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Results For "FDA"

2194 News Found

Lupin launches Bromfenac Ophthalmic Solution, 0.075% in US
News | February 14, 2024

Lupin launches Bromfenac Ophthalmic Solution, 0.075% in US

Bromfenac Ophthalmic Solution 0.075% (RLD BromSite) had estimated annual sales of USD 15 million in the U.S.


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
Clinical Trials | 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