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1152 News Found

Zydus receives tentative approval from USFDA for Bosentan tablets for oral suspension
Drug Approval | February 16, 2023

Zydus receives tentative approval from USFDA for Bosentan tablets for oral suspension

Bosentan Tablets for Oral Suspension had annual sales of USD 16 mn in the United States (IQVIA MAT Dec. 2022)


Zydus receives tentative approval from the USFDA for Canagliflozin tablets
Drug Approval | February 16, 2023

Zydus receives tentative approval from the USFDA for Canagliflozin tablets

The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya


NATCO files generic Olaparib Tablets in USA
News | February 14, 2023

NATCO files generic Olaparib Tablets in USA

Olaparib is indicated primarily for certain forms of ovarian, breast, pancreatic, and prostate cancer


Sanofi announces change in R&D leadership
People | February 14, 2023

Sanofi announces change in R&D leadership

Dr. Dietmar Berger, has agreed to take the leadership of the team ad interim


Sun Pharma Announces USFDA Approval for Generic Lenalidomide Capsules
News | February 11, 2023

Sun Pharma Announces USFDA Approval for Generic Lenalidomide Capsules

The respective product approval is based on Revlimid Capsules, 5mg, 10mg, 15mg, 25mg and 2.5mg, 20mg as a reference product


Lupin receives approval from USFDA for Glycopyrrolate Injection USP
News | February 10, 2023

Lupin receives approval from USFDA for Glycopyrrolate Injection USP

The approval for Glycopyrrolate clears the path for more internally manufactured injectable products


USFDA provides exception to Glenmark's Baddi facility
Drug Approval | January 28, 2023

USFDA provides exception to Glenmark's Baddi facility

The company will engage with the agency to resolve the import alert at the earliest.


Granules Pharmaceuticals receives ANDA approval for amphetamine mixed salts ER capsules
Drug Approval | January 25, 2023

Granules Pharmaceuticals receives ANDA approval for amphetamine mixed salts ER capsules

Granules now have a total of 53 ANDA approvals from USFDA


Glenmark launches AKYNZEO I.V. in India
News | January 24, 2023

Glenmark launches AKYNZEO I.V. in India

It is administered as a single infusion 30 minutes prior to the start of each chemotherapy cycle that helps prevent, both, acute and delayed phases of CINV


SK bioscience appoints new executives
People | January 23, 2023

SK bioscience appoints new executives

Two biopharmaceutical experts join SK bioscience to strengthen the future strategies