Regulatory Affairs

Madrid, Spain – October 11, 2025 – AstraZeneca presented groundbreaking clinical trial results from four major Phase III studies...

North Chicago, Ill., September 26, 2025 – AbbVie (NYSE: ABBV) announced the submission of a New Drug Application (NDA)...

SHANGHAI, China & JERSEY CITY, NJ – September 19, 2025, Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN)...

HORSHAM, Pa., Sept. 19, 2025 — Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food and Drug...

Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for HERNEXEOS®...

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AliveDx, a global in-vitro diagnostics innovator, today announced it has submitted a 510(k) premarket notification to the U.S. Food...