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U S FDA Approves Pfizer s BEQVEZ™ (fidanacogene elaparvovec-dzkt), a One-Time Gene Therapy for Adults with Hemophilia B

A one-time dose of BEQVEZ has reduced bleeds post-treatment compared to standard of care with a median of zero bleeds after up to three years of follow-up, providing sustained bleed protection and.

United statesAdam cukerThromb haemostKim phelanAamir malikDrug administrationPfizer incHemophilia thrombosis programValue healthEuropean medicines agencyExchange commissionCoalition for hemophiliab weCenters for diseaseWorld federation of hemophiliaPenn comprehensiveHemophilia thrombosis

BridgeBio Pharma Announces U S Food and Drug Administration (FDA) Acceptance of New Drug Application (NDA) for Acoramidis for the Treatment of Patients with Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

ATTRibute-CM results also demonstrated rapid clinical benefit on the composite endpoint of all-cause mortality (ACM) and CVH in patients treated with acoramidis, with time-to-first event Kaplan-Meier curves separating at month 3 and continuing to diverge steadily through Month 30

United statesBio cardiorenalJonathan foxIsabelle lousadaBridgebio pharma incCompany new drug applicationEuropean society of cardiology congressCompany phaseEuropean medicines agencyAmerican heart association scientific sessionsDrug administrationAmyloidosis research consortiumBridgebio pharmaNew drug applicationChief medical officerEuropean marketing authorization application

Vera Therapeutics, Inc Announces Executive Changes

Vera Therapeutics, Inc. announced the appointments of two industry veterans to help lead the development of the company?s drug programs including its late-stage product candidate, atacicept, to treat.

United statesStanford universityWilliamd turnerRobertm brennerOrionis biosciencesCelia linAlbert einstein college of medicineVera therapeutics incRegulatory affairsCalifornia state university at long beachSierra oncology incJohns hopkins universityStanford university medical centerGlobal quality at dynavax technologies corporationVera therapeuticsChief medical officer

Vera Therapeutics Announces Appointment of Industry

BRISBANE, Calif., Jan. 08, 2024 (GLOBE NEWSWIRE) Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company developing and.

Stanford universityUnited statesJoyce allaireOrionis biosciencesCelia linMarshall fordyceWilliamd turnerMari purpuraRobertm brennerJohns hopkins universityGlobal quality at dynavax technologies corporationVera therapeutics incCalifornia state university at long beachAlbert einstein college of medicineRegulatory affairsSierra oncology inc

Gene Therapy Briefs: Activist Investor Reported to Take $1B Stake in BioMarin

Gene Therapy Briefs: Activist Investor Reported to Take $1B Stake in BioMarin
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