Briefs from primary sources
The stream: Approvals
Two-sentence briefs on FDA announcements, Federal Register documents and ClinicalTrials.gov records, each linked to its source.
Machine-summarized from primary sources; not independently reported. How we use automation
Friday, October 16, 2026
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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
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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
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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
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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
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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
Thursday, October 15, 2026
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EMA recommends authorisation of Rasonque for metastatic pancreatic cancer
EMA's CHMP has recommended granting a marketing authorisation for Rasonque (daraxonrasib) for adults with metastatic pancreatic adenocarcinoma who have received at least one prior treatment. The recommendation follows a phased review that shortened assessment to less than 150 days, with Rasonque showing a median overall survival of 12.4 months versus 6.7 months for chemotherapy in a phase 3 study of 500 patients.
Source: EMA news release, October 15, 2026
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CHMP adopts positive opinion on Rasonque for metastatic pancreatic cancer
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on 15 October 2026, recommending marketing authorisation for Rasonque, a daraxonrasib monotherapy for adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy. The product will be available as 100 mg and 150 mg film-coated tablets and is designated as an orphan medicine.
Source: EMA medicine page (CHMP opinion), October 15, 2026
Wednesday, October 14, 2026
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FDA approves expanded indication for nogapendekin alfa inbakicept-pmln for BCG-unresponsive NMIBC
On October 14, 2026, the FDA approved nogapendekin alfa inbakicept-pmln (Anktiva) with BCG for adults with BCG-unresponsive non-muscle invasive bladder cancer, adding high-grade papillary-only tumors to the prior indication for carcinoma in situ. The approval is based on efficacy data from Cohort A of QUILT-3.032, which showed a 62% complete response rate (95% CI: 51, 73).
Source: FDA approval notification, October 14, 2026
Friday, October 9, 2026
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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