FDA chiefs critique plans to toughen vaccine standards, impacting COVID-19 protocols.
Browsing: Regulatory & Approvals
Regulatory updates, drug approvals, submissions, and compliance developments from authorities like FDA, EMA, and others.
UniQure Huntington’s gene therapy faces challenges as FDA deems current data insufficient for approval, affecting market outlook.
Capricor Duchenne cell therapy shows positive results, potentially reversing FDA rejection and quadrupling shares.
FDA animal testing guidance reduces non-human primate use, aiding U.S. drugmakers amid global competition.
Belite Stargardt drug shows promising results in a late-stage trial, positioning it for potential regulatory approval.
Otsuka secures FDA approval for its first anti-APRIL therapy targeting IgA nephropathy, marking a significant advancement in rare kidney disease treatment.
Otsuka FDA Approval marks a significant milestone with the first anti-APRIL therapy for IgA nephropathy, impacting the rare kidney disease market.
Kelun Merck ADC shows promise in lung cancer treatment, succeeding in a late-stage trial with potential first-line approval.
Takeda rare disease drug is under FDA investigation following a patient death and reports of neutralizing antibodies.
Otsuka FDA approval marks a first for anti-APRIL therapy targeting IgA nephropathy, potentially impacting the rare kidney disease market.