FDA's approval of Merck's Keytruda/chemo combo based on Phase II data secures the company's position in the prized first-line lung cancer indication, but Phase III readouts from other combination trials are right around the corner.
FDA's accelerated approval of Merck & Co. Inc.'s Keytruda/chemotherapy combination for first-line non-small cell lung cancer gives the company yet another victory in the immuno-oncology space, though readouts for other combinations could alter the market dynamics dramatically within the next year.
The US FDA granted accelerated approval on May 10 for Merck's PD-1 inhibitor Keytruda (pembrolizumab) in combination with Eli...
The first twice-yearly option for HIV prevention has been approved by the US Food and Drug Administration in an advance that “brings us closer than ever to ending the HIV epidemic,” said CEO Daniel O’Day.
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
UroGen’s Zusduri was approved despite an advisory committee vote recommending against it in May. It is the first approved drug for a type of recurring bladder cancer.
The US FDA approved taletrectinib for the treatment of ROS1+ NSCLC, where Nuvation hopes it will lead the category with a best-in-class position.
Oral RNA splicing modulator has gone into a Phase II/III trial
Highlights from Day 3 of the BIO International Convention include the realities of MFN pricing, AstraZeneca's R&D plans for obesity, the need for resources for FDA's rare disease hub and reactions to the Commissioner's National Priority Review Voucher program.
Government policy ramifications and tight financial markets mean it’s time to prepare strategically for a better business development environment, EY suggests.
