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Results For "FDA"

1782 News Found

MIRA Pharmaceuticals announces collaboration with Pharmaseed
News | February 08, 2024

MIRA Pharmaceuticals announces collaboration with Pharmaseed

Studies will Investigate Antidepressant Properties of Ketamir to Position for Initial IND Application in 2024


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


Glenmark, Ichnos Sciences form ‘Ichnos Glenmark Innovation’ for new drug discovery in cancer treatment
News | January 30, 2024

Glenmark, Ichnos Sciences form ‘Ichnos Glenmark Innovation’ for new drug discovery in cancer treatment

This alliance brings together drug innovation capabilities of Glenmark and Ichnos to develop cutting-edge therapies for the treatment of hematological malignancies and solid tumors


Jiangsu Alphamab, 3D Medicines and Glenmark sign license agreement for Envafolimab
News | January 29, 2024

Jiangsu Alphamab, 3D Medicines and Glenmark sign license agreement for Envafolimab

Glenmark will be responsible for further developing, registering, and commercializing Envafolimab in India, Asia Pacific, Middle East and Africa, Russia, CIS, and Latin America


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


Lily announces positive gene therapy result for genetic hearing loss
Diagnostic Center | January 25, 2024

Lily announces positive gene therapy result for genetic hearing loss

Hearing restoration was observed within 30 days of a single administration of AK-OTOF in the initial AK-OTOF-101 study participant


EMA grants ODD to GC Biopharma's treatment for Sanfilippo Syndrome
Drug Approval | January 23, 2024

EMA grants ODD to GC Biopharma's treatment for Sanfilippo Syndrome

GC1130A has previously achieved notable milestones by securing both RPDD and ODD from the U.S. FDA in January 2023


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