Regulatory Affairs

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

Management warns currency headwinds could persist into 2026.

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