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
Regulatory Pfizer’s Hympavzi secures FDA expanded indications for haemophilia pharminent June 9, 2026
Regulatory Biogen’s salanersen gains FDA breakthrough therapy designation for SMA pharminent June 5, 2026
Regulatory FDA taps prior knowledge to expedite cell and gene therapy development pharminent June 3, 2026
Regulatory FDA Issues Draft Guidance to Help Accelerate Cell and Gene Therapies for Patients pharminent June 2, 2026
Regulatory FDA approves AstraZeneca’s Imfinzi-BCG combination for NMIBC therapy pharminent June 1, 2026
Regulatory Replimune gives cancer immunotherapy a third try after FDA leadership shakeup pharminent May 29, 2026
