A judge blocked the FDA’s plan to regulate lab developed tests. What now?

One attorney said the ruling “isn’t quite the stake in the heart.” The FDA is unlikely to challenge the court’s decision, but Congress could still take on the issue.

By Susan Kelly • April 17, 2025

CDC panel mulls changes to COVID shot recommendations

The advisory committee, which met Tuesday for the first time since Robert F. Kennedy Jr. was sworn in as health secretary, also discussed the Texas measles outbreak.

By Delilah Alvarado • April 16, 2025

Health department layoffs may be illegal, experts say

HHS bypassed normal procedures as it laid off thousands of employees, according to sources. One union has already filed an internal complaint, while at least two law firms are exploring suits.

By Rebecca Pifer • April 15, 2025

Translating FDA guidance into action: Regulatory considerations for orphan drug developers

The rare disease drug landscape is evolving, with regulatory guidance shaping its future. Learn more.

April 14, 2025

FDA plans to phase out animal testing for some drugs

The initiative, which will start with monoclonal antibodies, is the first big regulatory shift from the FDA since Martin Makary was sworn in.

By Ned Pagliarulo • April 11, 2025

Biotech CEOs, VCs urge Cassidy, Senate to ease impact of FDA cuts

Experts say the layoffs are already causing issues in drug development — and things may get far worse without critical institutional knowledge at the FDA.

By Kristin Jensen • April 10, 2025

RFK Jr. won’t appear before Senate panel this week

HELP committee chair Bill Cassidy, R-La., had invited Kennedy to testify April 10 on the sweeping layoffs of federal health workers Kennedy ordered last month. A hearing could still take place later. 

By Ned Pagliarulo • April 7, 2025

FDA misses approval deadline for Novavax’s COVID-19 vaccine

The delayed decision comes amid a major organizational shakeup that included the departure of top vaccine official Peter Marks.

By Delilah Alvarado • April 3, 2025

‘A cruel April Fool’s joke’: HHS layoffs characterized by confusion, errors

The sweeping workforce reduction that began Tuesday was made worse by mistakes and poor communication, including directions for some CMS employees to contact a director who died last year.

By Rebecca Pifer • Updated April 2, 2025

FDA device office hit in HHS layoffs

Teams working on device communications and policy were cut from the agency on Tuesday, according to multiple FDA workers.

By Elise Reuter • April 2, 2025

HHS begins layoffs in chaotic fashion

Reduction-in-force notices went out Tuesday morning to employees across HHS. At FDA, OND director Peter Stein is departing as cuts hit CDER.

By Rebecca Pifer • April 1, 2025

Judge overturns FDA’s lab developed test regulation, siding with industry

A Texas judge vacated the FDA’s final rule, which was strongly opposed by the laboratory industry, and remanded the matter to HHS Secretary Robert F. Kennedy Jr.

By Susan Kelly • April 1, 2025

Cell, gene therapy makers lose a champion at FDA with exit of Peter Marks

Marks’ resignation leaves the field without a regulator many view as “integral” to its progress over the last decade.

By Ben Fidler • March 31, 2025

FDA official’s ouster sends shares of vaccine makers sliding

Shares in Moderna, Vaxcyte, Novavax and BioNTech all fell Monday after Peter Marks, head of the FDA office that reviews vaccines, resigned on Friday.

By Delilah Alvarado • March 31, 2025

Peter Marks, FDA’s top vaccine official, resigns

In his resignation letter, Marks cited disagreement with HHS Secretary Robert F. Kennedy Jr., who he said pushed “misinformation and lies.”

By Ned Pagliarulo • March 29, 2025

‘Everything is word of mouth’: HHS employees face uncertainty in looming Trump layoffs

Many HHS department heads and staff were unaware of plans to fire some 10,000 employees until they were publicly disclosed Thursday, sources said.

By Sydney Halleman , Ned Pagliarulo , Rebecca Pifer • March 28, 2025

HHS to cut 10,000 staff in major restructuring under RFK Jr.

The FDA will lose about 3,500 employees under the plans, although HHS said drug, medical device and food reviewers will not be affected.

By Ned Pagliarulo , Rebecca Pifer • Updated March 27, 2025

First Prader-Willi drug to reduce hunger approved by FDA

Clearance of Vykat unlocks what analysts anticipate will be a lucrative market opportunity for Soleno Therapeutics.

By Ben Fidler • Updated March 27, 2025

Makary confirmed by Senate as FDA commissioner

The Johns Hopkins surgeon will helm the agency as layoffs loom and important decisions on treatments for rare and infectious diseases await.

By Jonathan Gardner • March 26, 2025

FDA approves first-of-its-kind antibiotic from GSK

The drug is a needed new option for treating uncomplicated UTIs, a common infection that’s becoming harder to treat as rates of microbial resistance rise.

By Delilah Alvarado • March 26, 2025

Alnylam drug gets long-awaited FDA approval in deadly heart disease

Amvuttra’s clearance in a rare form of cardiomyopathy could help Alnylam turn a regular profit — if it can wrest control of a fast-changing market.

By Ben Fidler • Updated March 20, 2025

FDA sets flu shot recommendations without input of outside advisers

The agency formulated its advice to manufacturers after coordinating with the CDC and Defense Department. An advisory meeting that's typically held was canceled last month.

By Delilah Alvarado • March 14, 2025

Douglas Kelly, deputy science director at FDA’s device center, leaves agency

Kelly, who made several key hires at the CDRH and helped negotiate the last user fee agreement, announced his departure in a LinkedIn post Sunday.

By Elise Reuter • March 11, 2025

Following FDA cuts, Trump nominee Makary vows ‘independent’ staff review

The Johns Hopkins surgeon highlighted rapid growth at the agency, but pledged key staff will have “all the resources they need to do their job well.”

By Jonathan Gardner • March 6, 2025

Makary, under review to run FDA, evades pressure to reinstate canceled vaccine meeting

Questioned by senators at a Thursday hearing, President Trump's FDA nominee said he would reevaluate which scientific topics require an advisory committee's input.

By Ned Pagliarulo • March 6, 2025