Regulatory Affairs

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Evolus Posts Q1 Growth and Second Straight Positive Adjusted EBITDA, Reaffirms 2026 Outlook

Steady demand for injectables supports guidance despite a potential U.S. tariff on South Korean drugs.

iRhythm Lifts 2026 Outlook After Strong Q1 Growth and Margin Gains

ARCHIMED to Acquire Esperion for $3.16 a Share Plus CVR

Cerus Raises 2026 Outlook After 24% Q1 Product Revenue Jump as INT200 Filing Nears

Delhi Court Pauses DRL’s ‘Olymviq’ Rollout in Ozempic Trademark Fight

ENvue Medical Lands Detroit Teaching Hospital, Lifting U.S. Footprint to 39 Sites

Co-Diagnostics Expands CoSara Territory to Four South Asian Countries

Eli Lilly to Invest $3 Billion in China to Build Orforglipron Manufacturing

Ironwood Sees LINZESS Above $1.1 Billion in 2026 as FDA-Aligned STARS II Nears Launch

Dexcom Posts Q4 Beat, Launches 15‑Day G7, Reaffirms 2026 Outlook

EMA Panel Recommends EU Withdrawal of Levamisole Over Rare Brain Risk

Roche Posts 2025 CER Growth but Misses Profit Forecast as Strong Franc Weighs

Samsung Epis Targets 20 Biosimilars by 2030, Adds Six Candidates and Readies First ADC Trial

Eli Lilly Prepares €15 Billion Abivax Offer, Eyes Next Wave of Weight-Loss Drugs

Novo Nordisk Leans on Wegovy’s New MASH Indication and First Oral Obesity Pill to Rebound in 2026

Ironwood Sets 2026 Targets After LINZESS Price Cut as Shares Surge

Cosmo’s Clascoterone Meets Phase III Goals in Male-Pattern Baldness Trials

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

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

ABIVAX to Present Late-Breaking Phase 3 Ulcerative Colitis Data on Oct. 6 at UEG Congress