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Regulatory Affairs

FDA Approval FDA Regulations FDA Approval Process Licensing Agreements NDA Process European Commission Approval Eli Lilly and Company Drug Approval Novo Nordisk Market Authorization Market Approval Approval Processes

6 ARTICLES

last mo.

FDA Grants Accelerated Approval to Genglycos for Glycogen Storage Disease Type Ia

The decision allows a one‑time AAV8 gene therapy for patients eight and older subject to two years of confirmatory data plus up to ten years of long‑term monitoring.

3 ARTICLES

3mo ago

FDA Delays Rivoceranib Approval Citing Manufacturing Compliance at Chinese Plant

5 ARTICLES

4mo ago

Regulatory Affairs

FDA Grants Accelerated Approval to Genglycos for Glycogen Storage Disease Type Ia

FDA Delays Rivoceranib Approval Citing Manufacturing Compliance at Chinese Plant

Fulcrum Halts Pociredir Development After FDA Flags PRC2 Cancer Risk

Novo Nordisk’s Oral Semaglutide Lowers HbA1c in Teens in Pivotal Trial

For Third Time, FDA Rejects Aldeyra’s Dry-Eye Drug Reproxalap Over Efficacy

FDA Rejects Disc Medicine’s Bitopertin for EPP After Questioning Surrogate Endpoint