AbbVie Took Two EU Approvals in One Day, Both for Diseases Payers Have Called Cosmetic
The European Commission approved RINVOQ for non-segmental vitiligo and, the same day, for severe alopecia areata, both in adults and adolescents aged 12 and over.
The European Commission approved RINVOQ for non-segmental vitiligo and, the same day, for severe alopecia areata, both in adults and adolescents aged 12 and over.
ANVISA approved five semaglutide products in a single day, including the one Sandoz will sell. Ozempic’s Brazilian patent expired in March.
A second positive Phase 3 in a second tumour makes Ris-Rez the only B7-H3 antibody-drug conjugate with late-stage wins across more than one cancer.
Thailand approved a first-in-class oral antibiotic for gonorrhoea six months after the US, a benchmark for how fast new medicines can reach lower-income markets.
Enhertu with pertuzumab and Trodelvy with Keytruda both won CHMP opinions for first-line metastatic breast cancer, moving ADCs from last resort to standard.
Europe recommended approval for a CETP inhibitor, a class with four prior failures, on LDL-lowering trials. The outcomes trial that decides it has not read out.
LYTENAVA becomes the first FDA-approved ophthalmic bevacizumab for wet AMD, with 12 years of exclusivity, on a molecule already used in most first-line treatment.
Agilent won its eighth CE-marked companion diagnostic indication for a single PD-L1 assay, each one riding on a label expansion Merck paid to generate.
Dassault Systèmes will pay $1.8 billion cash for ArisGlobal, whose platform processes more than 12 million patient safety reports annually for 200 customers.
A drug worth $1.9bn of 2030 revenue cost AstraZeneca £19bn in a day, leaving roughly $800m of headroom above its $80bn goal with the risky readouts still ahead.