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

In a statement, CMS said it would broaden coverage for the amyloid-targeting therapy and reimburse treatment when patients and physicians participate in a data-collecting registry.

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 conditional clearance for Sarepta’s Elevidys in 4- and 5-year-olds is a milestone for research into the deadly disease, but raises the stakes of an ongoing trial that could prove how well it works.

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

FDA delays decision on GSK bone cancer drug acquired in $2B buyout

GSK said it remains confident in its application supporting the myelofibrosis medicine momelotinib, which it bought in last year’s deal for Sierra Oncology.

By Christopher Newman • June 16, 2023

FDA advisers endorse updating COVID shots to match circulating virus strain

The expert panel recommended coronavirus vaccines be tailored to target an omicron subvariant known as XBB, which Pfizer, Moderna and Novavax said they’re prepared to do.

By Delilah Alvarado • June 16, 2023

Roche follows AbbVie with FDA approval for dual-targeting lymphoma drug

The approval of Columvi adds another “bispecific antibody” to the market, highlighting progress for drugs that target two proteins rather than one.

By Ben Fidler • Updated June 20, 2023

FDA panel backs full approval for Eisai, Biogen Alzheimer’s drug

In a 6-0 vote Friday, agency advisers agreed recent clinical trial data confirmed the drug’s benefit, paving the way for an FDA decision early next month.

By Jacob Bell • Updated June 9, 2023

FDA sets decision dates for Vertex, CRISPR gene editing drug

The regulator will issue separate verdicts on the pioneering treatment’s use in sickle cell disease and beta thalassemia, with the first expected late this year.

By Christopher Newman • June 9, 2023

FDA advisers back RSV antibody drug for use in infants

The positive panel vote for AstraZeneca and Sanofi’s treatment is the latest development in a flurry of regulatory activity that’s brought forward new options for preventing RSV-related respiratory disease.

By Delilah Alvarado • June 9, 2023

Ahead of key meeting, FDA appears open to full approval of Alzheimer’s drug Leqembi

Agency advisers are meeting Friday to discuss whether recent trial data confirm Leqembi’s benefit. A vote is expected in the late afternoon. 

By Jacob Bell • June 7, 2023

FDA staff appear supportive of RSV drug from AstraZeneca, Sanofi

Agency scientists raised no major red flags in their review of the antibody medicine in documents posted ahead of a Thursday meeting of FDA advisers.

By Delilah Alvarado • June 6, 2023