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FDA Issues Final Rule Regulating Many Laboratory-Developed Tests as Medical Devices
The National Law Review· 4 days agoOn April 29, 2024, the US Food and Drug Administration (FDA) issued the long-awaited final rule...
Earnings call: NovoCure reports growth and clinical advances in Q1 2024 By Investing.com
Investing.com· 2 days agoThe company reported a 13% year-over-year increase in net revenues to $139 million and an 11%...
MannKind Announces IND Clearance From U.S. FDA to Start Phase 3 Study of Clofazimine Inhalation...
Benzinga· 6 days agoand devices for patients with endocrine and orphan lung diseases, announced today that the U.S. Food and Drug Administration (
Press Release: Rilzabrutinib LUNA 3 phase 3 study met primary endpoint in immune thrombocytopenia
Morningstar· 2 weeks agoRilzabrutinib LUNA 3 phase 3 study met primary endpoint in immune thrombocytopenia Pivotal data from the first phase
Is the FDA Pausing More Cancer Trials? It's Hard to Tell
Medscape· 2 weeks agoIs the FDA Pressing Pause on More Cancer Trials? In October, the US Food and Drug Administration (...
FDA Finalizes LDT Regulation, with Significant Exceptions: Enforcement of Requirements Will Phase In...
JD Supra· 3 days agoOn April 29, 2024, the Office of the Federal Register placed on display the Food and Drug Administration’s (FDA) final rule on the regulation of laboratory ...
FDA brings lab tests under federal oversight in bid to improve accuracy and safety
Associated Press via Yahoo News· 6 days agoThe regulation finalized Monday by the Food and Drug Administration will gradually phase in...
FDA Makes Good on Its Promise to Regulate Laboratory-Developed Tests
The National Law Review· 4 days agoYesterday, the Food & Drug Administration (“FDA” or “the Agency”) issued a highly anticipated – and...
NKGen Biotech gears up for Parkinson's trial after FDA nod By Investing.com
Investing.com· 6 days ago(NASDAQ: NKGN), a clinical-stage biotech company, has received clearance from the U.S. Food and Drug...
HOOKIPA advances HPV cancer trial with FDA nod By Investing.com
Investing.com· 1 week ago(NASDAQ: HOOK), a clinical-stage biopharmaceutical company, has announced the final design for its ...