Belite Stargardt drug shows promising results in a late-stage trial, positioning it for potential regulatory approval.
Browsing: Regulatory & Approvals
Regulatory updates, drug approvals, submissions, and compliance developments from authorities like FDA, EMA, and others.
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.
Kelun Merck ADC shows promise in lung cancer treatment, succeeding in a late-stage trial with potential for first-line approval.
Takeda rare disease drug is under FDA review following a patient death and reports of neutralizing antibodies.
Otsuka FDA approval marks a first for anti-APRIL therapy targeting IgA nephropathy, impacting over 100,000 US patients.
Kelun Merck ADC shows promise in lung cancer treatment, succeeding in a late-stage trial with potential for first-line approval.