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Search Results for "FDA" (68 articles)
A senior FDA official has expressed skepticism about UniQure's gene therapy for Huntington's disease, stating it has failed to demonstrate effectiveness, requiring further trials to prove its efficacy.
TransMedics Group's medical stock is nearing a buy point due to robust demand for its technology and services, particularly in liver transplants, driven by FDA approval of its Organ Care System platform.
Moderna's stock rises after the FDA announces it will review the company's seasonal flu vaccine candidate, a reversal from its earlier rejection.
The FDA has agreed to review Moderna's mRNA flu vaccine application, paving the way for its potential approval and availability for the upcoming influenza season.
Moderna's stock surged after the FDA agreed to review its flu-vaccine candidate, reversing a previous decision, following concessions made by the company.
Moderna's stock has declined due to the FDA's rejection of its application for a new seasonal flu vaccine, leaving investors puzzled about the reason behind the decision.
Moderna's experimental flu shot, mRNA-1010, has been rejected by the FDA for review, contradicting previous feedback from the regulatory agency.
Hims & Hers Health stock dropped 16% after facing a lawsuit from Novo Nordisk and FDA scrutiny, impacting investor sentiment.
Eli Lilly's weight loss pill is on track for a second-quarter launch in the US, pending FDA approval, with the company expressing optimism about the progress.
ImmunityBio's stock soars after the FDA outlines a resubmission path for ANKTIVA in bladder cancer, indicating a positive development for the company's plans.
ImmunityBio's stock is experiencing a sharp rally after the FDA outlined a resubmission path for its ANKTIVA treatment in bladder cancer, boosting investor sentiment.
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