News
FDA Commissioner Marty Makary intends to resign on Tuesday, according to several sources. This report follows a tumultuous 13-month tenure in which Makary oversaw the controversial rejections of several rare disease drugs and “predictable volatility” within the agency.
FEATURED STORIES
New guidelines from two leading medical associations suggest that efforts to reduce bad cholesterol should focus on maintaining low levels of two key lipoproteins. Big pharma is all in, looking to improve on the standard statins to help vanquish America’s number one killer: heart disease.
The FDA’s decision last year to make complete response letters public provides new insight into why therapies sometimes fail to get the regulatory greenlight. Analysts say the information could help sponsors refine their regulatory strategies.
The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Robert F. Kennedy Jr.’s health department has consistently touted radical transparency as being key to its mission. Recent instances—the FDA’s decision not to disclose the recipients of three Commissioner’s National Priority Vouchers and FDA and CDC choices not to publish vaccine-related papers—call this intent into question.
THE LATEST
The FDA is looking for stronger overall survival data to back Actinium’s application for Iomab-B, an investigational therapy that will allow acute myeloid leukemia patients to receive bone marrow transplants.
Whether they’re newly minted managers or C-suite executives, effective managers often lead with empathy, intellectual curiosity and vulnerability.
With the late-stage win, Bayer announced Monday that it plans to talk to regulators about seeking approval in an indication that is central to its $3 billion-plus peak sales forecast.
As part of a pipeline realignment, Bristol Myers Squibb is returning the rights to Agenus for its proprietary TIGIT bispecific antibody program and terminating their 2021 license, development and commercialization agreement.
BioNTech on Monday reported nearly $885 million in losses in the second quarter of 2024, compared to $208.5 million during the same period last year.
All doses of Eli Lilly’s type 2 diabetes medication Mounjaro and weight-loss drug Zepbound are now available, according to an update on Friday to the FDA’s drug shortage database.
An FDA advisory committee agreed on Friday that Zevra Therapeutics had provided sufficient efficacy data supporting the approval of arimoclomol for Niemann-Pick disease type C.
Despite having an impressive roster of high-profile supporters, including AbbVie, BMS, J&J, Novartis and Pfizer, PARP-focused Ribon has called it quits after nearly a decade in business.
Longeveron and Lexeo Therapeutics are working on CGT therapies to treat Alzheimer’s disease, but it’s not clear whether they have a better chance of success than traditional approaches.
Active immune therapies hold promise for preventing or slowing disease onset, but some experts warn of potential safety risks.