

FDA extends its review of a Stealth BioTherapeutics NDA for elamipretide, a first-in-class mitochondria-targeted therapeutic for treating Barth syndro...

Human Drugs

Orphan Status for Zai Labs Lung Cancer Drug

FDA grants Zai Lab an orphan drug designation to ZL-1310, an antibody-drug conjugate for treating small cell lung cancer.

Continue Strong Compliance, Quality Programs: Attorneys

Three Ropes & Gray attorneys review major FDA-related enforcement cases in 2024 and say it is impossible to predict with certainty the direction the n...

Medical Devices

Implement Digital Technologies Carefully: GE HealthCare

Two medical device stakeholders suggest ways for FDA to regulate generative AI and foundation model-enabled medical devices.

Human Drugs

FDA Will Review Biogen Spinraza sNDA

FDA will review a Biogen sNDA for a Spinraza higher dose regimen.

Human Drugs

FDA Removes Diversity Docs From Web Site

FDA removes information and documents regarding several diversity-related initiatives and policies, presumably in response to a Trump Administration E...

FDA General

Former FDA Womens Health Head Wood Dies

Former FDA associate commissioner for womens health Susan Wood passes away at her home in London after battling glioblastoma (brain cancer).