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Results For "FDA"

1783 News Found

Ascentage Pharma and Tanner Pharma Group initiate a global innovative named Patient Program
News | July 27, 2022

Ascentage Pharma and Tanner Pharma Group initiate a global innovative named Patient Program

Tanner will be the supplier of olverembatinib to healthcare providers on a named patient basis in countries where the drug is not commercially available.


Sun Pharma and Cosmo announce territory expansion of license and supply agreements for WINLEVI
Supply Chain | July 26, 2022

Sun Pharma and Cosmo announce territory expansion of license and supply agreements for WINLEVI

Sun Pharma will receive from Cassiopea the exclusive right to develop and commercialize WINLEVI in Japan, Australia, New Zealand, Brazil, Mexico and Russia.


Dr. Reddy's announces the first-to-market, OTC launch of Allegra-D in the US market
Drug Approval | July 24, 2022

Dr. Reddy's announces the first-to-market, OTC launch of Allegra-D in the US market

Allegra-D had U.S. retail sales of approximately $45 million as of May 2022 according to IRI.


Syngene reports revenue from operations up 8% in Q1 FY 23
News | July 21, 2022

Syngene reports revenue from operations up 8% in Q1 FY 23

Company raises the annual revenue guidance from mid-teens to high teens


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


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.


Dr. Reddy's Laboratories updates on PAI of formulations facility
Drug Approval | July 08, 2022

Dr. Reddy's Laboratories updates on PAI of formulations facility

The company has been issued a Form 483 with two observations which the company will address within the stipulated timeline.


Novavax aims COVID vaccine on Omicron in Q4
Drug Approval | July 05, 2022

Novavax aims COVID vaccine on Omicron in Q4

The vaccine is under FDA review


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


Akebia Therapeutics regaining rights to Vadadustat in the US, Europe and China
News | July 01, 2022

Akebia Therapeutics regaining rights to Vadadustat in the US, Europe and China

Companies finalize termination with an agreed-upon settlement fee of $55M to be paid to Akebia