FDA delays decision on Valneva’s chikungunya vaccine

The agency needs more time to settle with Valneva the design of a post-marketing study for the shot, which could become the first preventive therapy for chikungunya available in the U.S.

By Delilah Alvarado • Aug. 14, 2023

J&J joins PARP rivals with narrow FDA clearance in prostate cancer

The agency approved Akeega only for patients with BRCA mutations — another limited OK for a class of drugs that have come under regulatory scrutiny.

By Ben Fidler • Aug. 14, 2023

Iveric drug approved for type of vision loss as rival’s safety draws scrutiny

The FDA's clearance of Izervay for geographic atrophy comes as rare side effects have overshadowed the fast launch of a competing treatment from Apellis.

By Ben Fidler • Aug. 5, 2023

GSK broadens use of cancer immunotherapy with latest FDA OK

The pharma’s drug Jemperli was cleared for patients with newly diagnosed endometrial tumors, but could soon face competition from Merck’s Keytruda.

By Jonathan Gardner • Aug. 1, 2023

With OTC birth control approved, access battles have just begun

Perrigo received the first FDA approval for an over-the-counter birth control pill. Now, its global VP of women’s health says the company is working on the next challenge — affordability.  

By Karissa Waddick • July 31, 2023

FDA declines to review Biohaven’s latest drug in setback to pipeline

While the FDA doesn’t think the brain disease treatment merits an evaluation, Biohaven is still pushing for one and has requested a further meeting.

By Delilah Alvarado • July 27, 2023

Wilson Bryan, former FDA gene therapy leader, joins consulting firm

The agency veteran, who led the Office of Tissues and Advanced Therapies during a boom in gene and cell therapy research, retired in March.

By Ned Pagliarulo • July 19, 2023

FDA approves new RSV drug to protect infants, toddlers

Developers AstraZeneca and Sanofi expect to make the preventive antibody treatment, called Beyfortus, available ahead of the upcoming cold season.

By Delilah Alvarado • July 17, 2023

First nonprescription birth control pill approved by FDA

The oral contraceptive’s maker, Perrigo, said the pill will be available in drug and grocery stores early next year, but did not disclose its planned price.

By Delilah Alvarado • July 13, 2023

Takeda withdraws FDA approval application for dengue vaccine

While the shot is approved in the EU, Takeda wasn’t able to address data collection issues raised by the U.S. regulator in its current review cycle.

By Delilah Alvarado • July 11, 2023

FDA grants Eisai’s Leqembi full approval, opening door to wider use of Alzheimer’s drug

The broader approval was seen as necessary to drive insurers, namely Medicare, to increase coverage of so-called amyloid-targeting therapies.

By Jacob Bell • Updated July 7, 2023

Moderna, chasing GSK and Pfizer, brings RSV vaccine to regulators

The vaccine has a chance to become Moderna’s second approved product and could help offset declining sales for its COVID-19 shot.

By Kristin Jensen • July 5, 2023

BioMarin finally secures FDA approval of hemophilia gene therapy

After a prolonged journey, the medicine, known as Roctavian, is now cleared for certain patients with hemophilia A, the more common form of the rare bleeding disorder.

By Jacob Bell • June 29, 2023

Ipsen gains FDA panel backing for bone drug acquired in $1.3B buyout

Despite hesitations, an advisory committee recommended use of the drug — a medicine Roche once developed for lung diseases — to treat the rare condition fibrodysplasia ossificans progressiva. 

By Delilah Alvarado • June 29, 2023

Alvotech to raise cash after third FDA rejection for Humira biosimilar

The latest regulatory setback, tied to continuing manufacturing issues, ensures Alvotech and partner Teva won’t be able to launch their drug alongside a wave of emerging Humira copycats.  

By Kristin Jensen • June 29, 2023

FDA rejection sets back Regeneron’s plan to defend top-selling eye drug

A manufacturing issue led the agency to turn back an application for a high-dose form of Eylea, surprising analysts and delaying a launch the company is relying on to answer a competitive threat from Roche.  

By Kristin Jensen • June 28, 2023

Pfizer’s hemophilia B gene therapy inches closer to regulatory approval

The treatment could become Pfizer’s first marketed gene therapy, an area the pharma has poured significant resources into in recent years.

By Delilah Alvarado • June 27, 2023

5 FDA decisions to watch in the third quarter

By the end of September, the FDA will hold two anticipated advisory meetings and issue important decisions on drugs for Alzheimer’s, depression and a type of vision loss. 

By Ben Fidler , Jacob Bell , Delilah Alvarado • June 26, 2023

Top FDA official overruled review team in approval of Sarepta’s Duchenne gene therapy

In a memo made public Friday, Peter Marks, head of the agency office that oversees gene therapies, wrote that he disagreed with other reviewers and saw “compelling” evidence to clear Elevidys.

By Ben Fidler • June 23, 2023

Medicare has no surprises in planned registry for new Alzheimer’s drugs

Ahead of Leqembi’s possible full approval next month, the agency released details emphasizing how the required registry to track patient outcomes will be free and easy to use.

By Christopher Newman • June 23, 2023

Intercept to abandon NASH research, lay off staff after FDA drug rejection

The FDA for the second time turned back Intercept’s application for approval of its drug obeticholic acid in the liver disease, spurring the restructuring.

By Ben Fidler • June 23, 2023

First Duchenne gene therapy approved by FDA for young children

The approval of Elevidys was a milestone for research into the progressive and deadly disease. But the subsequent failure of a confirmatory trial has raised questions for the FDA.

By Ben Fidler • Updated June 22, 2023

Pfizer’s PARP drug follows Lynparza with narrow clearance in prostate cancer

As with Merck and AstraZeneca’s medicine, the agency has only cleared Talzenna for use in a subset of newly diagnosed patients who appear most likely to benefit from treatment.

By Jonathan Gardner • June 21, 2023

Bluebird, playing catch-up, gets decision date for sickle cell gene therapy

The FDA will issue a decision on lovo-cel by Dec. 20, roughly two weeks after a verdict is expected on a rival treatment from Vertex and CRISPR Therapeutics. 

By Kristin Jensen • June 21, 2023

Patient death spurs FDA to pause test of Arcellx’s Gilead-partnered cell therapy

The company said limitations on “bridging treatment” used to hold cancer in check could be to blame, and is working to change the study’s protocol.

By Jonathan Gardner • June 20, 2023