Regulatory Updates

Alnylam pipeline update: AMVUTTRA catalysts, outlook and profitability

U.S. FDA · ATTR-CM · 5 min

FDA Approves Lumasiran for PH1: What BD and Investors Should Know

FDA · Acute Hepatic Porphyria · 8 min

Manufacturing pipeline approvals: what the evidence confirms

4 min

AbbVie Cerevel acquisition closes in $8.7B neuroscience deal

immunology · 6 min

Lenacapavir posts 100% HIV prevention in PURPOSE 1: what it means

HIV · 9 min

Vabysmo gains EU approval for retinal vein occlusion: what changes next

FDA · retinal vein occlusion · 6 min

GSK’s Blenrep returns to the US market after FDA approves resubmission

FDA · blood cancer · 5 min

Moderna mRNA-1083 Phase 3 data show stronger flu and COVID immune response

FDA · COVID-19 · 6 min

Novartis remibrutinib wins Phase 3 in CSU: what it means

chronic spontaneous urticaria · 9 min

EMA backs datopotamab deruxtecan, but lung cancer access remains unclear

EMA · lung cancer · 9 min

FDA approves Vertex’s Journavx as first non-opioid pain drug for acute pain

FDA · moderate-to-severe acute pain · 7 min

Biogen and Eisai expand Leqembi access with subcutaneous maintenance dosing

Alzheimer's disease · 5 min