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599,618 Results for "food and drug law institute".
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Press Releases
CervoMed Announces Orphan Drug Designation Granted to Neflamapimod by U.S. Food and Drug Administration for the Treatment of Frontotemporal Dementia
November 27, 2024
·
6 min read
Press Releases
Alnylam Announces U.S. Food and Drug Administration Acceptance of Supplemental New Drug Application for Vutrisiran for the Treatment of ATTR Amyloidosis with Cardiomyopathy
November 25, 2024
·
8 min read
Policy
BWXT Medical Submits Drug Master File for Actinium-225 API to U.S. Food and Drug Administration
BWXT Medical Ltd. has submitted a Drug Master File to the U.S. Drug and Food Administration for No Carrier Added Actinium-225 Active Pharmaceutical Ingredient.
June 7, 2024
·
3 min read
Press Releases
PharmaTher Receives Complete Response Letter from the U.S. Food and Drug Administration for Ketamine Abbreviated New Drug Application
October 24, 2024
·
4 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
U.S. Food and Drug Administration Grants Regulatory Clearance to IceCure for Next-Gen XSense™ Cryoablation System with CryoProbes
IceCure Medical Ltd. (NASDAQ: ICCM) (“IceCure”, “IceCure Medical” or the “Company”) today announced it has received marketing authorization from the United States Food and Drug Administration (the “FDA”) for its next-generation single probe cryoablation system, the XSense™ Cryoablation System with CryoProbes.
July 1, 2024
·
4 min read
Policy
Genovate Announces Plans to Submit a New Drug Application for PMR to the U.S. Food & Drug Administration in the Second Half of 2025
Genovate Biotechnology Co., Ltd. announced its plans to submit a New Drug Application with the United States Food and Drug Administration for PMR, an investigational once daily extended-release form of cilostazol for the treatment of Intermittent Claudication, in the second half of 2025.
May 28, 2024
·
5 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
U.S. Food and Drug Administration (FDA) accepts New Drug Application for elinzanetant
October 9, 2024
·
7 min read
Press Releases
Abeona Therapeutics® Completes Pz-cel Biologics License Application Resubmission to U.S. Food and Drug Administration
October 29, 2024
·
5 min read
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