Regenxbio FDA rejection impacts its gene therapy for Hunter Syndrome, marking a significant regulatory setback.
Browsing: Regulatory & Approvals
Regulatory updates, drug approvals, submissions, and compliance developments from authorities like FDA, EMA, and others.
Amgen inflammatory drug faces regulatory scrutiny as the company refuses FDA’s withdrawal request, impacting its market strategy.
Tenpoint FDA approval marks a significant step for its presbyopia eye drop, supported by $235 million in funding.
Regenxbio gene therapy trials for Hunter and Hurler syndromes are suspended by the FDA due to safety concerns involving a brain tumor.
Intellia CRISPR trial resumes after FDA hold lifted. New safeguards are in place following a participant’s death.
FDA multiple myeloma drugs pathway accelerates approvals, allowing therapies to clear based on tumor cell elimination.
Valneva Chikungunya vaccine is withdrawn from the US market following FDA suspension, raising concerns about its future.
Lilly obesity pill orforglipron is under FDA review with a decision expected in Q2 2025, aiming to compete with Novo Nordisk’s offerings.
GSK Ionis hepatitis B drug advances to global regulatory filings, aiming for functional cures in chronic infections.
FDA approval decisions in early 2026 include multiple national priority vouchers and a gene therapy, impacting the pharmaceutical landscape.