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Regulatory

FDA, EMA and policy developments that move the longevity market.

151 regulatory items tracked

Item	Category	Significance	Date
Enveda reports positive Phase 1 results for ENV-308, first pill designed from the chemistry of exercise	Other	High	08/18/26
FDA grants accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg) plus nivolumab for advanced melanoma	FDA Approval	Medium	08/06/26
FDA approves mFLUSIVA (mRNA-1010), Moderna’s mRNA influenza vaccine for adults 50 and older	FDA Approval	High	08/06/26
FDA Approves Lipfendra (enlicitide) as First Oral PCSK9 Therapy for LDL Cholesterol Reduction	FDA Approval	Medium	07/16/26
FDA Grants RMAT Designation to Allocetra for Age-related Knee Osteoarthritis	RMAT Designation	High	07/13/26
Enlivex receives FDA RMAT designation for Allocetra in age-related knee osteoarthritis	Designation	High	07/13/26
FDA approves at-home subcutaneous LEQEMBI starting dose for early Alzheimer's disease	Approval	Low	07/13/26
FDA Approves At-home Subcutaneous Starting Dose of Leqembi for Early Alzheimer's Disease	FDA Approval	High	07/12/26
FDA Grants Accelerated Approval to Trutakna (atacicept-vymj) for Proteinuria Reduction in Primary IgA Nephropathy	FDA Accelerated Approval	High	07/06/26
FDA Approves First Gene Therapy for Young Children with Sickle Cell Disease	FDA	Medium	07/01/26

Showing 10 of 151 regulatory items

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