Gossamer Bio Submits New Drug Application to U.S. FDA for Seralutinib for the...
SAN DIEGO--(BUSINESS WIRE)--Sep. 23, 2026-- Gossamer Bio, Inc. (Nasdaq: GOSS) (the “Company” or “Gossamer”), a clinical-stage biopharmaceutical company focused on the development and commercialization...
View ArticleElevar Therapeutics Receives FDA Conditional Acceptance of Lyrfigtu as Brand...
Fort Lee, N.J., Sept. 22, 2026 (GLOBE NEWSWIRE) -- Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating...
View ArticleLEO Pharma Announces FDA Acceptance of Dersimelagon NDA with Priority Review
Ballerup, Denmark, September 18, 2026 – LEO Pharma, a global leader in medical dermatology, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and granted Priority...
View ArticleEfzimfotase Alfa Granted Priority Review in the US as Treatment for Patients...
18 September 2026 -- Alexion, AstraZeneca’s Rare Disease’s Biologics License Application (BLA) for efzimfotase alfa has been accepted and granted Priority Review by the US Food and Drug Administration...
View ArticleXenon Announces Azetukalner NDA Submission to FDA for Focal Seizures and...
VANCOUVER, BC and BOSTON, MA, September 17, 2026 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq: XENE), a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical...
View ArticleAquestive Therapeutics Announces Resubmission of New Drug Application to FDA...
WARREN, N.J., Sept. 17, 2026 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful improvement...
View ArticleU.S. FDA Accepts New Drug Application Under Priority Review for Takeda’s...
OSAKA, Japan AND CAMBRIDGE, Massachusetts, September 14, 2026 - Takeda (TSE:4502/NYSE:TAK) announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) under...
View ArticleMonopar Initiates Rolling NDA Submission for ALXN1840 in Wilson Disease
WILMETTE, Ill., July 22, 2026 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (“Monopar” or the “Company”) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company developing innovative treatments for...
View ArticleCeleCor Completes Submission of FDA New Drug Application for Investigational...
DEL MAR, CALIF., USA – June 24, 2026 -- CeleCor Therapeutics has submitted the final section of its New Drug Application for the company’s investigational heart-attack drug, zalunfiban (DisaggproTM),...
View ArticleKowa 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)...
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