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FDA Accepts Agios' sNDA for Pyrukynd in Thalassemia
Agios Pharmaceuticals AGIO announced that the FDA has accepted its supplemental new drug application (sNDA) seeking label ...
Lundbeck's Appreciation Potential Is Closely Tied To A High-Risk Clinical Pipeline (Rating Upgrade)
Lundbeck’s drug portfolio faces patent expirations but shows growth potential. Find out why HLBBF stock could see upside with ...
The Financial Express7h
USFDA gives nod to Lupin’s generic formulation to treat eye issues
Loteprednol Etabonate Ophthalmic Gel, 0.38% (RLD Lotemax SM) had an estimated annual sale of USD 36 million in the U.S.
Pharmabiz9h
US FDA clears Solid Biosciences’ IND application for SGT-212 to treat neurologic & cardiac manifestations of Friedreich’s ataxia
Charlestown, Massachusetts Thursday, January 9, 2025, 14:30 Hrs [IST] ...
AMD invests $20M in AI-powered drug discovery company Absci
Absci will use AMD’s $20 million investment to enhance its AI models. In parallel, the companies will collaborate to develop ...
Vanda asserts FDA review of tradipitant was flawed
Vanda (VNDA) has written a letter to FDA Commissioner Robert Califf asserting that the review of the market application for ...
Zymeworks Inc.: Zymeworks Outlines Strategic Priorities and Outlook for 2025 and 2026
Investigational new drug (IND) applications for initiating first-in-human studies for ZW220 and ZW251 in solid tumors anticipated in 2025IND applications for initiating first-in-human studies for ZW20 ...
JD Supra23h
Balancing Safety and Accessibility: FDA Broadens Approval Pathway for Nonprescription Drugs by Finalizing the ‘ACNU’ Rule
The US Food and Drug Administration (FDA) has announced a final rule expanding the approval pathway for nonprescription drug ...
Targeted Oncology23h
FDA Clears Investigational New Drug Application for REC-4539 in SCLC
The FDA cleared the investigational new drug application for REC-4539, allowing for the start of a phase 1/2 trial in small ...