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Results For "approval"

2623 News Found

Piramal Pharma strengthens board by inducting three new board members
People | July 11, 2022

Piramal Pharma strengthens board by inducting three new board members

The appointments will add to the well-diversified experience that currently exists on the PPL board.


Govt introduces 'Draft of New Drugs, Medical Devices and Cosmetics Bill, 2022'
Policy | July 11, 2022

Govt introduces 'Draft of New Drugs, Medical Devices and Cosmetics Bill, 2022'

The Bill aims to amend and consolidate the law relating to the import, manufacture, distribution and sale of drugs, medical devices and cosmetics


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.


US FDA Inspection at Alkem's Indore manufacturing facility
Drug Approval | July 08, 2022

US FDA Inspection at Alkem's Indore manufacturing facility

This GMP and Pre-Approval Inspection is part of the routine business operations and the company shall submit to US FDA within the stipulated timeline


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.


Wacker to expand mRNA-based actives capacity at Halle, Germany
News | July 06, 2022

Wacker to expand mRNA-based actives capacity at Halle, Germany

Company is investing more than €100 million in the expansion of the Halle site


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


Pfizer submits new drug application to the U.S. FDA for Paxlovid
Drug Approval | July 03, 2022

Pfizer submits new drug application to the U.S. FDA for Paxlovid

Submission seeks approval for the treatment of COVID-19 in both vaccinated and unvaccinated individuals at high risk


Ardelyx gets into $20 million financing agreement with HealthCare Royalty Partners
News | July 02, 2022

Ardelyx gets into $20 million financing agreement with HealthCare Royalty Partners

HealthCare Royalty Partners funding supports the ongoing launch of IBSRELA in the United States


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