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United States - Healthcare - What You Should Know About The FDA s New Final Rule On LDTs

On May 6, 2024, the FDA published its highly anticipated final rule, which was formally published in the Federal Register on May 6, revising the regulatory definition of an IVD product to explicitly capture IVDs manufactured by laboratories.

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PTC Therapeutics Announces FDA Acceptance and Priority Review of the BLA for Upstaza™

PTC Therapeutics Announces FDA Acceptance and Priority Review of the BLA for Upstaza™
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Pfizer,Genmab: FDA Grants Full Approval For TIVDAK To Treat Recurrent Or Metastatic Cervical Cancer

Pfizer,Genmab: FDA Grants Full Approval For TIVDAK To Treat Recurrent Or Metastatic Cervical Cancer
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PTC Therapeutics Provides Corporate Update and Reports First Quarter 2024 Financial Results

PTC Therapeutics Provides Corporate Update and Reports First Quarter 2024 Financial Results
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United statesKylie okeefeMatthew kleinJeanine clementeEuropean medicines agencyEuropean commissionDrug administrationCommittee for medicinal products human useTherapeutics incProvides corporate updateReports first quarterChief executive officerCorporate updatesRegulatory milestonesGenerally accepted accounting principlesFull year

PTC Therapeutics Provides Corporate Update and Reports Fourth Quarter and Full Year 2023 Financial Results

PTC Therapeutics Provides Corporate Update and Reports Fourth Quarter and Full Year 2023 Financial Results
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United statesKylie okeefeMatthew kleinJeanine clementeAgilis biotherapeutics incEuropean commissionCommittee for medicinal products human useDrug administrationCompany blackstone credit agreementTherapeutics incChief executive officerCorporate updatesRegulatory milestonesFull yearGenerally accepted accounting principlesBlackstone credit agreement