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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.
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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.
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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.
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Corcept Therapeutics’ amyotrophic lateral sclerosis drug was linked to an 87% reduction in the risk of death, a result the biotech hopes to replicate in an upcoming Phase 3 trial.
Katherine Szarama, who has served as Prasad’s deputy at the Center for Biologics Evaluation and Research since December, joins a long list of temporary leaders at the Department of Health and Human Services.
On the heels of several big buys, Merck still has eyes for M&A—particularly in the oncology, immunology and cardiometabolic spaces—as the quest continues for a candidate that can top Keytruda.
Foundayo became available on April 9 and has already reached 20,000 patients as Eli Lilly builds its marketing machine for the weight loss pill.
UniQure plans to submit AMT-130 to the U.K.’s Medicines and Healthcare products Regulatory Agency in the third quarter of 2026 based on Phase 1/2 data showing a 75% slowing of disease—the same data the FDA has deemed unacceptable for a biologics license application.
After delaying a late-stage readout last year due to “irregularities” at certain study sites, pivotal data for Bristol Myers Squibb’s Cobenfy appear set to arrive later this year.
Eli Lilly’s $19.8 billion revenue for the first quarter could have been higher if not for declining prices for key medicines like Zepbound, Mounjaro and Taltz.
The patient death occurred outside the U.S. and was deemed unrelated to Newron Pharmaceuticals’ investigational schizophrenia drug.
While AstraZeneca has discontinued work on four assets—including one in asthma and another in acromegaly—the pharma has also elected to take forward a bispecific antibody that destroys the EGFR protein.
Over the last two years, Alector has suffered three setbacks for its neurodegenerative disease pipeline, often forcing the company to downsize.