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Results For "USFDA"

1404 News Found

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


Strides receives USFDA approval for Ibuprofen Oral Suspension
Drug Approval | May 30, 2022

Strides receives USFDA approval for Ibuprofen Oral Suspension

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Motrin Oral Suspension, 100 mg/5 mL, of McNeil Consumer Healthcare (McNeil)


Zydus receives EIR from USFDA for its injectables manufacturing facility at Jarod
Biotech | May 29, 2022

Zydus receives EIR from USFDA for its injectables manufacturing facility at Jarod

The inspection was a Pre-Approval cum cGMP inspection and it covered 15 ANDAs


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 Novartis Kymriah CAR-T cell therapy
Biotech | May 29, 2022

USFDA approves Novartis Kymriah CAR-T cell therapy

68% of patients receiving Kymriah in the ELARA trial experienced a complete response, with an 86% overall response rate, along with a remarkable safety profile


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.


Eugia Pharma receives USFDA approval for Pemetrexed
Drug Approval | May 26, 2022

Eugia Pharma receives USFDA approval for Pemetrexed

Pemetrexed for injection is indicated for the treatment of Antineoplastics (medications used to treat cancer)


Zydus Lifesciences receives final approval from USFDA for Pemetrexed for Injection
Drug Approval | May 26, 2022

Zydus Lifesciences receives final approval from USFDA for Pemetrexed for Injection

Pemetrexed for Injection has a market size of USD 1,236 mn (as per IQVIA MAT March’22)


Alembic Pharmaceuticals receives USFDA final approval for Pirfenidone tablets
Drug Approval | May 24, 2022

Alembic Pharmaceuticals receives USFDA final approval for Pirfenidone tablets

The tablets have an estimated market size of US $ 548 million for twelve months ending December 2021 according to IQVIA