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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.

ALNY

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Attention Biotech Investors: Mark Your Calendar For These June PDUFA Dates

May turned out to be a month of mixed fortunes as far as regulatory reviews are concerned. New molecular entity approvals, an indicator of innovation in drug research, totaled three during the month, bringing the total for the year to 15. This compares to the 24 NMEs the Food and Drug Administration approved by May 2021.

ACAD