FDA to miss approval deadline for Kalvista drug due to ‘resource constraints’

A “heavy workload” and “limited resources” have left the agency unable to meet a June 17 deadline to approve a therapy Kalvista has been developing for hereditary angioedema. 

By Ben Fidler • June 16, 2025

Moderna wins FDA OK to widen use of RSV vaccine

The agency’s decision to clear Moderna’s shot for use in certain younger adults is a much-needed win for a company that’s been significantly impacted by the recent changes in FDA and HHS leadership.

By Delilah Alvarado • June 13, 2025

FDA clears Nuvation lung cancer drug, setting up battle with Bristol Myers and Roche

The drug, Ibtrozi, will now vie for market share in an indication where multiple large pharmaceutical companies have already struggled to grow sales.

By Ben Fidler • June 11, 2025

Merck antibody drug for RSV approved by FDA

Known as Enflonsia, the drug will compete for market share with Sanofi and AstraZeneca’s in-demand Beyfortus, which quickly became a blockbuster medicine following its approval two years ago.

By Delilah Alvarado • June 9, 2025

FDA meeting gives window into gene therapy field’s angst

Gene therapy experts and advocates warning of the sector’s many challenges found a receptive audience in FDA leadership at a regulatory forum Thursday.

By Ned Pagliarulo • June 6, 2025

FDA’s AI tool ‘Elsa’ is here, and the industry has questions

The agency has provided only limited details about its AI pilot as it advances an “aggressive timeline” for the tool's rollout.

By Amy Baxter • June 5, 2025

FDA clears Moderna’s new COVID vaccine, but with limits

The shot, dubbed mNexspike, is approved for older adults and people whose health conditions put them at higher risk of severe disease. 

By Delilah Alvarado • May 31, 2025

Merck, Daiichi pull approval application for ADC in lung cancer

A therapy at the center of their $22 billion alliance failed to extend survival in a type of lung tumor, leading the companies to abandon a U.S. submission.

By Ben Fidler • May 29, 2025

FDA leaders seek industry input on ‘listening tour’

Commissioner Martin Makary and two of his deputies aim to meet with drugmaker CEOs to discuss how the agency can “modernize” regulations.

By Ned Pagliarulo • May 28, 2025

FDA sets COVID vaccine formula as RFK Jr. narrows guidance for shots

The agency recommends manufacturers update their vaccines to target the JN.1 strain. At the same time, HHS head Robert F. Kennedy Jr. is removing guidance that healthy children and pregnant women receive COVID shots.

By Delilah Alvarado • Updated May 27, 2025

FDA panel recommends keeping COVID shots targeted to same strain as last year

The advisory committee, which met after the agency rolled out new vaccine guidelines, said companies should tailor their booster doses to the “JN.1” coronavirus lineage.

By Delilah Alvarado • May 22, 2025

FDA panel backs Darzalex for early stage multiple myeloma

Agency drug reviewers had questioned patient risk criteria and the efficacy endpoint used in a key trial supporting J&J's drug.

By Jonathan Gardner • May 21, 2025

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