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Regulatory Affairs

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Pfizer’s Oral Drug Shows Strong Phase 3 Results in Nonsegmental Vitiligo

The company says the medicine delivered meaningful facial and total-body repigmentation and will pursue regulatory approval for adult patients.

FDA Approves Lytenava, First Ophthalmic Bevacizumab for Wet AMD

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