Ergebnisse des Dosis-Eskalationsteils der klinischen Phase-1-Studie mit ISB 2001 bei Patienten mit stark vorbehandeltem multiplem Myelom wer...

Michael Rogers had worked for the FDA for more than three decades.

SAN FRANCISCO and SUZHOU, China, May 5, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceu...

Atzumi combines a proprietary advanced powder and device technology to simplify nasal delivery of dihydroergotamine for acute treatment of m...

SHANGHAI, May 4, 2025 /PRNewswire/ -- On April 23, 2025, Nutshell Therapeutics ( Shanghai ) Co., LTD. received IND clearance from the FDA to...

PIC's gene-edited pigs are highly resistant to one of the most harmful viruses affecting pig populations worldwide today.

The FDA has rehired at least some workers tasked with releasing public records generated by the agency’s regulatory activities, two employee...

Milk not declared as an allergen was found in a Tennessee-based manufacturer's confectionery, not the first time candy has been recalled in...

JHVEPhoto FDA headquarters in Washington. The study found that more than 1 in 10 women who use mifepristone experience adverse sid...

The US Food and Drug Administration has approved nipocalimab-aahu, a new FcRn- blocking monoclonal antibody, for the treatment of generalize...

FDA Commissioner Dr. Marty Makary said there is a "void of data" on the COVID booster shots.

Some FDA scientists and inspections staff were told that their layoffs may be rescinded.

In a phase 3 trial, 81% of wounds treated with autologous cell sheet-based gene therapy showed ≥ 50% healing at 6 months, compared with 16%...

This is the first and only oral JAK inhibitor indicated for giant cell arteritis, according to the manufacturer AbbVie. Medscape Medical...

By LAURAN NEERGAARD and MATTHEW PERRONEWASHINGTON (AP) — The Trump administration’s effort to impose new requirements on Novavax’s COVID-19...