Baloxavir marboxil appraisal terminated for children

NICE has terminated the appraisal of baloxavir marboxil for treating and preventing influenza in children aged 1 to 11 years. The decision was made because the company failed to provide an evidence submission for the technology appraisal.

NICE Guidance: Durvalumab for Muscle-Invasive Bladder Cancer

NICE has published technology appraisal guidance (TA1138) recommending durvalumab with gemcitabine and cisplatin for the neoadjuvant and adjuvant treatment of muscle-invasive bladder cancer. The guidance includes information on commercial arrangements and reporting adverse events.

NICE Guidance: Epcoritamab for Follicular Lymphoma

NICE has published technology appraisal guidance (TA1139) recommending epcoritamab (Tepkinly) for treating relapsed or refractory follicular lymphoma in adults after two or more lines of systemic treatment. The guidance outlines evidence-based recommendations for healthcare professionals.

Medicare and Medicaid CY 2026 Payment Policies Correction

The Centers for Medicare & Medicaid Services (CMS) issued a correction to the Calendar Year 2026 payment policies under the Physician Fee Schedule and other changes to Part B payment and coverage policies. This correction addresses specific aspects of the previously published rule concerning Medicare and Medicaid programs.

Adapalene Monograph Revision Proposed for Solubility Issue

The USP Small Molecules 3 Expert Committee intends to revise the Adapalene monograph to address a potential solubility issue in the Organic Impurities test. The proposed changes include allowing a larger volume of tetrahydrofuran for the standard stock solution, introducing a two-table format for retention times, and deleting the Limit of Triethylamine test.

Dapagliflozin Tablets Monograph Revision Notice

The USP is issuing a notice of intent to revise the Dapagliflozin Tablets monograph, with a targeted official date of June 1, 2026. This revision is being made in response to comments received, aiming to incorporate feedback into the monograph.

USP Notice: Revision to Sennosides Tablets Monograph Testing Method

The USP has issued a Notice of Intent to Revise the Sennosides Tablets monograph testing method. This revision aims to align the testing procedure with recent changes made to the general sennosides monograph, using sennosides A and B as marker compounds. The targeted official date for this revision is August 1, 2027.

Carbachol Monograph Revision - Assay Criteria

The United States Pharmacopeia (USP) is revising the Carbachol monograph to widen the acceptance criteria for Assay from NMT 99.0%-101.0% to NMT 98.0%-102.0%. This change aims to accommodate FDA-approved products with wider specifications and is targeted for publication on May 29, 2026, with an official date of June 1, 2026.

USP Notice: Revision to Guaifenesin, Pseudoephedrine HCL, Dextromethorphan Capsules Monograph

The United States Pharmacopeia (USP) has issued a notice of intent to revise the monograph for Guaifenesin, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Capsules. The revision aims to update a cross-reference to an omitted monograph and incorporate the full text of a previously official assay procedure.

HHS Proposed Rule for Health Insurance Exchanges 2027 Payment Parameters

HHS, through CMS, has issued a proposed rule outlining benefit and payment parameters for Health Insurance Exchanges for the 2027 plan year. The proposal includes changes to risk adjustment programs, user fees, marketing practices, and plan options, with a public comment deadline of March 13, 2026.