Polpharma Biologics Secures FDA and EMA Review for PB016
ROTKREUZ, Switzerland, July 31, 2026 Polpharma Biologics International AG announced that the U.S. Food and Drug Administration (FDA) and...
Ulcerative Colitis
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Abivax Aligns with FDA on Obefazimod NDA Submission
PARIS, France, July 30, 2026 Abivax SA announced the successful completion of a positive pre-New Drug Application (pre-NDA) interaction...
Caldera, Synlogic Unite in $278M Biotech Merger
CAMBRIDGE, Mass., July 29, 2026 Synlogic, Inc. and Caldera Therapeutics, Inc. have entered into a definitive all-stock merger agreement...
NextCure and Avere Strengthen Oral IL-23 Development
SAN FRANCISCO, July 14, 2026 NextCure and privately held Avere Therapeutics have entered into a definitive all-stock merger agreement...
Palisade Bio Receives FDA IND Clearance for PALI-2108
DENVER, Colo., June 29, 2026 Palisade Bio, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared...
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Abivax Reports Positive Phase 3 Obefazimod Maintenance Data
PARIS, France, June 29, 2026 Abivax SA announced positive topline results from ABTECT Maintenance Part 2, the supplemental portion...
cAMPfield Launches With $180M to Advance Oral IBD Therapy
SAN DIEGO, Calif., June 20, 2026 cAMPfield Therapeutics has officially emerged from stealth with a $180 million Series A...
Samsung Bioepis and Organon Expand PYZCHIVA Rights in Canada
INCHEON, South Korea & KIRKLAND, Quebec, Canada, June 18, 2026 Samsung Bioepis and Organon have expanded their long-standing biosimilar...
Takeda’s ENTYVIO Nears Pediatric IBD FDA Approval
OSAKA, Japan and CAMBRIDGE, Massachusetts, June 9, 2026 Takeda has reached a significant regulatory milestone with the U.S. Food...
Mabwell Receives NMPA Clearance for 9MW5211 in Inflammatory Bowel Disease
SHANGHAI, China, June 5, 2026 Mabwell announced that China’s National Medical Products Administration (NMPA) has granted Investigational New Drug...
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