Centerpiece of $14B Karuna deal, launched last year, falls short of significant effect in combination with atypical antipsychotics

Lilly to seek re-examination. Also in March meeting, CHMP backs label expansions for Opdivo, Tevimbra and more

How the once-dominant cancer company has overhauled its strategy for long-term growth

Agency approves at least nine new therapies; adds new indications or patient populations to a dozen marketed drugs

But partnership lands fourth on overall upfront payment

Ionis’ first wholly owned product among three rare disease therapies up for approval. BMS expecting decision on subcutaneous Opdivo

Eleven label expansions also among committee’s November recommendations

Plus: Agency approves Pfizer’s hemophilia A and B mAb, and label expansions for five products

In BioCentury’s latest Clinical Report, Skysona’s cancer risk comes into focus, GSK’s IL-5 meets in rhinosinusitis, Jasper’s c-Kit improves hives, and more

Decisions include Opdivo as perioperative therapy for NSCLC, and a Lumakras combination for mCRC