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 ...
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.
FDA Accepts Astellas Pharma's Revised SNDA For IZERVAY In Geographic Atrophy Treatment
Astellas Pharma Inc. (ALPMY, ALPMY) announced that the U.S. Food and Drug Administration accepted the revised supplemental New Drug ...
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 ...
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 ...
Cristcot‘s Phase III ulcerative colitis suppository trial meets endpoints
The Phase III trial successfully saw patients achieving clinical remission and stopping rectal bleeding within 28 days.
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 ...
JD Supra33m
DOJ Issues Final Rule Restricting Flow of Bulk Sensitive Personal Data to China and Other Countries of Concern
On January 8, 2025, the Department of Justice (“DOJ”) published its Final Rule to implement President Biden’s Executive Order 14117, ...
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FDA Clears PCRX's New Iovera Smart Tip for Expanded Use in Pain Relief
Pacira BioSciences PCRX announced that the FDA has cleared its application to market a new Smart Tip for the iovera system ...
Fujifilm Celebrates 8 New Recipients of Fujifilm Fellowships at Harvard Medical School
Multi-year program advancing translational medical science research and educationCAMBRIDGE, Mass., Jan. 09, 2025 (GLOBE NEWSWIRE) -- FUJIFILM Holdings America Corporation (Fujifilm), today celebrates ...
Johnson & Johnson: Nipocalimab granted U.S. FDA Priority Review for the treatment of generalized myasthenia gravis
Biologics License Application acceptance supported by results from the Phase 3 Vivacity-MG3 study Results demonstrate sustained disease control over 24 weeks in a broad ...