Kowa Pharmaceuticals America Announces FDA Acceptance of New Drug Application...
Montgomery, AL, August 27, 2026 – Kowa Pharmaceuticals America, Inc. (KPA), today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for...
View ArticleNicox’s NCX 470 New Drug Application Submitted in the United States by Kowa
Sophia Antipolis, France July 1, 2026 -- Nicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced the submission of an NDA to the FDA for NCX 470...
View ArticleUS FDA Decision Date Extended for SERENA-6 filing of Camizestrant to Enable...
May 27, 2026 -- The US Food and Drug Administration (FDA) has informed AstraZeneca that it will extend the Prescription Drug User Fee Act (PDUFA) date to review additional data requested to support the...
View ArticleCapricor Therapeutics Announces Extension of PDUFA Target Action Date as FDA...
SAN DIEGO, Aug. 24, 2026 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare...
View ArticleUnited Therapeutics Corporation Announces FDA Filing Acceptance of New Drug...
SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE) August 24, 2026 -- United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that the FDA has...
View ArticleXspray Pharma receives Complete Response Letter (CRL) from FDA for Dasynoc
August 19, 2026 -- The FDA’s Complete Response Letter relates to the previously communicated observations at NerPharMa, concerning outstanding GMP (Good Manufacturing Practice) observations, as well as...
View ArticleBeren Therapeutics Announces FDA Extension of Review Period for New Drug...
THOUSAND OAKS, Calif. – May 28, 2026 – Beren Therapeutics P.B.C.®, the parent company of Mandos LLC® and a leader in cholesterol trafficking biology and cyclodextrin-based therapeutics, announced that...
View ArticleU.S. FDA Accepts Teva’s New Drug Application (NDA) and Grants Priority Review...
PARSIPPANY, N.J. and TEL AVIV, Israel, Aug. 19, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the...
View ArticleBelite Bio Announces U.S. Food and Drug Administration Acceptance and...
SAN DIEGO, Aug. 11, 2026 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE) (“Belite Bio®” or the “Company”), a clinical-stage drug development company focused on advancing novel therapeutics targeting...
View ArticleScholar Rock Announces FDA Review of Apitegromab Biologics License...
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Aug. 7, 2026-- Scholar Rock (NASDAQ: SRRK), a global biopharmaceutical company dedicated to improving the lives of patients with rare, severe, and debilitating...
View ArticleSaol Therapeutics Announces the Acceptance of Resubmission of SL1009 (DCA) by...
ROSWELL, Ga., DUBLIN and HAMILTON, Bermuda, July 28, 2026 — Saol Therapeutics, a privately held, clinical-stage pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA)...
View ArticleRevolution Medicines’ New Drug Application for Daraxonrasib Accepted for...
REDWOOD CITY, Calif., July 22, 2026 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted...
View ArticleBridgeBio Announces FDA Acceptance of NDA for Encaleret for ADH1
PALO ALTO, Calif., July 22, 2026 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage, multi-product biopharmaceutical company focused on...
View ArticleCamurus’ NDA Resubmission for CAM2029 in Acromegaly Accepted for Review by...
Lund, Sweden — 17 July 2026 — Camurus (NASDAQ STO: CAMX) today announced that the US Food and Drug Administration (FDA) has accepted for review the resubmission of the New Drug Application (NDA) for...
View ArticleAxsome Therapeutics Announces FDA Acceptance of New Drug Application for...
NEW YORK, July 15, 2026 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today...
View ArticleApnimed Announces FDA Acceptance of New Drug Application for AD109, An...
CAMBRIDGE, Mass., July 14, 2026 – Apnimed, Inc., a late stage clinical pharmaceutical company dedicated to the discovery, development, and commercialization of novel oral therapies that address the...
View ArticleU.S. Food and Drug Administration Accepts Bristol Myers Squibb's New Drug...
PRINCETON, N.J.--(BUSINESS WIRE) July 13, 2026-- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for...
View ArticleElevar Therapeutics Receives FDA Complete Response Letter for Combination of...
Fort Lee, N.J., July 10, 2026 – Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and...
View ArticleImmunome Announces U.S. FDA Acceptance of New Drug Application for...
BOTHELL, Wash. July 8, 2026 – Immunome, Inc. (Nasdaq: IMNM), a biotechnology company committed to developing first-in-class and best-in-class targeted cancer therapies, today announced the U.S. Food...
View ArticleSaol Therapeutics Resubmits the New Drug Application for SL1009 (DCA) for the...
ROSWELL, Ga., DUBLIN and HAMILTON, Bermuda — July 7, 2026 — Saol Therapeutics, a privately held, clinical-stage pharmaceutical company, today announced the resubmission of its New Drug Application...
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