Alume Biosciences Gains FDA Breakthrough Therapy Designation for Bevonescein
SAN DIEGO, Calif. — September 25, 2026 Alume Biosciences, Inc. announced that the U.S. Food and Drug Administration (FDA)...
Breakthrough Therapy Designation
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Revolution Medicines Gains FDA Breakthrough Designation for RASONQUE
REDWOOD CITY, Calif. — September 14, 2026 Revolution Medicines, Inc. announced that the U.S. Food and Drug Administration (FDA)...
Definium Therapeutics Gains FDA Breakthrough Therapy Designation for DT120 in MDD
NEW YORK — September 8, 2026 Definium Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted...
InnoCare Secures China Breakthrough Therapy Status for Marginal Zone Lymphoma Therapy
BEIJING, Aug. 4, 2026 InnoCare Pharma announced that the China National Medical Products Administration (NMPA) Center for Drug Evaluation...
Lundbeck Completes Enrollment in Phase III DEEp OCEAN Trial
VALBY, Denmark, July 20, 2026 H. Lundbeck A/S has reached a major clinical development milestone with the last patient...
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Marengo Reports Phase II Breast Cancer Trial Success
CAMBRIDGE, Mass., April 17, 2026 Marengo Therapeutics has unveiled encouraging late-breaking Phase IIa clinical results for its investigational immunotherapy...
Persephoni Backs SelSym to Advance Trauma Bleeding Care
RESEARCH TRIANGLE PARK, N.C., July 15, 2026 Persephoni BioSciences has announced a strategic investment in SelSym Biotech, bringing the...
Genentech Wins FDA Priority Review for Gazyva in pMN
SOUTH SAN FRANCISCO, Calif., July 14, 2026 Genentech, a member of the Roche Group, has received U.S. Food and...
Roche’s Gazyva Receives FDA Priority Review
BASEL, Switzerland, July 15, 2026 Roche announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review...
Dizal Licenses Zegfrovy to AstraZeneca in $1.5B Deal
SHANGHAI, China, July 14, 2026 Dizal has entered into a landmark global exclusive license agreement with AstraZeneca for Zegfrovy...
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