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574,782 Results for "food and drug administration fda".
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Press Releases
U.S. Food and Drug Administration (FDA) accepts New Drug Application for elinzanetant
October 9, 2024
·
7 min read
Press Releases
Shorla Oncology Announces U.S. Food and Drug Administration (FDA) Expanded Approval of JYLAMVO™ (methotrexate), an Oncology and Autoimmune Drug for Pediatric Indications
October 29, 2024
·
19 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
·
2 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
·
12 min read
Press Releases
Tonix Pharmaceuticals Announces Submission of the TNX-102 SL New Drug Application (NDA) for Fibromyalgia to the U.S. Food and Drug Administration (FDA)
October 17, 2024
·
11 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
·
12 min read
Press Releases
U.S. Food and Drug Administration (FDA) Grants Prolong Pharmaceuticals FDA Fast Track Designation for Novel Stroke Therapy (PP-007) in HEMERA-1 Clinical Study
October 30, 2024
·
3 min read
FDA
OptMed Inc. receives clearance from the U.S. Food & Drug Administration (FDA) for its 510(k) TearRepair™ Liquid Skin Protectant
October 16, 2024
·
1 min read
Pharm Country
HARMONY BIOSCIENCES RECEIVES U.S. FOOD AND DRUG ADMINISTRATION APPROVAL FOR WAKIX® (PITOLISANT) IN PEDIATRIC PATIENTS WITH NARCOLEPSY
Harmony Biosciences (Nasdaq: HRMY) today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for WAKIX® (pitolisant) tablets for the treatment of excessive daytime sleepiness (EDS) in pediatric patients 6 years of age and older with narcolepsy.
June 24, 2024
·
12 min read
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