Regulatory GSK’s $10.6B Nuvalent bet pays off early as FDA approves lung cancer drug pharminent July 23, 2026
Regulatory Merck dives into cholesterol with first FDA approval for oral PCSK9 inhibitor pharminent July 16, 2026
Regulatory Celcuity gains FDA approval for closely watched breast cancer drug pharminent July 15, 2026
Regulatory FDA freezes CRL trove as ‘radical transparency’ push hits speedbump pharminent July 9, 2026
Regulatory Novartis receives European Commission approval for Itvisma for spinal muscular atrophy pharminent July 2, 2026
Regulatory Eli Lilly and Regeneron among 7 companies picked for FDA PreCheck pilot program pharminent July 1, 2026
Regulatory Sarepta secures early 2027 FDA decision for Duchenne drugs, pushing past confirmatory fail pharminent July 1, 2026
Regulatory Lilly’s Jaypirca receives CHMP positive opinion for CLL in Europe pharminent June 29, 2026
Regulatory Replimune gets early August decision date for twice-rejected melanoma drug pharminent June 26, 2026
Regulatory Ionis secures market expansion for Tryngolza as FDA clears severe hypertriglyceridemia use pharminent June 25, 2026
Regulatory FDA’s uniQure, REGENXBIO reversals could bolster other near-term rare disease applications pharminent June 25, 2026
Regulatory Disc’s FDA meeting sets ‘clear path’ for embattled rare blood disease drug pharminent June 10, 2026
Regulatory ADA: Lilly bests Novo again, takes GLP-1 pill Foundayo to FDA for diabetes approval pharminent June 9, 2026
