Targeted Oncology

FDA Approves Nivolumab Plus AVD for Classical Hodgkin Lymphoma

FDA approval extends nivolumab into first-line stage III/IV cHL in adults and pediatrics, following priority review of the supplemental application for nivolumab plus AVD. SWOG S1826 showed superior ...
The American Journal of Managed Care

FDA Expands Secukinumab Approval to Patients 12 Years and Older With Hidradenitis Suppurativa

The FDA has approved secukinumab (Cosentyx; Novartis) for the treatment of pediatric patients 12 years and older with moderate to severe hidradenitis suppurativa (HS), the company announced. 1 The ...
JD Supra

FDA Extends Scrutiny Over Color Additives Beyond Food to Drug Products

FDA’s recent focus on potentially harmful color additives in food products has expanded to the pharmaceutical sector. In May 2025, FDA issued a draft guidance titled Replacing Color Additives in ...
JD Supra

New FDA Drug Reforms: Congress Extends Voucher Incentive, Clarifies Orphan Exclusivity and Provides Greater Transparency for Q1/Q2 Generic Approvals

In legislation enacted on Feb. 3, 2026, Congress reauthorized the rare pediatric disease priority review voucher program, clarified the scope of orphan drug exclusivity (ODE) and mandated increased ...
Monthly Prescribing Reference

FDA Extends Review of Sparsentan for Focal Segmental Glomerulosclerosis

The new Prescription Drug User Fee Act target date is now April 13, 2026. The Food and Drug Administration (FDA) has extended the review period for sparsentan in focal segmental glomerulosclerosis ...
Monthly Prescribing Reference

FDA Extends Review Period of Hunter Syndrome Gene Therapy

A new Prescription Drug User Fee Act target date of February 8, 2026 has been set for the application. The Food and Drug Administration (FDA) has extended the review for the Biologics License ...
Hosted on MSN

Travere Therapeutics stock slumps after FDA extends drug review timeline to April: Retail is divided on eventual approval

・The timeline extension comes on the heels of the FDA requesting additional information to assess Filspari’s clinical benefit. ・The company submitted responses and the agency determined that the ...
Hosted on MSN

AxoGen: FDA extends PDUFA date for BLA for Avance Nerve Graft to December 5

Axogen (AXGN) announced that the U.S. FDA has extended the Prescription Drug User Fee Act goal date for its Biologics License Application for Avance Nerve Graft by three months to December 5, 2025. On ...
Nasdaq

FDA Extends PDUFA Date of Biohaven's Troriluzole NDA for Rare Disease Spinocerebellar Ataxia

- Spinocerebellar Ataxia (SCA) is a rare, genetic, life-threatening neurodegenerative disease with no available treatment. - Troriluzole has been granted Fast-Track, Orphan Drug Designation (ODD) and ...
PharmTech

From Guidance to Operating Model: Preparing CMC and Quality Systems for FDA's Digital-by-Default Oversight

Taken together, these signals operationalize a data-centric oversight model. They also raise a practical question for CMC and quality leaders: if evidence is increasingly remote-ready and ...
Medscape

FDA Extends Topical Roflumilast’s Atopic Dermatitis Approval to Young Children

The FDA has approved the supplemental new drug application for topical roflumilast cream 0.05% for treating mild-to-moderate atopic dermatitis in children aged 2-5 years, the manufacturer announced in ...