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FDA Delays Decision on Sanofi (SNY)-Regeneron Dupixent in COPD
Zacks via Yahoo Finance· 21 hours agoPer the FDA, the data submitted by Sanofi (SNY)/Regeneron (REGN) for Dupixent in COPD indication...
Moderna Wins FDA Approval For Second-Ever Product; Why Its RSV Vaccine Could Dominate Pfizer, GSK
Investor's Business Daily· 19 hours agoModerna stock sank Friday after the Food and Drug Administrationapproved its RSV vaccine, dubbed...
FDA Approves First Interchangeable Biosimilar for Two Rare Diseases
WLNS Lansing· 4 days agoToday, the U.S. Food and Drug Administration approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) to treat certain rare diseases ...
A day in the sun for a new sunscreen?
Politico· 19 hours agoBut the agency hasn’t approved a new ingredient since 1999, and only one company is close to getting regulators to review its application for a substance long available overseas ...
CorMedix secures supply deal for DefenCath with dialysis provider By Investing.com
Investing.com· 4 days agoCorMedix Inc. (NASDAQ: CRMD), a biopharmaceutical company, has announced a significant commercial...
Moderna wins second product approval with RSV vaccine
Market Watch· 19 hours agoThe FDA’s decision gives Moderna a second approved product at a time when sales of its first product...
FDA approves Amgen’s interchangeable biosimilar Bkemv
Pharmaceutical Technology via Yahoo Finance· 3 days agoAmgen recently announced that the US FDA granted accelerated approval for its IMDELLTRA...
Moderna Receives U.S. FDA Approval for RSV Vaccine mRESVIA(R)
Digital Journal· 19 hours agomRESVIA is Moderna's second approved product and the only RSV vaccine available in single-dose pre-filled syringes CAMBRIDGE, MA / ACCESSWIRE / May 31, ...
JD Supra: FDA Makes Good on Its Promise to Regulate Laboratory-Developed Tests
JD Supra· 15 hours agoYesterday, the Food & Drug Administration (“FDA” or “the Agency”) issued a highly anticipated – and highly controversial – final rule, which rolls out a four-year, five-stage ...
Federal and State Approaches to Therapeutic Cannabis | JD Supra
JD Supra· 3 days agoAt the federal level, the U.S. Food and Drug Administration (FDA) has approved one drug product derived from the cannabis sativa L. plant ...
