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581,570 Results for "food and drug administration fda".
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Press Releases
Bonus Biogroup Announces U.S. Food and Drug Administration (FDA) Clearance of an Investigational New Drug (IND) Application for MesenCure™ Phase III Clinical Study in Respiratory Distress
February 21, 2025
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9 min read
Press Releases
Incyte and Syndax Announce U.S. Food and Drug Administration (FDA) Approval of Niktimvo™ (axatilimab-csfr) 9 mg and 22 mg Vial Sizes
January 15, 2025
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14 min read
Press Releases
U.S. Food and Drug Administration (FDA) accepts New Drug Application for elinzanetant
October 9, 2024
·
7 min read
Biotech Bay
X-Therma Announces XT-Thrive® Drug Master File (DMF) Accepted by U.S. Food and Drug Administration (FDA)
X-Therma Inc , announces that the Food and Drug Administration (FDA) accepted a Drug Master File (DMF) covering its product, XT-Thrive ® .
April 17, 2024
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2 min read
Press Releases
Tempest Granted Fast Track Designation from the U.S. Food and Drug Administration for Amezalpat to Treat Patients with Hepatocellular Carcinoma
February 10, 2025
·
7 min read
Press Releases
Affimed Announces Acimtamig and AlloNK® Combination Granted Regenerative Medicine Advanced Therapy (RMAT) Designation by the U.S. Food and Drug Administration (FDA)
December 6, 2024
·
6 min read
Business
Otsuka and Click Therapeutics Announce the U.S. Food and Drug Administration (FDA) Clearance of Rejoyn
Otsuka Pharmaceutical, Co. Ltd. (Otsuka) and Click Therapeutics, Inc., (Click) announce that the U.S. Food and Drug Administration (FDA) has cleared Rejoyn.
April 1, 2024
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12 min read
FDA
U.S. Food and Drug Administration (FDA) Approves FoundationOne®Liquid CDx as a Companion Diagnostic for AKEEGA® (niraparib and abiraterone acetate) for Patients with BRCA-Positive Metastatic Castration-Resistant Prostate Cancer
Foundation Medicine, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®Liquid CDx to be used as a companion diagnostic for AKEEGA® (niraparib and abiraterone acetate) from Janssen Biotech, Inc.
July 1, 2024
·
6 min read
Pharm Country
HARMONY BIOSCIENCES ACKNOWLEDGES U.S. FOOD & DRUG ADMINISTRATION (FDA) ACTION DENYING THE CITIZEN PETITION FOR WAKIX® (PITOLSIANT)
Harmony Biosciences today announced that the U.S. Food and Drug Administration denied the Citizen Petition filed by a short seller claiming that WAKIX is not safe and effective for the treatment of excessive daytime sleepiness (EDS) and cataplexy in adults with narcolepsy.
June 25, 2024
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12 min read
Press Releases
Savara Initiates Rolling Submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for MOLBREEVI* for the Potential Treatment of Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
December 18, 2024
·
5 min read
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