The Priority Review

The stream · Daily digest

The stream: Friday, October 16, 2026

12 briefs from ClinicalTrials.gov, FDA and the Federal Register, 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

Approvals · 5

  1. FDA approves Brytly, a nonprescription eye drop for eye redness

    The FDA approved Brytly, apraclonidine ophthalmic solution 0.125%, for relief of eye redness due to minor irritations. The approval is the first nonprescription eye drop containing apraclonidine and is available to adults and children 12 years of age and older.

    Source: FDA approval notification, October 16, 2026

  2. CHMP recommends marketing authorisation for Kizfizo

    The Committee for Medicinal Products for Human Use adopted a positive opinion on 15 October 2026, recommending a marketing authorisation for Kizfizo, a 40 mg/ml oral suspension of temozolomide, for newly diagnosed glioblastoma multiforme in adults and for recurrent or progressing malignant glioma in adults and children from the age of one year. The applicant is Orphelia Pharma and the product is designated an orphan medicine.

    Source: EMA medicine page (CHMP opinion), October 16, 2026

  3. CHMP adopts positive opinion on Yuviwel for achondroplasia

    The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on 15 October 2026, recommending marketing authorisation for Yuviwel (navepegritide) for children 2 years and older with achondroplasia. The opinion notes that Yuviwel improves annualised growth velocity by 1.49 cm versus placebo in a 52-week trial.

    Source: EMA medicine page (CHMP opinion), October 16, 2026

  4. CHMP recommends marketing authorisation for Neuzafy

    On 15 October 2026 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Neuzafy, a filgrastim biosimilar. The applicant is CuraTeQ Biologics (Malta) Limited and Neuzafy will be available as 30 MU/0.5 ml and 48 MU/0.5 ml solutions for injection/infusion.

    Source: EMA medicine page (CHMP opinion), October 16, 2026

  5. CHMP adopts positive opinion on Fovlussea

    The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on 15 October 2026, recommending a marketing authorisation for Fovlussea, a ranibizumab biosimilar for several retinal conditions. The applicant is Accord Healthcare S.L.U., and the product will be available as a 10 mg/ml solution for injection.

    Source: EMA medicine page (CHMP opinion), October 16, 2026

Clinical trials · 4

  1. AstraZeneca registers Phase 3 trial of durvalumab and FLOT in Chinese gastric cancer patients

    The study, titled MATTERHORN-CN, plans to enroll 140 participants and plans to start on November 30, 2026. It compares neoadjuvant-adjuvant durvalumab plus FLOT chemotherapy to placebo plus FLOT in resectable gastric and gastroesophageal junction cancer.

    Source: ClinicalTrials.gov registry record, October 16, 2026

  2. Eli Lilly posts results of Phase 3 lebrikizumab trial in atopic dermatitis

    Results for the Phase 3 trial of lebrikizumab with or without topical corticosteroid treatment in participants with moderate-to-severe atopic dermatitis were first posted on ClinicalTrials.gov on October 16, 2026. The completed study enrolled 301 participants and began on April 24, 2024.

    Source: ClinicalTrials.gov results record, October 16, 2026

  3. Eli Lilly posts results of Phase 3 orforglipron vs dapagliflozin study

    The company posted results for the ACHIEVE-2 study, a Phase 3, randomized, open-label trial that enrolled 962 participants with type 2 diabetes. The study compared once-daily oral orforglipron (LY3502970) with dapagliflozin and completed primary data collection on September 26, 2025.

    Source: ClinicalTrials.gov results record, October 16, 2026

  4. Nektar posts results of Phase 2/3 NKTR-255 trial in relapsed/refractory large B-cell lymphoma

    Results for the study were first posted on ClinicalTrials.gov on October 16, 2026. The terminated study enrolled 15 participants and had a primary completion date of May 22, 2024.

    Source: ClinicalTrials.gov results record, October 16, 2026

Policy · 2

  1. CMS, SBA, Take Command discuss CHOICE Arrangements for Ohio small businesses

    The Centers for Medicare & Medicaid Services, the Small Business Administration, and Take Command met to explore CHOICE Arrangements, a tax-advantaged contribution model that lets Ohio employers replace traditional group plans with individual coverage options. CMS Administrator Dr. Mehmet Oz said CHOICE Arrangements help Ohio employers better manage healthcare costs while empowering workers to choose coverage that meets their individual needs.

    Source: CMS press release, October 16, 2026

  2. Actinium Pharmaceuticals names Sean Maenpaa senior vice president of business development

    The appointment takes effect on October 12, 2026, and the new executive will lead partnering, licensing and strategic transactions across Actinium's targeted radiotherapy pipeline. He brings more than two decades of oncology business development experience, including senior roles at Bayer, Clovis Oncology, Telix Pharmaceuticals and BWXT Medical.

    Source: Company press release (PR Newswire), October 16, 2026

Regulation · 1

  1. FDA announces support for forward compatibility of eCTD 4.0

    The FDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research announced support for forward compatibility of Electronic Common Technical Document (eCTD) Version 4.0. This notice informs stakeholders that submissions based on eCTD 4.0 are supported for forward compatibility.

    Source: Federal Register notice, October 16, 2026