FDA novel device clearances plummet in Q1

Today’s Big News

Mar 27, 2025

RFK Jr. cuts 4,700 FDA and NIH jobs as HHS eliminates ‘an entire alphabet soup of departments’ 


GSK tip claiming Pfizer delayed COVID vaccine results during 2020 election prompts US probe: WSJ 


FDA’s novel medical device clearances slow to a crawl 


Drugmakers fear Trump tariffs will drive up manufacturing costs, hurt medicine access: BIO survey 


Senior NIH leader Tara Schwetz put on leave: Stat 


Lilly adds Alzheimer’s disease care to DTC telehealth platform

 

Featured

RFK Jr. cuts 4,700 FDA and NIH jobs as HHS eliminates ‘an entire alphabet soup of departments’

The federal government is cutting 3,500 full-time FDA employees and 1,200 NIH workers as part of an overarching move designed to eliminate 10,000 jobs in the Department of Health and Human Services.
 

Top Stories

GSK tip claiming Pfizer delayed COVID vaccine results during 2020 election prompts US probe: WSJ

A former Pfizer-turned-GSK scientist reportedly told colleagues that Pfizer delayed the results of its COVID-19 vaccine trials, prompting an investigation as GSK brought the matter to federal prosecutors shortly after the recent election.

FDA’s novel medical device clearances slow to a crawl

According to the FDA’s public database, since the start of this year the agency has issued only two de novo clearances, far below its quarterly average.

Drugmakers fear Trump tariffs will drive up manufacturing costs, hurt medicine access: BIO survey

As President Donald Trump renewed his threat of potential pharmaceutical tariffs this week, trade group the Biotechnology Innovation Organization is warning of the fallout the additional duties could have on patients’ access to medicines.

Senior NIH leader Tara Schwetz put on leave: Stat

Tara Schwetz, Ph.D., a deputy director at the National Institutes of Health and overseer of ARPA-H's creation, has reportedly been put on administrative leave in the latest shake-up to the health agency’s leadership.

Lilly adds Alzheimer’s disease care to DTC telehealth platform

Eli Lilly is expanding its menu of direct-to-consumer healthcare offerings. The Big Pharma announced Thursday that its LillyDirect platform will now connect U.S. users to both in-person and virtual care options for Alzheimer’s disease.

Merck lays out subcutaneous Keytruda data in lung cancer amid patent brawl with Halozyme

Merck & Co.’s subcutaneous formulation of Keytruda has matched up to the original intravenous version on two blood concentration measurements, paving way for a potential FDA approval that could give patients a more convenient option of the widely used cancer drug.

Nkarta lays off 3rd of staff, including CFO, to fund autoimmune CAR NK program

Nkarta is laying off a third of its employees, including half of the biotech’s executive leadership, as the company diverts cash to its lead CAR NK candidate.

Chiesi unveils €430M investment to revitalize Italian production site for inhaler, biologics manufacturing

As part of an ongoing expansion strategy around the globe, Chiesi announced this week that it will invest 430 million euros (roughly $464 million) to build a new facility for inhalers and other health products in the Nerviano municipality of the Italian city of Milan, while also revitalizing a decades old production site there.

Langer spin-out Lyndra Therapeutics begins winding down operations, lays off staff

Lyndra Therapeutics, which spun out of Moderna co-founder Robert Langer’s lab at the Massachusetts Institute of Technology in 2015, is winding down operations this week, a person with knowledge of the situation told Fierce Biotech.
 
Fierce podcasts

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A closer look at pharma’s top patent losses in 2025

This week on "The Top Line," we explore the potential impacts of this year's sizable patent cliff on the pharma industry at large.
 

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