U.S. Food and Drug Administration Press Releases - EIN Presswire

Published on November 19, 2025 - 20:04 GMT

FDA grants accelerated approval to sevabertinib for non-squamous non-small cell lung cancer

On November 19, 2025, the Food and Drug Administration granted accelerated approval to sevabertinib (Hyrnuo, Bayer HealthCare Pharmaceuticals Inc.), a kinase inhibitor, for adults with locally advanced or metastatic, non-squamous non-small cell lung cancer …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 19, 2025 - 20:04 GMT

FDA grants traditional approval to tarlatamab-dlle for extensive stage small cell lung cancer

On November 19, 2025, the Food and Drug Administration granted traditional approval to tarlatamab-dlle (Imdelltra, Amgen Inc.) for adults with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 19, 2025 - 20:04 GMT

Drug Trials Snapshots: MODEYSO

HOW TO USE THIS SNAPSHOT The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “ …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 19, 2025 - 16:19 GMT

Drug Trials Snapshots: ANZUPGO

HOW TO USE THIS SNAPSHOT The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “ …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 19, 2025 - 16:19 GMT

FDA approves selumetinib for adults with neurofibromatosis type 1 with symptomatic, inoperable plexiform neurofibromas

On November 19, 2025, the Food and Drug Administration approved selumetinib (KOSELUGO, AstraZeneca Pharmaceuticals LP) for adults with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). FDA previously approved …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 19, 2025 - 16:19 GMT

Drug Trials Snapshots: SEPHIENCE

HOW TO USE THIS SNAPSHOT The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “ …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 18, 2025 - 21:26 GMT

FDA and MHRA Good Clinical Practice Symposium: Data Integrity in Global Clinical Trials - Tackling Challenging Topics in 2020: 02/...

Date and Time: Thursday, February 13, 2020 8:30 AM -5:30 PM GMT (livestream available on day one only) Friday, February 14, 2020 8:00 AM – 2:00 PM GMT Location: Novotel London West Hotel- 1 Shortlands, Hammersmith, London. W6 8DR, UK Registration: See Good …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 18, 2025 - 21:26 GMT

Public Posting of a Comprehensive Surrogate Endpoint Table for CDER- and CBER-Regulated Products

The public posting of a surrogate endpoint (SE) table for both reasonably likely and validated SEs was mandated by the 21st Century Cures Act of 2016 and was achieved in July 2018. The SE table increases transparency by informing stakeholders about the …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 18, 2025 - 19:14 GMT

FDA approves drug to reduce triglycerides in adults with familial chylomicronemia syndrome

Action Today, the U.S. Food and Drug Administration (FDA) approved Redemplo (plozasiran) as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS). Disease or Condition FCS is a rare genetic disorder that affects …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 18, 2025 - 19:14 GMT

National Drug Code Database Background Information

Search NDC What are the NDC Number and the National Drug Code Directory? Section 510 of the Federal Food, Drug and Cosmetic Act (Act), 21 U.S.C. §360, requires a registered drug establishments to provide the Food and Drug Administration (FDA) with a …

Distribution channels: Healthcare & Pharmaceuticals Industry