STAT4d
FDA clinical trial inclusivity guidelines will be back
Following the president’s recent executive order dismantling diversity, equity, and inclusion policies, the main page for the ...
LIB Therapeutics Announces FDA Acceptance of Biologics License Application for Lerodalcibep to Lower LDL-Cholesterol Across Broad Patient Population
LIB Therapeutics Inc. (LIB), a privately-held, late-stage biopharmaceutical company today announced the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License ...
STAT10d
With little fanfare, Biden administration stacked vaccine advisory committee with new members
With little fanfare, the Biden administration stacked a critical committee that helps set U.S. vaccination policy with new ...
Insurer Denies Access To Drugs Granted Accelerated Approval By FDA
Going forward, we may see more instances in which insurers deny or (temporarily) severely restrict coverage of accelerated ...
pharmaphorum3d
FDA starts review of first bronchiectasis drug candidate
The FDA has started a priority review of Insmed's brensocatib, which is pitching to become the first approved therapy for ...
Stricter abortion laws may cause increased infant deaths − 2 maternal and child health researchers explain the data
Infant mortality in the U.S. has increased by 7% since the 2022 Dobbs v. Jackson U.S. Supreme Court decision overturned the ...
The American Journal of Managed Care7d
OIG Report Seeks Better Oversight, Records for FDA’s Accelerated Approvals
Amid the uproar over the firing of 18 inspectors general, a report offering a coda to the aducanumab approval episode has ...
What to Expect from Robert F. Kennedy Jr.’s Confirmation Hearings
If confirmed by the Senate, Kennedy would head the Department of Health and Human Services (HHS), which oversees many of the ...
The American Journal of Managed Care14d
FDA Approves New Maintenance Dosing for Lecanemab to Treat Early-Stage Alzheimer Disease
The FDA approves a new maintenance dosing regimen for lecanemab (Leqembi; Eisai) in patients with early-stage Alzheimer ...
Here's What RFK Jr. Can and Can't Do if Confirmed as HHS Chief
President Trump said he would take health agencies in a new direction on the campaign trail and has chosen some controversial nominees to help him achieve his goal, including Robert F. Kennedy Jr., ...
federalnewsnetwork.com12d
FDA’s accelerated approval pathway has a few potholes
The Health and Human Services Office of Inspector General has found that, in a few cases, FDA officials veered from the accelerated approval pathway.
FierceBiotech10d
FDA digital director Troy Tazbaz departs the agency
The head of the FDA’s artificial-intelligence-focused Digital Center of Excellence, Troy Tazbaz, is departing the agency during what he described as the early stages of a “technological ...