Key Points Interested in Oculis Holding AG? Here are five stocks we like better. Oculis' Phase 3 DIAMOND trials of OCS-01 in ...
The US Food and Drug Administration (FDA) published the internal checklists its staff reference when reviewing drug and biologics applications to determine whether the submission is complete, or ...
President and CEO Lynn Seely outlined the company’s clinical development priorities, regulatory strategy and manufacturing ...
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FDA accepts IBRX's filing seeking expanded use of bladder cancer therapy
Shares of ImmunityBio IBRX were up 3% in after-market trading yesterday after the company announced that the FDA accepted its regulatory filing seeking to expand the use of its sole marketed drug, ...
When a new drug application (NDA) or biologics license application (BLA) is deemed incomplete by the US Food and Drug Administration (FDA), the agency can decide not to review the application. So when ...
FDA stated that the “proposed data may be capable of supporting the submission and review of an [NDA] under the accelerated approval pathway” for ...
WOBURN, Mass., Feb. 11, 2026 (GLOBE NEWSWIRE) -- Biofrontera Inc. (BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing in the commercialization and development of ...
The Food and Drug Administration (FDA) has issued a Refuse-to-File (RTF) letter to Moderna, Inc. regarding its Biologics License Application (BLA) for the investigational mRNA-based influenza vaccine ...
MIRA trial data demonstrated a 43% response with 120mg SLK, and a 29 ppt delta vs placebo (p < 0.001) at week 12. VELA-1 met all primary and key secondary endpoints with statistical significance ...
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