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Mirati Plays Catch-Up With Amgen, Gilead’s 2nd Try With AIDS Drug, Cytokinetics’ Adcom Test And More: Key Nov FDA Decisions For Biotech Investors

Food and Drug Administration decisions and advisory committee verdicts slated for November were mostly positive. New molecular entity approvals so far this year trail 2021’s tally by about 35%.


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AstraZeneca-Merck’s Prostate Cancer Combo Drug, 3rd Try For scPharma, 3 FDA Panel Decisions And More: October’s Key PDUFA Catalysts Biotech Investors Must Know

Most FDA decisions scheduled for September yielded positive results, but there were stray disappointments as well. Seven new molecular entities, or NMEs, were approved during the month, taking the total NME approvals for the year to 24. This is far less than the 40 approvals received by the same time last year.