Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 69

Results For "Food-and-Drug-Administration"

1021 News Found

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.


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)


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


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