Merck unveiled event-free survival results for Keytruda in triple-negative breast cancer following failure earlier this year to gain approval on a surrogate endpoint.
Merck & Co., Inc. has bolstered its chances of winning US Food and Drug Administration approval for Keytruda (pembrolizumab) in neoadjuvant triple-negative breast cancer (TNBC) with Phase III trial data showing a benefit in event-free survival. But the data do not support the use of a surrogate endpoint the company unsuccessfully tried to use before.
In May, Merck had announced that the KEYNOTE-522 study testing Keytruda and chemotherapy before surgical resection followed by the PD-1...
The House Appropriations Committee wants an analysis of how issues that led to CRLs could have been resolved within the first review cycle and seeks an agency crackdown on counterfeit GLP-1 agonists.
With a 25-27 June meeting looming, HHS Secretary Robert F. Kennedy Jr. can fill all 17 spots on the CDC's Advisory Committee on Immunization Practices with people he says will "exercise independent judgment."
The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.
Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.
The UK drug regulator, the MHRA, is set to launch its decentralized manufacturing framework in July, and has issued a series of guidance documents that it believes will help companies and also be of value to other countries that are considering how best to regulate the fledging sector.
Companies operating in Argentina may get their medicines to the market more quickly thanks to new updates to the medicines authorization system.
The UK government has acknowledged that sponsors of clinical trials for rare diseases face challenges around patient recruitment and trial design, which will be addressed in its clinical trials reform, a lawyer says.
