The Priority Review

The stream · Daily digest

The stream: Friday, October 9, 2026

13 briefs from ClinicalTrials.gov, the Federal Register and FDA, grouped by desk. Each is two sentences from one primary source, linked to it.

Machine-summarized from primary sources; not independently reported. How we use automation

Clinical trials · 6

  1. Viking Therapeutics registers Phase 3 trial of VK2735 for weight management

    The study, titled SUNRISE 1, is a Phase 3 randomized, double-blind, placebo-controlled trial of VK2735 administered orally for weight management. It plans to enroll 560 participants starting October 15, 2026, with primary completion projected for July 2028.

    Source: ClinicalTrials.gov registry record, October 9, 2026

  2. FrieslandCampina registers Phase 3 trial of infant formula with bio-active ingredients

    The study was first posted on ClinicalTrials.gov on October 9, 2026, and plans to enroll 387 participants with a start date of January 2027. It aims to compare growth, immune parameters, and gut health between infants receiving the investigational formula and those receiving a control formula.

    Source: ClinicalTrials.gov registry record, October 9, 2026

  3. Viking Therapeutics registers Phase 3 trial of VK2735 for weight management in type 2 diabetes

    The study plans to enroll 560 participants and is expected to begin on October 16, 2026. It plans to evaluate oral VK2735 for weight management in adults with type 2 diabetes who are obese or overweight.

    Source: ClinicalTrials.gov registry record, October 9, 2026

  4. Hoffmann-La Roche posts results of Phase 3 IMpower030 atezolizumab trial in resectable NSCLC

    Results for the IMpower030 study were first posted on ClinicalTrials.gov on October 9, 2026. The Phase 3 trial enrolled 453 participants and completed primary data collection on October 1, 2025.

    Source: ClinicalTrials.gov results record, October 9, 2026

  5. Hoffmann-La Roche posts results of Phase 3 alectinib rollover study

    Results for the study were first posted on ClinicalTrials.gov on October 9, 2026. The completed Phase 3 rollover study enrolled 50 participants and compared alectinib with crizotinib in patients with ALK- or RET-positive cancer.

    Source: ClinicalTrials.gov results record, October 9, 2026

  6. Sanofi posts results of Phase 3 Itepekimab trial in COPD

    The study, NCT04751487 (AERIFY-2), enrolled 1234 participants and completed in April 2025. It evaluated itepekimab versus placebo on exacerbation rates, pulmonary function, and safety in moderate-to-severe COPD patients.

    Source: ClinicalTrials.gov results record, October 9, 2026

Regulation · 6

  1. FDA corrects withdrawal notice of 16 ANDAs

    The FDA issued a correction to a June 3, 2026 notice that announced the withdrawal of approval of 16 abbreviated new drug applications, effective July 6, 2026. The correction removes entries for ANDA 207366, ANDA 212957, and ANDA 218638, noting that Navinta LLC requested the approvals not be withdrawn, so those approvals remain in effect.

    Source: Federal Register notice, October 9, 2026

  2. FDA withdraws approval of Amneal's celecoxib ANDA

    FDA withdraws approval of abbreviated new drug application 208833 for celecoxib capsules 50 mg, 100 mg, 200 mg, and 400 mg held by Amneal Pharmaceuticals of New York, LLC. Amneal requested the withdrawal and waived its opportunity for a hearing.

    Source: Federal Register notice, October 9, 2026

  3. FDA withdraws approval of 37 ANDAs

    The agency is withdrawing approval of 37 abbreviated new drug applications from multiple applicants. The applicants notified the FDA that the drug products were no longer marketed and requested the approvals be withdrawn.

    Source: Federal Register notice, October 9, 2026

  4. FDA issues priority review voucher for ZANVASTRO

    FDA approved ZANVASTRO on September 3, 2026. FDA issued a priority review voucher to the sponsor, Ionis Pharmaceuticals, Inc., after determining the product meets the criteria under the FD&C Act.

    Source: Federal Register notice, October 9, 2026

  5. FDA classifies hematopoietic cell enrichment kit as class II device

    The order designates the kit as a class II device with special controls. The special controls will be part of the codified language for classification of the hematopoietic cell enrichment kit.

    Source: Federal Register rule, October 9, 2026

  6. FDA classifies infant pulse rate and oxygen saturation monitor as class II

    The order assigns the device to class II, adding special controls to the codified language. The action is expected to enhance patients' access to beneficial innovative devices by reducing regulatory burdens.

    Source: Federal Register rule, October 9, 2026

Approvals · 1

  1. FDA approves Hovilpri for immunocompromised patients with HSV lesions

    The FDA approved Hovilpri (pritelivir) tablets for adults with weakened immune systems who have mucocutaneous lesions caused by herpes simplex virus and have not responded to acyclovir, valacyclovir, or famciclovir. In a Phase 3 trial, 63% of patients treated with Hovilpri had all lesions healed by 28 days versus 34% with other medications.

    Source: FDA approval notification, October 9, 2026