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Results For "USFDA"

1134 News Found

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


Glenmark Pharma gets observations from USFDA for its Goa and Monroe facilities
News | May 22, 2022

Glenmark Pharma gets observations from USFDA for its Goa and Monroe facilities

A total of five observations for Goa and 17 for Monroe


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


USFDA urges drug manufacturers to develop risk management plans to promote a stronger, resilient drug supply chain
Supply Chain | May 20, 2022

USFDA urges drug manufacturers to develop risk management plans to promote a stronger, resilient drug supply chain

Risk management plans can serve as a safeguard, helping manufacturers prepare for and respond to hazards that could lead to drug supply disruptions and shortages