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Drug Approval

FDA Alzheimer's Disease FDA Approval FDA Regulations Lecanemab Alzheimer's Treatment Regulatory Agencies Mifepristone Clinical Trials Eli Lilly

FDA Approves Lynkuet, a Nonhormonal Pill for Menopausal Hot Flashes

The once-daily therapy joins an emerging nonhormonal class with FDA-recommended liver tests at baseline and three months.

FDA Approves Lynkuet, a Nonhormonal Pill for Menopausal Hot Flashes

FDA Expands Revumenib Approval to NPM1-Mutant Relapsed/Refractory AML in Patients 1 and Older

FDA Reapproves GSK’s Blenrep for Multiple Myeloma in Narrow Combination Use

FDA Drug Approvals Slowed in Q3 as Missed Deadlines and CRLs Rose

FDA Approves Gazyva for Adults With Active Lupus Nephritis

FDA Clears Tezspire for Nasal Polyps in Patients 12 and Older

FDA Names First 9 Drugs for ‘National Priority’ Fast-Track Reviews, Targeting 1–2-Month Decisions

EMA Panel Recommends Rejecting Rezurock for Chronic Graft-Versus-Host Disease in EU

Cytokinetics Investors Urged to Act as Lead‑Plaintiff Deadline Nears in REMS‑Related Securities Suit

CHMP Backs Brinsupri as First EU Therapy for Non‑Cystic Fibrosis Bronchiectasis

17 GOP Senators Press FDA Over Generic Mifepristone Approval

FDA Clears Monthly Uzedy Injection for Maintenance Treatment of Bipolar I Disorder

Cidara Gains on JP Morgan Coverage Initiation as ESWI Presentation Nears

51 GOP Senators Press FDA and HHS to Curb Abortion Pill Access After New Generic Approval

Sam’s Club Joins Costco in Offering $499 Wegovy and Ozempic

FDA Approves Libtayo as First Immunotherapy for Adjuvant Treatment of High‑Risk CSCC

AstraZeneca’s Baxdrostat Hits Phase 3 Goal With 24‑Hour Blood‑Pressure Cuts

FDA Confirms Safety Review of Mifepristone With No Regulatory Changes Yet

FDA Approves Zoryve 0.05% Cream for Children Ages 2–5 With Mild to Moderate Atopic Dermatitis