FDA Selects Seven Firms for PreCheck Manufacturing Pilot
SILVER SPRING, Md., June 29, 2026 The U.S. Food and Drug Administration (FDA) has announced the selection of seven...
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BridgeBio Reports Positive Phase 3 Oral Infigratinib Results for Achondroplasia
PALO ALTO, Calif., June 28, 2026 BridgeBio Pharma announced that positive results from its pivotal Phase 3 PROPEL 3...
Corcept Resubmits Relacorilant NDA for Cushing’s Syndrome to FDA
REDWOOD CITY, Calif., June 17, 2026 Corcept Therapeutics Incorporated announced the resubmission of its New Drug Application (NDA) to...
Disc Medicine Shares FDA Meeting Outcomes for Bitopertin
WATERTOWN, Massachusetts, June 9, 2026 Disc Medicine announced a regulatory update following a Type A meeting with the U.S....
LENZ Therapeutics and Everest Medicines Partner to Advance VIZZ in Greater China
SAN DIEGO, June 7, 2026 LENZ Therapeutics announced that Everest Medicines has acquired the rights to develop, manufacture, and...
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FDA Grants Priority Review to Zydus Therapeutics’ Saroglitazar for Rare Liver Disease
PENNINGTON, New Jersey and AHMEDABAD, India, May 28, 2026 Zydus Therapeutics, a wholly owned subsidiary of Zydus Lifesciences, has...
Achieve Life Sciences Reports 52-Week Safety Data for Cytisinicline
SEATTLE and VANCOUVER, British Columbia, May 19, 2026 Achieve Life Sciences announced positive long-term safety data from the ORCA-OL...
Chiesi to Acquire KalVista in $1.9B Rare Disease Deal
PARMA, ITALY & FRAMINGHAM, MASSACHUSETTS, April 29, 2026 Chiesi Group has announced a definitive agreement to acquire KalVista Pharmaceuticals...
IDEAYA Advances NDA for Darovasertib Under FDA RTOR
SOUTH SAN FRANCISCO, CALIFORNIA, April 30, 2026 IDEAYA Biosciences has announced that the U.S. Food and Drug Administration (FDA)...
Teva Pharmaceutical Acquires Emalex to Advance Tourette Therapy
PARSIPPANY, NEW JERSEY & CHICAGO, April 29, 2026 Teva Pharmaceutical Industries Ltd. has announced a definitive agreement to acquire...
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