Boehringer Ingelheim drug wins FDA OK in tough-to-treat lung disease

The clearance makes Jascayd the first new drug for idiopathic pulmonary fibrosis in over a decade, but some analysts see it as a “modest” advance in care.

By Delilah Alvarado • Oct. 8, 2025

Peter Marks, former top FDA vaccine official, joins Eli Lilly

Six months after his abrupt resignation as CBER director, Marks has been hired to run discovery and infectious disease work at the big Indianapolis drugmaker.

By Jonathan Gardner • Oct. 7, 2025

As shutdown begins, FDA to stop accepting new drug submissions

The funding lapse triggered by the U.S. government shutdown is the latest test for an agency that’s already dealt with significant layoffs and leadership upheaval this year.

By Kristin Jensen • Oct. 1, 2025

FDA official’s comments spark Aurinia sell-off; Halozyme buys a biotech

George Tidmarsh criticized Aurinia’s lupus drug in a later-retracted social media post. Elsewhere, the FDA approved a new Novartis drug and two biotechs cut staff.  

By BioPharma Dive staff • Oct. 1, 2025

Lilly’s oral SERD gets FDA nod in advanced breast cancer

The clearance of Inluriyo is another development among a group of oral medicines aiming to supplant a widely used, injectable type of hormone therapy.

By Ben Fidler • Sept. 25, 2025

Scholar Rock SMA drug rejected by FDA over manufacturing concerns

The denial sets back a drug Scholar Rock hopes to become part of a new standard of care for spinal muscular atrophy, treatment for which has changed dramatically over the last decade.

By Ben Fidler • Sept. 23, 2025

FDA clears first Barth syndrome drug amid scrutiny of rare disease stance

After an earlier rejection that drew criticism from some observers, the FDA quickly accepted Stealth BioTherapeutics’ new application and cleared its drug’s use.

By Ben Fidler • Sept. 22, 2025

Prasad regains role as FDA’s top doctor, scientist

An HHS spokesperson confirmed Prasad's reappointment as chief medical and scientific officer, one month after his surprising return to the agency as CBER director.

By Ned Pagliarulo • Sept. 11, 2025

FDA shares guidance to drugmakers developing non-opioid pain medicines

The agency says it’s open to offering speedy approval pathways for new pain medications that can fight the ongoing opioid addiction crisis.

By Kristin Jensen • Sept. 11, 2025

FDA clears J&J’s drug-device combo for bladder cancer

J&J executives have said they expect the therapy, Inlexzo, to become a future blockbuster and generate sales that significantly outstrip Wall Street forecasts.

By Jonathan Gardner • Sept. 10, 2025

New Summit data clouds approval pathway in lung cancer

A combination of ivonescimab and chemo didn’t extend survival over chemo alone in a global trial, missing a key goal often emphasized by regulators.

By Jonathan Gardner • Sept. 8, 2025

FDA outlines new review pathway for drugs treating ultra-rare diseases

The agency's two main review offices will work together to flexibly evaluate medicines for serious conditions that affect fewer than 1,000 people in the U.S.

By Ned Pagliarulo • Sept. 4, 2025

FDA approves updated COVID boosters, but narrows use

While the agency cleared vaccines from Pfizer, Moderna and Novavax broadly in older adults, it restricted eligibility in younger people to those with underlying health conditions.

By Delilah Alvarado • Updated Aug. 27, 2025

Why an FDA decision on Stealth’s Barth drug could ripple through the rare disease field

Stealth secured a new agency review of its experimental therapy elamipretide after a rejection this year. The result could carry broader consequences.

By Alexandra Pecci • Aug. 26, 2025

FDA suspends license for Valneva’s chikungunya shot

The agency said it had become aware of more reports of serious adverse events, leading center director Vinay Prasad to conclude the vaccine is no longer safe for its intended use.

By Delilah Alvarado • Aug. 25, 2025

FDA’s new accelerated pathway may open pharma up to risks, as well as benefits

Faster review times could leave drugmakers vulnerable to litigation, while new Trump administration priorities add more uncertainty to the approval process.

By Amy Baxter • Aug. 25, 2025

Stealth resubmits rare disease drug to FDA

The biotech, which cut jobs following the rejection in May of its Barth syndrome therapy, claimed it has addressed the agency’s concerns and now sees potential for a speedy review.

By Jonathan Gardner • Aug. 18, 2025

Novo’s Wegovy becomes first GLP-1 drug approved for MASH

The FDA clearance sets Novo’s medicine up for a market battle with Madrigal Pharmaceuticals’ fast-selling Rezdiffra.

By Ben Fidler • Aug. 18, 2025

With FDA PreCheck, drugmakers may get a manufacturing boost

The newly announced program targeting domestic manufacturing is the latest Trump administration move to ramp up drugmaking in the U.S.

By Amy Baxter • Aug. 13, 2025

Insmed gains US approval of lung disease drug forecast to be blockbuster

Brinsupri, which Insmed acquired from AstraZeneca nearly a decade ago, is the first treatment for bronchiectasis that’s not caused by cystic fibrosis. 

By Jonathan Gardner • Aug. 12, 2025

Vinay Prasad, in surprise reversal, to rejoin FDA after abrupt departure

One analyst speculated that, going forward, Prasad may be less “heavy-handed” in reviewing rare disease therapies given the public backlash to the agency’s confrontation with Sarepta.

By Ben Fidler • Updated Aug. 11, 2025

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