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 ...
US medical device and in vitro diagnostic sponsors who are using the Food and Drug Administration’s de novo pathway will be able to use the eSTAR filing format at the beginning of 2022. A pilot ...
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 ...
The results seen with Foundayo, also known as orforglipron, enabled Lilly’s late-stage Achieve-4 study to hit its primary ...
Sanofi SNY announced that the FDA has accepted a regulatory filing seeking to expand the use of its type 1 diabetes (T1D) drug, Tzield (teplizumab), in individuals aged one year and older. The agency ...
WOBURN, Mass., Feb. 11, 2026 (GLOBE NEWSWIRE) -- Biofrontera Inc. (BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing in the commercialization and development of ...
Morning Overview on MSN
IDEAYA-Servier eye cancer drug hits trial goal, clearing path to FDA filing
A closely watched clinical trial testing a new two-drug combination against metastatic uveal melanoma, the deadliest form of ...
Shares of Pacira BioSciences (NASDAQ:PCRX) fell on Tuesday after the company announced that a subsidiary of a Chinese drugmaker has filed a marketing application seeking U.S. approval of a generic ...
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