FDA to start new ‘precheck’ program to boost US drug production

The initiative is a response to a Trump administration order to speed the construction of the type of new drug factories many pharmaceutical companies have promised to build.

By Ben Fidler • Aug. 7, 2025

FDA lifts pause on Valneva’s chikungunya shot, but adds new limits

The FDA had halted use in older adults while it investigated reports of side effects. The vaccine’s label now carries new warnings and restricts vaccination to individuals at high risk of infection.

By Delilah Alvarado • Aug. 7, 2025

Vinay Prasad’s ouster leaves biotech guessing at FDA direction

The abrupt exit of the former CBER director raises questions about the FDA’s leadership. For now, newly appointed CDER head George Tidmarsh will take over Prasad’s post.

By Ben Fidler • Updated July 30, 2025

Vinay Prasad, controversial FDA official, abruptly departs agency

Prasad's exit ends a tumultuous tenure during which he led a reworking of agency guidelines on COVID vaccines and his office got embroiled in controversy over a Duchenne gene therapy.

By Ben Fidler • July 29, 2025

FDA allows Sarepta to resume some Elevidys shipments

Wall Street analysts suggested the FDA’s unexpected change in stance might reflect pressure from advocacy groups and a rebuke from higher-ups in the Trump administration.

By Ned Pagliarulo , Ben Fidler • Updated July 29, 2025

FDA delays approval decision for Bayer menopause therapy

The agency told Bayer it needs additional time to review the non-hormonal drug, called elinzanetant. Regulators in Canada and the U.K. have already cleared it for use.

By Delilah Alvarado • July 25, 2025

FDA panel elevates concerns over antidepressant use during pregnancy

Experts on the panel shared many of the same views around SSRIs, arguing the risks of the drugs during pregnancy are greater than currently accepted.

By Delilah Alvarado • July 22, 2025

Sarepta stops Elevidys shipments after standoff with FDA

Company CEO Doug Ingram said the pause was necessary for Sarepta to maintain a "productive and positive working relationship" with the regulator.

By Ned Pagliarulo • July 21, 2025

Former biotech executive appointed to lead FDA drug office

George Tidmarsh, a Stanford University physician who founded Horizon Pharma and later ran La Jolla Pharma, was named head of the Center for Drug Evaluation and Research.

By Ned Pagliarulo • July 21, 2025

5 questions on Sarepta, the FDA and a Duchenne gene therapy crisis

While Sarepta has now consented to the FDA’s request to stop selling Elevidys, the company’s brief standoff with the agency could still carry major consequences for the Duchenne community.

By Ben Fidler , Ned Pagliarulo • Updated July 22, 2025

FDA asks Sarepta to stop shipping Duchenne gene therapy

The company refused the FDA’s request and will continue shipping its therapy, Elevidys, to Duchenne patients who can still walk. A pause on shipments to older, non-ambulatory patients remains in place.

By Ned Pagliarulo • Updated July 19, 2025

Panel urges FDA to remove warnings on hormonal menopause therapy

A meeting held by the FDA Thursday spotlighted debate over black box warnings that have limited use of hormone treatment for hot flashes.

By Delilah Alvarado • July 18, 2025

Moderna’s latest approval again reveals FDA rift over COVID vaccines

Vinay Prasad overruled other reviewers for a third time in recent months in clearing only narrow use of Moderna's vaccine in young children. 

By Delilah Alvarado • July 16, 2025

FDA turns back Capricor’s Duchenne cell therapy

The company said it was “surprised” by the decision, which followed the ouster of cell and gene therapy officials from the agency during deramiocel’s review.

By Ben Fidler • July 11, 2025

Moderna COVID vaccine gets full approval for children

The approval comes amid regulatory upheaval under HHS head Robert F. Kennedy Jr., who has pushed for changes around mRNA vaccines in particular.

By Delilah Alvarado • Updated July 11, 2025

FDA, in policy shift, publishes some drug rejection letters

The agency disclosed a tranche of more than 200 complete response letters from the past five years, but only those involving medicines that it later cleared.

By Ned Pagliarulo • July 10, 2025

Novartis gets approval of first malaria medicine for newborns

Coartem Baby, which was cleared by health authorities in Switzerland, will fill an important gap in treatment. Novartis plans to sell it “largely” on a not-for-profit basis.

By Delilah Alvarado • July 8, 2025

After delay, Kalvista wins FDA OK for drug to treat rare swelling disorder

The company had blamed FDA "resource constraints" for the delay, while a rival drug for hereditary angioedema received an on-time approval.

By Jonathan Gardner • July 7, 2025

FDA takes major step to ease access to CAR-T therapy

The agency removed some onerous requirements for the complex cancer drugs and reduced restrictions on patients’ post-treatment movement.

By Ned Pagliarulo • June 27, 2025

Top drug official at FDA reportedly set to exit next month

Jacqueline Corrigan-Curay, who serves as acting head of the powerful CDER office, will leave after nearly a decade at the agency.

By Ned Pagliarulo • June 23, 2025

Gene therapy faces fresh uncertainty as two more top FDA officials depart

The reported dismissal of high-ranking CBER officials Nicole Verdun and Rachael Anatol resurfaced lingering concerns about how gene therapies will be regulated under new FDA leadership.

By Ben Fidler • June 20, 2025

Could the FDA take an indirect approach to regulate lab developed tests?

Attorneys said many questions remain about test regulation after the FDA lost its legal fight. A recent warning letter could be a clue to future enforcement.

By Susan Kelly • June 16, 2025

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