Halozyme sues Merck; FDA blames cuts for Vanda delay

Halozyme claims Merck infringed on patents in developing a subcutaneous form of Keytruda. Elsewhere, Vanda’s challenge to an FDA rejection dragged on, while Sanofi revealed an immune drug setback. 

By BioPharma Dive staff • April 25, 2025

RFK Jr. is remaking HHS. Track the changes here.

Following an executive order from President Trump, the FDA plans to “aggressively deploy its available enforcement tools” to police direct-to-consumer drug ads.

By BioPharma Dive staff • Updated Aug. 28, 2025

Novo says it’s submitted obesity pill for FDA approval

A spokesperson confirmed the Danish drugmaker has asked U.S. regulators to clear an oral version of its weight loss drug Wegovy two years after reporting initial Phase 3 results.  

By Jonathan Gardner • April 21, 2025

Sanofi, Regeneron win FDA nod for Dupixent in chronic hives

The partners overcame an earlier rejection to win a seventh use for Dupixent, though some analysts are skeptical of its sales potential compared to other emerging medicines for the condition.

By Ben Fidler • April 18, 2025

Makary seeks to limit industry’s role in FDA advisory panels

Commissioner Martin Makary said the agency would, whenever possible, restrict drug company employees from participating as industry representatives on advisory committees.

By Ned Pagliarulo • Updated April 18, 2025

FDA cuts outlined in draft HHS budget

The leaked budget draft, if approved by Congress, would reduce the FDA’s budget authority, indicating more disruption could be in store for an agency already shaken by large-scale layoffs.

By Elise Reuter • April 18, 2025

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 Parduhn • 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 Parduhn • 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 Parduhn • 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 Parduhn • 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 Parduhn • 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