FDA sets stricter approval standards for COVID vaccines

The agency will now require randomized, controlled data before approving new COVID shots for healthy children and adults, Commissioner Martin Makary and top vaccine official Vinay Prasad wrote in NEJM.

By Delilah Alvarado • Updated May 20, 2025

Novavax’s COVID vaccine gets FDA approval, but with limits

While the clearance is only for use in certain groups, Novavax’s long-awaited OK is still seen by analysts as a “win” for the company.

By Delilah Alvarado • May 19, 2025

FDA OKs first blood test to aid Alzheimer’s diagnosis

The FDA cleared the test for early detection of amyloid plaques associated with Alzheimer’s in people aged 55 years and older with signs and symptoms of the disease.

By Nick Paul Taylor • May 19, 2025

FDA delays approval decision for Biohaven rare disease drug

Shares of the biotech fell around 15% on news the FDA is not only taking longer to review the drug, but will assemble an outside group of advisers to evaluate it as well.

By Jacob Bell • May 15, 2025

Abeona sells speedy drug review voucher for $155M

The biotech has quickly turned a cell therapy approval into one of the more lucrative recent sales for a priority review voucher, which companies can use to fast track drug reviews.

By Ben Fidler • May 12, 2025

Biotech is guessing how Vinay Prasad might change the FDA. His research, writing offer clues.

CBER’s new chief has argued for more stringent measures of assessing drugs for cancer and rare diseases, suggesting he might push for higher standards in the review of medicines under his division's purview.

By Jonathan Gardner • May 8, 2025

FDA set to meet this month on COVID vaccines

The advisory committee meeting is an important step in the process of readying boosters for the fall and winter season, but will take place amid newly imposed scrutiny of COVID shots.

By Delilah Alvarado • May 7, 2025

Prasad’s FDA appointment pressures cell and gene therapy stocks

A vocal opponent of his predecessor Peter Marks, Vinay Prasad will now lead the office tasked with reviewing some genetic medicines, adding more uncertainty to an already struggling field of research.

By Ben Fidler • May 6, 2025

Vinay Prasad, a physician and FDA critic, to lead agency center overseeing vaccines

Prasad has gained a reputation for questioning U.S. health policy and accelerated approvals in oncology, and has also opposed some vaccine mandates and the use of COVID shots in children.

By Ben Fidler , Jonathan Gardner • May 6, 2025

FDA layoffs could slow safety communications, experts warn

The mass cuts, which included communications staff, could slow public notices on medical device recalls and other safety alerts.

By Elise Reuter • May 6, 2025

Moderna combination flu, COVID shot delayed amid FDA scrutiny

Additional data required by the FDA are the latest evidence of what one analyst described as a “higher bar” for vaccines.

By Delilah Alvarado • May 1, 2025

FDA misses approval deadline for biotech’s rare disease drug

The delay for Stealth Biotherapeutics comes amid a heightened focus on the impact FDA job cuts might have on drug reviews.

By Gwendolyn Wu • Updated April 29, 2025

Abeona cell therapy approved by FDA for rare skin condition

Zevaskyn, which Abeona priced at $3.1 million, treats epidermolysis bullosa. It will compete with a gene therapy from Krystal Biotech that is off to a strong sales start.

By Ben Fidler • April 29, 2025

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