FDA: Page 2
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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 -
New Alzheimer's drugs
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 -
National Institute of Allergy and Infectious Diseases. (2017). "Human Respiratory Syncytial Virus" [Micrograph]. Retrieved from Flickr.RSV vaccines
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 -
Ermath, Michael. (2020). "Individualized Therapies Workshop" [Photograph]. Retrieved from Flickr.
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 -
New Alzheimer's drugs
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 -
New Alzheimer's drugs
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 -
Gene editing
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