Good morning, and happy hump day. This week we learned of something new the FDA regulates. (No spoilers! Read on to find out.) Today’s edition: We break down the details of the Biden administration’s $30 billion ask for additional covid-19 funding, and vaccination during pregnancy may provide protection to infants. But first: Major questions on…
After 7 years of explosive growth, the development of PD-1/PD-L1 immune checkpoint inhibitor (ICI) therapy underwent a course correction last year, with the withdrawal of a range of indications due to study results that failed to reach thresholds for confirming clinical benefit. These withdrawals have had a muted impact on clinical practice so far, experts…
TUESDAY, Feb. 15, 2022 (HealthDay News) — In a tight vote, the U.S. Senate on Tuesday confirmed Dr. Robert Califf to once again head the U.S. Food and Drug Administration, ending the agency’s year-long stretch without a permanent leader. Six Republicans crossed over to support Califf in the Senate’s 50-46 vote, while five Democrats opposed…
It’s official – President Joe Biden’s choice for FDA commissioner, Robert Califf, has been confirmed to the role after a narrow 50 to 46 vote in the Senate that relied on crossover Republican votes. That bipartisan support proved to be essential, with six Republican senators casting their lot for Califf to outweigh the five Democrats…
Robert Califf will lead the Food and Drug Administration once again after the Senate voted 50-46 Tuesday to confirm him, overcoming opposition from some lawmakers over his industry ties and the agency’s past actions on an abortion-inducing drug. Califf will be tasked with overseeing the agency as it weighs clearing Pfizer Inc.’s Covid-19 shot for kids…
WASHINGTON — President Biden, who came into office vowing to “reinvigorate our national science and technology strategy,” is now facing a leadership vacuum that may threaten his ambitious research agenda, which stretches well beyond fighting the coronavirus pandemic. Both the Food and Drug Administration and the National Institutes of Health lack permanent leaders. Mr. Biden’s health secretary,…
CMS is coming under increasing pressure to modify its proposed national coverage decision for anti-amyloid mAbs, including Biogen’s Aduhelm. Congressional attention could be reflected in legislation coupled with reauthorization of FDA medical product user fees. In separate letters released Wednesday, Republican members of the House of Representatives and patient advocacy groups suggested that in proposing…
WASHINGTON — Some of the nation’s most influential doctors and public health groups are orchestrating a mad-dash effort to convince senators to confirm Robert Califf, President Biden’s pick to lead the Food and Drug Administration. Advocacy groups like the Campaign for Tobacco-Free Kids and Friends of Cancer Research are calling lawmakers and their staff. The…
President Joe Biden on Wednesday committed the nation to lowering the age-adjusted death rate from cancer by at least 50% over the next 25 years, by reviving the Cancer Moonshot federal effort he launched and led six years ago as vice president. President Biden said Moonshot also aims to improve the experience of people and…
President Biden announced an ambitious new goal to reduce cancer death rates by at least 50 percent by 2047. Here’s the scoop on what the White House is calling its “moonshot” project. What is the cancer moonshot? Biden said he plans to “supercharge” the cancer program he oversaw five years ago as vice president. In…
