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Results For "U.S.-Food-and-Drug-Administration"

594 News Found

APhA appoints Ilisa Bernstein Interim CEO
People | June 06, 2022

APhA appoints Ilisa Bernstein Interim CEO

Dr. Bernstein will tap into her decades of leadership and strategy experience as she transitions into this new role at APhA


Mitsubishi Tanabe Pharma America presents 48-week results from phase 3 safety clinical study of Radicava ORS
News | June 03, 2022

Mitsubishi Tanabe Pharma America presents 48-week results from phase 3 safety clinical study of Radicava ORS

Radicava ORS was approved by the U.S. Food and Drug Administration (FDA) on May 12, 2022


USFDA accepts dupilumab for priority review in adults with prurigo nodularis
Drug Approval | June 01, 2022

USFDA accepts dupilumab for priority review in adults with prurigo nodularis

Dupixent would be the first and only medicine specifically indicated to treat prurigo nodularis in the U.S., if approved


FDA approves Roche’s Evrysdi for use in babies under two months with SMA
Drug Approval | June 01, 2022

FDA approves Roche’s Evrysdi for use in babies under two months with SMA

Evrysdi has proven efficacy in babies, children and adults with more than 5,000 patients treated to date


USFDA approves two Opdivo-based regimens
Biotech | May 29, 2022

USFDA approves two Opdivo-based regimens

Opdivo-based treatments are now approved for five indications in upper gastroesophageal cancers


USFDA approves Omeprazole capsules to prevent heartburn
Drug Approval | May 27, 2022

USFDA approves Omeprazole capsules to prevent heartburn

Perrigo expects to launch Omeprazole Minis later this year


Revolutionary wearable ultrasound device gains USFDA approval
Healthcare | May 27, 2022

Revolutionary wearable ultrasound device gains USFDA approval

Manamed, a pioneering Medical Technology development company, has been granted FDA approval on its latest orthopaedic recovery device, ManaSport.


Dr. Reddy's and Senores Pharmaceuticals launches Ketorolac Tromethamine tablets in the U.S. market
News | May 25, 2022

Dr. Reddy's and Senores Pharmaceuticals launches Ketorolac Tromethamine tablets in the U.S. market

The Toradol tablets, 10 mg brand and generic had U.S. sales of approximately US $ 16.8 million MAT for the most recent twelve months ending in March 2022 according to IQVIA


USFDA approves Dupixent as first treatment for 12 and older with eosinophilic esophagitis
Drug Approval | May 21, 2022

USFDA approves Dupixent as first treatment for 12 and older with eosinophilic esophagitis

Dupixent is the first and only medicine indicated to treat eosinophilic esophagitis in the United States; approval granted more than two months ahead of USFDA’s Priority Review action date


AbbVie submits NDA for treatment of advanced Parkinson’s disease
Biotech | May 21, 2022

AbbVie submits NDA for treatment of advanced Parkinson’s disease

If approved, ABBV-951 will offer patients the first continuous subcutaneous delivery of carbidopa/levodopa prodrugs