Even given huge optimism to date for immunotherapy checkpoint inhibitors, the rapid approval of Bristol’s PD-1 inhibitor nivolumab in squamous type lung cancer is a welcome surprise and bodes well for the class in the future.
FDA’s swift approval of the anti-PD-1 Opdivo (nivolumab) for a new use in second-line lung cancer means a competitive market advantage for Bristol-Myers Squibb Co., at least in the short term, for the most valuable indication targeted by cancer immunotherapy.
Opdivo is a member of the programmed-death family of immune checkpoint inhibitors, which release the brakes on mechanisms that would...
The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.
A 26 June deadline looms for the final guidance even though a draft guidance was removed from the agency’s website to comply with President Trump’s gender ideology executive order. The concepts underpinning the guidance are still relevant, legal experts say.
Expanded funding for cost recovery could dovetail with FDA Commissioner Martin Makary’s idea for a “conditional approval” pathway based on a plausible mechanism of action.
Julian Beach, interim executive director of healthcare quality and access at the UK drug regulator, the MHRA, tells the Pink Sheet how the agency is responding to increased efforts to develop bacteriophage therapies.
The US FDA ended efforts to regulate lab-developed tests as medical devices for now when it did not appeal a decision from the Eastern District of Texas that tossed out the agency's final rule.
The UK regulator wants to help companies to develop bacteriophages for the treatment of infections. Its first guidance on this topic offers advice to researchers and sets out the regulatory requirements they will need to meet.
A UK research team has used artificial intelligence to find new treatments for cancer using existing US Food and Drug Administration-approved medicines that are not normally not used for the disease.
