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569,861 Results for "food and drug administration fda".

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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
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
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
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
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
U.S. Food and Drug Administration (FDA) Has Accepted the New Drug Application (NDA) for Ensartinib

Xcovery Holdings, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for ensartinib, an Anaplastic Lymphoma Kinase (ALK) inhibitor for the treatment of adult patients with metastatic ALK-positive non-small cell lung cancer (NSCLC).

March 13, 2024
·
2 min read
Pharm Country

Curio Digital Therapeutics Inc. Announces the U.S. Food and Drug Administration (FDA) Clearance of MamaLift Plus™, the First Prescription Digital Therapeutic Authorized for the Treatment of Postpartum Depression (PPD)

Curio Digital Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has granted clearance to MamaLift PlusTM.

April 23, 2024
·
7 min read
Genetown

Moderna’s Investigational Therapeutic for Methylmalonic Acidemia (mRNA-3705) Selected by U.S. Food & Drug Administration for START Pilot Program

Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has selected mRNA-3705 for the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) pilot program.

June 6, 2024
·
5 min read
Press Releases

SS Innovations Conducts Interactive Meeting with the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) and Updates its Expected FDA Approval Timeline

September 11, 2024
·
4 min read

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