The study found that just 20% of trials submitted to both the FDA and European Medicines Agency had matching evidence.
With what analysts are calling "strong" data, Amgen plans to file a regulatory submission for Uplizna, currently approved for ...
During the third quarter of fiscal year 2025 ("Q3 FY2025”) and to date in 2025, HeartSciences has seen material progress towards FDA submissions of our products and there have been significant ...
Cameron Hoyler is the general counsel, corporate secretary, and executive vice president of PolarityTE, Inc., a Nasdaq-listed ...
Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the "Company" or "Quoin"), a late clinical-stage specialty pharmaceutical company focused on rare and orphan ...
Despite early success, Verona's lack of specific 2025 guidance and competition from Dupixent and other drugs raise concerns.
Recently announced positive data from pivotal randomized, placebo-controlled phase 3 clinical trial of CAN-2409 in intermediate-to-high risk, ...
Yesterday, the U.S. Food and Drug Administration (FDA) updated its website to provide new information on data integrity concerns relating to ...
The U.S. Food and Drug Administration on Thursday made recommendations to vaccine manufacturers for the virus strains to be ...
Medical Device Network on MSN18h
Nearly a third of FDA medical device adverse event reports filed lateA new study found that 9.1% of medical device AEs were reported to the FDA 180 days later than required over a three-year ...
Phase 1/2 trial evaluating the proprietary combination to be run under CRADA with the National Cancer InstituteSecondVersamune®platform candidate ...
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