All articles tagged with #fda rejection
Originally Published 4 months ago — by statnews.com
Stealth BioTherapeutics disclosed an FDA rejection letter to rally support for its experimental drug for Barth syndrome, a rare disease affecting about 150 people in the U.S., amid ongoing struggles to meet regulatory requirements and concerns over the company's future.
Originally Published 5 months ago — by Investor's Business Daily
Replimune's stock plummeted 77.2% after the FDA unexpectedly rejected its experimental melanoma drug, citing insufficient data from midstage studies, which surprised investors and analysts who had anticipated approval based on positive preliminary results.
Originally Published 6 months ago — by Investor's Business Daily
Shares of Capricor Therapeutics dropped 33% after the FDA rejected its experimental drug deramiocel for treating cardiomyopathy in Duchenne muscular dystrophy, citing insufficient evidence of effectiveness and issues in manufacturing documentation. The company plans to continue testing with upcoming results from ongoing studies that could support future approval efforts.
Originally Published 2 years ago — by NBC News
Maui firefighters recount their efforts to battle the devastating blaze that destroyed the town of Lahaina, Hawaii, facing dangerous conditions and making life-saving decisions. The FDA rejects Neffy, a needle-free alternative to EpiPens, requesting additional data from drugmaker ARS Pharmaceuticals. Ukrainian President Volodymyr Zelenskyy appeals for international support in holding the line against Moscow's aggression. Republican divisions in the House increase the likelihood of a government shutdown. Fans searching for Taylor Swift's unreleased songs encounter glitches on Google. Olive oil prices surge, leading to thefts.