Regulatory Affairs

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

The sale signals growing demand for real-time bedside navigation that standardizes feeding tube placement.

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

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

Ironwood Sets 2026 Targets After LINZESS Price Cut as Shares Surge

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

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

Merck Wins FDA Approval for Subcutaneous Keytruda as EU Panel Backs Infant RSV Preventive

FDA Weighs Ending Pfizer COVID-19 Authorization for Children Under 5