FDA/CDC
News
FDA pulls U.S. authorization for Eli Lilly’s COVID drug bebtelovimab
The drug is not expected to neutralize the dominant BQ.1 and BQ.1.1 subvariants of Omicron.
FDA/CDC
With type 1 diabetes delay possible, focus now on screening
The FDA approval of teplizumab for the delay of type 1 diabetes highlights the need to cost effectively identify those at risk who could...
News
FDA approves first-ever agent to delay type 1 diabetes onset
Teplizumab delayed progression to clinical type 1 diabetes by about 2 years compared with placebo in individuals destined to develop the condition...
FDA/CDC
FDA grants accelerated approval for new treatment of female cancers
Eligible patients for mirvetuximab soravtansine include those with folate receptor alpha, chemo resistant ovarian, fallopian and peritoneal...
FDA/CDC
New CDC guidance on prescribing opioids for pain
New evidence has emerged regarding the benefits and risks of prescription opioids for acute and chronic pain.
FDA/CDC
FDA approves self-administered, SubQ furosemide preparation
The preparation of the common loop diuretic is said to provide “intravenous-equivalent” dosing for outpatients with heart failure and volume...
Latest News
Doctors urge FDA to add miscarriage management to abortion pill labels
Mifepristone, in combination with misoprostol, induces an abortion up to 10 weeks into a pregnancy.
FDA/CDC
ALS drug gets FDA panel thumbs-up after rare second look
FDA officials in the meeting stressed the importance of considering unmet medical need in ALS in the panel’s decision-making process.
Latest News
Eighty percent of U.S. maternal deaths are preventable: Study
“It’s significant. It’s staggering. It’s heartbreaking.”
FDA/CDC
FDA authorizes updated COVID boosters to target newest variants
The agency cited data to support the safety and efficacy of this next generation of mRNA vaccines targeted toward variants of concern.