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

FDA sets advisory meeting date for Brainstorm’s ALS cell therapy

Having taken the rare step of filing for approval over protest, Brainstorm will get another chance to make a case for its drug NurOwn during a Sept. 27 meeting of cell, tissue and gene therapy experts.

By Jacob Bell • June 6, 2023

Medicare keeps limits on Alzheimer’s drug coverage, but loosens policy

The agency will reimburse Alzheimer’s treatments like Eisai and Biogen’s Leqembi if they receive full FDA approval, but plans to still require data collection via a patient registry.

By Christopher Newman • June 1, 2023

FDA clears narrow use of Lynparza in early prostate cancer, continuing ‘shift’ on PARP drugs

The regulator’s decision to approve the drug only for patients with BRCA mutations “increasingly confirms” the changing perception of PARP blockers, one analyst said.

By Ben Fidler • June 1, 2023

Pfizer’s RSV vaccine wins FDA approval in older adults

The shot’s clearance comes several weeks after the regulator made GSK’s Arexvy the first vaccine for RSV in the U.S.

By Delilah Alvarado • May 31, 2023

Biohaven sends latest drug to FDA, despite past trial setback

The biotech, best known for its success developing migraine medicines, will seek approval of a treatment that failed a Phase 3 trial but showed signs of a positive effect.

By Delilah Alvarado • May 31, 2023

Akebia says FDA will give its once-rejected anemia pill a second chance

The regulator denied an appeal of its decision to turn back vadadustat, but outlined a path forward for the company to resubmit an application without running another clinical trial.

By Ben Fidler • May 30, 2023

FDA approves new antibiotic for hospital-acquired pneumonia

The drug, called Xacduro, will be made available later this year by Innoviva Specialty Therapeutics, a new company formed from antibiotic developers Entasis and La Jolla.

By Delilah Alvarado • May 24, 2023

Blueprint wins key FDA approval for rare disease drug

The clearance of Ayvakit in indolent systemic mastocytosis is important to the biotech’s future. But the drug’s sales potential isn’t clear, and a top competitor is close behind.

By Ben Fidler • May 23, 2023

FDA approves Krystal gene therapy for rare wound disorder

Cleared to treat dystrophic epidermolysis bullosa, Vyjuvek is the sixth gene therapy for an inherited disease to gain clearance in the U.S.

By Delilah Alvarado • May 22, 2023

Future of Intercept’s NASH drug in doubt after FDA panel rejection

The safety risks of obeticholic acid were too great for an advisory committee to recommend approval without clear proof of its benefits. But collecting that data may not be “economically feasible,” an executive said.

By Ben Fidler • Updated May 22, 2023

FDA advisers back maternal use of Pfizer RSV vaccine

The panel voted 14-0 that Pfizer’s data showed its shot to be effective. The vaccine could be the first for protecting infants by maternal immunization.

By Christopher Newman • May 19, 2023

FDA staff unsure NASH drug’s ‘modest’ benefits outweigh safety risks

Staff scientists are concerned Intercept Pharmaceuticals’ drug — which could be the first for non-alcoholic steatohepatitis — may cause liver damage and other health problems, documents show.

By Ben Fidler • May 17, 2023

FDA panel narrowly backs approval of Sarepta’s Duchenne gene therapy

Shares in Sarepta rose by 25% Monday following a close advisory committee vote supporting accelerated approval of the biotech’s treatment, despite uncertainty around its benefit.

By Ned Pagliarulo , Ben Fidler • Updated May 12, 2023

FDA advisers back over-the-counter use of birth control pill

The committee members urged the agency to move quickly to improve access to Perrigo’s contraception pill.

By Kristin Jensen • May 11, 2023