Regulatory Affairs

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Fulcrum Halts Pociredir Program After FDA Says PRC2 Inhibitors Carry Cancer Risk

FDA meeting minutes concluding a class-level malignancy signal removed a viable path for the EED-targeting sickle cell therapy.

MediWound Posts Weak Q1 but Reaffirms 2026 Revenue Target as BARDA Deal and Factory Upgrades Drive H2 Plan

Cormedix Lifts 2026 Outlook After Q1 Beat, Sets H2 FDA Filing Plan for Rizzeo

FDA Says Estrogen Patches Not in Official Shortage as Pharmacies Report Scarcity

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

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

ARCHIMED to Acquire Esperion for $3.16 a Share Plus CVR

iRhythm Lifts 2026 Outlook After Strong Q1 Growth and Margin Gains

Hyderabad Paediatrician Quits IAP After Legal Notices Over ORS Marketing Row

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