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Results For "Food-and-Drug-Administration"

1021 News Found

Zydus receives final approval from the USFDA for Efinaconazole Topical Solution
Drug Approval | July 18, 2022

Zydus receives final approval from the USFDA for Efinaconazole Topical Solution

Jublia (Efinaconazole) topical solution, 10% had annual sales of $292 million in the United States according to IQVIA data (IQVIA MAT May 2022).


Sumitomo Pharma Oncology receives Orphan Drug Designation for DSP-0390 for the treatment of brain cancer
News | July 18, 2022

Sumitomo Pharma Oncology receives Orphan Drug Designation for DSP-0390 for the treatment of brain cancer

The FDA's Orphan Drug Designation is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people


Enveda appoints Vanitha Sekar as Chief Business Officer
People | July 16, 2022

Enveda appoints Vanitha Sekar as Chief Business Officer

She joins Enveda from Gilead Sciences


U.S. FDA grants emergency use authorization for Novavax COVID-19 vaccine
Drug Approval | July 15, 2022

U.S. FDA grants emergency use authorization for Novavax COVID-19 vaccine

Novavax' vaccine is the first protein-based COVID-19 vaccine authorized in the U.S.


Zydus gets USFDA’s approval for Empagliflozin, Metformin Hydrochloride tablets
Drug Approval | July 12, 2022

Zydus gets USFDA’s approval for Empagliflozin, Metformin Hydrochloride tablets

Empagliflozin and Metformin Hydrochloride tablets are used with proper diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.


Dr. Reddy's Labs launches Fesoterodine Fumarate tablets in US
Drug Approval | July 10, 2022

Dr. Reddy's Labs launches Fesoterodine Fumarate tablets in US

Dr. Reddy's Fesoterodine Fumarate Extended-Release Tablets are available in 4 mg and 8 mg Tablets, each in bottle count sizes of 30.


Lupin’s Somerset manufacturing plant Receives EIR from US FDA
Drug Approval | July 08, 2022

Lupin’s Somerset manufacturing plant Receives EIR from US FDA

The US FDA has determined that the inspection classification of the facility is Voluntary Action Indicated


Cipla updates on US FDA product-specific pre-approval inspection
News | July 06, 2022

Cipla updates on US FDA product-specific pre-approval inspection

The company has received 2 observations on FDA Form 483 with respect to ANDA filed for the product to be manufactured at Indore plant.


Sanofi flu vaccines licensed and approved for 2022-2023 influenza season
Drug Approval | July 05, 2022

Sanofi flu vaccines licensed and approved for 2022-2023 influenza season

Sanofi will begin to ship their vaccines helping to ensure more people will be immunized


OliX Pharmaceuticals submits application to U.S. FDA to evaluate safety and tolerability of OLX10212
Drug Approval | July 04, 2022

OliX Pharmaceuticals submits application to U.S. FDA to evaluate safety and tolerability of OLX10212

The objective of this Phase 1 study is to determine the safety and tolerability of OLX10212 in patients with advanced AMD at multiple sites in the US.