Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Diffusion, Diverse, Lipocine, Mateon, Organicell.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alume, Ascentage, Aspargo, Combioxin, Cytodyn, Freeline, Genetx, Kala, Kempharm, Marinus, Stallergenes Greer, Tolmar, Ultragenyx.
Citing "known and potential benefits" of using Gilead Sciences Inc.'s remdesivir for the treatment of COVID-19 that "outweigh the known and potential risks of the drug's use," the FDA has issued an emergency use authorization (EUA) for the antiviral, currently in limited supply, according to the company. Gilead CEO Daniel O’Day, who said the company is working with partners across the globe to ramp up supply, said his team is working with "urgency and responsibility" to meet global needs for the medicine.
The EMA's Committee for Medicinal Products for Human Use said Friday it has started a rolling review of Gilead Sciences Inc.'s antiviral, remdesivir, for the potential treatment of COVID-19. The move put into play one of multiple regulatory tools it has deployed "to speed up the assessment of a promising investigational medicine during a public health emergency."
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acceleron, Alexion, BMS, Essa, Galectin, Genmab, Novan, Novartis, Pierre Fabre, PTC, Sosei, Telix, Vertex.
Carmell Therapeutics Corp., of Pittsburgh, received fast track designation from the U.S. FDA for its first product, CT-101, a bone healing accelerant. Carmell is gearing up for a phase III study of the plasma-based bioactive accelerant as part of its pursuit of a biologic license application.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acasti, Akarx, Alpha Cognition, Annovis Bio, Banner Life Sciences, Biocardia, Dova, Galectin, Genmab, Glaxosmithkline, Inmed, Junshi, Marker, Medivir, Neon, Pharming, Seelos, Zentalis.
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