FDA/CDC
FDA/CDC
FDA approves second antiamyloid for Alzheimer’s disease
Like its controversial cousin aducanumab, lecanemab was approved under the FDA’s accelerated approval pathway.
FDA/CDC
FDA approves first-in-class drug for HIV
FDA has approved the medication lenacapavir (Sunlenca) for adults living with multidrug resistant HIV-1 infection.
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...
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.”