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Results For "USFDA"

1130 News Found

Briefs: Suven Pharmaceuticals, Remedium Lifecare and Kilitch Drugs India
News | February 24, 2024

Briefs: Suven Pharmaceuticals, Remedium Lifecare and Kilitch Drugs India

Suven Pharmaceuticals’ API and forumulations facilities complete USFDA inspection successfully


Briefs: IOL Chemicals and Pharmaceuticals and Auro Peptides
News | February 20, 2024

Briefs: IOL Chemicals and Pharmaceuticals and Auro Peptides

IOL Chemicals and Pharmaceuticals’ product approved by CDE of NMPA, China


Ascentage Pharma’s Phase III study of Olverembatinib cleared by FDA
Drug Approval | February 14, 2024

Ascentage Pharma’s Phase III study of Olverembatinib cleared by FDA

The US FDA's clearance of the trial marks the first global registrational Phase III trial for olverembatinib in patients with CP-CML to be conducted.


Glenmark partners Pfizer to launch Abrocitinib in India
Drug Approval | February 01, 2024

Glenmark partners Pfizer to launch Abrocitinib in India

Developed by Pfizer, Abrocitinib has received marketing authorization from the Central Drugs Standard Control Organization (CDSCO) in India


Enhertu granted Priority Review in the US for patients with metastatic HER2-positive solid tumours
Drug Approval | January 31, 2024

Enhertu granted Priority Review in the US for patients with metastatic HER2-positive solid tumours

Submission to be reviewed under FDA real-time oncology review and Project Orbis


Shilpa Medicare directed to to pay damage to Celltrion
News | January 25, 2024

Shilpa Medicare directed to to pay damage to Celltrion

The matter of Arbitration between Shilpa Medicare Limited and Celltrion towards supply and distribution agreement


Bayer, Sun Pharma sign marketing and distribution agreement for second brand of Finerenone in India
News | January 17, 2024

Bayer, Sun Pharma sign marketing and distribution agreement for second brand of Finerenone in India

Bayer has granted the non-exclusive rights to Sun Pharma to market and distribute a second brand of Finerenone under the brand name Lyvelsa


Briefs: Venus Remedies and Shivalik Rasayan
News | January 13, 2024

Briefs: Venus Remedies and Shivalik Rasayan

Shivalik Rasayan Limited have successfully submitted USMDF for API " Palbociclib " to USFDA


Lupin launches Varenicline Tablets in US
News | January 11, 2024

Lupin launches Varenicline Tablets in US

Varenicline Tablets (RLD Chantix) had estimated annual sales of US $412 million in the US


Unichem receives ANDA approval for Doxazosin Tablets
Drug Approval | January 11, 2024

Unichem receives ANDA approval for Doxazosin Tablets

Doxazosin tablets are indicated for the treatment of hypertension, to lower blood pressure