INCHEON, Korea & JERSEY CITY, N.J., May 27, 2025--Organon and Samsung Bioepis' HADLIMA granted FDA interchangeability designation approval for all high- and-low concentration presentations.

U.S. Food and Drug Administration. June 2024. 2 Approval letter for HADLIMA (adalimumab-bwwd) supplemental biologics license applications 761059/S-025 and 761059/S-026. U.S. Food and Drug ...

Bi, 69, served as the chief of the China Food and Drug Administration from 2015 to 2018, when he introduced regulatory overhauls that spurred innovation in China’s pharmaceutical sector.

Former FDA commissioner on the Trump administration’s troubled decision to cut staff who were going to help create generic GLP-1s.

Gynecologic cancer (Gyn-Ca) treatment has seen meaningful advancements in therapeutic outcomes in the past decade with the introduction of new therapies. 1-4 Despite this progress, not all populations ...

Savara Receives Refusal to File (RTF) Letter From the U.S. Food and Drug Administration (FDA) for the Biologics License Application (BLA) for MOLBREEVI* to Treat Patients With Autoimmune Pulmonary ...

WEDNESDAY, June 11, 2025 (HealthDay News) — The U.S. Food and Drug Administration (FDA) says it plans to use artificial intelligence (AI) to help speed the approval of new drugs and medical devices.

Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced that the U.S. Food and Drug Administration (FDA) has ...

Drug-induced liver injury cases are increasing, with common medications and supplements posing hidden dangers, especially for vulnerable populations.

A recent cookie recall has escalated, with the U.S. Food and Drug Administration (FDA) now designating it as a Class I recall, which is the highest risk level. This move comes after New Grains ...

The U.S. Food and Drug Administration said on Monday that it had launched a generative AI tool, Elsa, aimed at improving efficiency across its operations, including scientific reviews.