Trodelvy Now Covers First-Line TNBC Across PD-L1 Status. The Two Regimens Are Not Equally Tolerated.
Serious adverse reactions ran at 38% in the combination trial against 26% in the monotherapy trial. Same drug, same line, different companion.
Clinical Read
Two First-Ever Rare Disease Approvals Landed the Same Day. Both Were Measured by Proxy.
Pasatru’s flare benefit is clinician-assessed only. GENGLYCOS is indicated to reduce cornstarch intake. Two firsts, both measured a step from the patient.
The First Phase 3 Win for an mRNA Cancer Therapy Arrives Without Its Numbers
The first Phase 3 win for an mRNA cancer therapy. Statistical significance was reported, effect size was not, and overall survival is still open.
MoonLake Says IZAR-1 Met Every Endpoint and Will Not Show You the Placebo Arm
MoonLake disclosed 42.1% ACR50 and withheld the placebo arm. An absolute response rate without a comparator is a number, not a result.
Replimune Won Accelerated Approval on 91 Evaluable Patients and a 24% Response Rate
CBER took a 24% response in 91 evaluable patients, one day after the same committee voted nine to three against Capricor. Measurement, not size.
An FDA Panel Voted 9-3 Against Capricor on Cardiomyopathy and Never Voted on the Endpoint That Passed
The ballot was the outcome. A drug’s strongest dataset sitting off the voting question is not a footnote, it is the whole result.
A B7-H3 Antibody Drug Conjugate Just Won a Second Phase 3, in a Second Tumour
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.
ADCs Graduated From Salvage to First Line, Twice in a Week
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 Backs the Cholesterol Class That Failed Four Times
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.