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

FDA staff skeptical of Sarepta’s Duchenne gene therapy, documents show

Sarepta has not provided “unambiguous evidence” its treatment can help patients, agency scientists wrote in documents released ahead of a crucial Friday advisory committee meeting.

By Ben Fidler • Updated May 10, 2023

Abortion providers in 3 states sue over mifepristone restrictions

The lawsuit seeks to remove safety restrictions on mifepristone or, alternatively, prevent further altering of access to the drug.

By Sydney Halleman • May 9, 2023

‘The luckiest of the unlucky’: A Duchenne gene therapy brings hope to families — and tests the FDA

FDA advisers voted 8-6 in support of the agency approving a treatment that patient advocates and doctors believe to be a breakthrough for a deadly disease.

By Ben Fidler , Shaun Lucas • May 7, 2023

FDA approves first RSV vaccine, clearing GSK’s Arexvy for older adults

The decision represents the first fruits of a scientific breakthrough a decade ago that gave drugmakers, among them GSK, Pfizer and Moderna, a blueprint for an effective shot against the virus.

By Delilah Alvarado • Updated May 3, 2023

FDA clears Pfizer’s pneumococcal vaccine for infants and children

Pfizer’s latest Prevnar shot covers 20 strains of the virus, more than the 13 covered by its previous version and the 15 by Merck’s Vaxneuvance.

By Delilah Alvarado • Updated May 3, 2023

FDA approves Seres’ microbiota drug for recurrent gut infection

The drug is the first microbiota-based pill to win U.S. approval. Like a rival therapy approved in December, it’s for difficult-to-treat C. diff. infections.

By Christopher Newman • Updated April 27, 2023

Supreme Court maintains access to abortion pill, blocking restrictions on its use

The stay suspends a Texas judge’s order that invalidated the FDA’s approval of mifepristone, keeping it available while a circuit court hears the case.

By Delilah Alvarado • Updated April 22, 2023

FDA approves earlier use of Roche’s Polivy in common form of lymphoma

The agency’s decision also converts the biologic drug's approval from accelerated to full, confirming an earlier OK based on tumor responses.

By Jonathan Gardner • April 20, 2023

Supreme Court delays decision in battle over abortion pill

An administrative stay of a Texas district court ruling will remain in place through Friday, pushing out a Supreme Court decision in the closely watched case over the drug mifepristone.

By Delilah Alvarado • April 19, 2023

FDA favors single dose of updated COVID shots in shift to simplify vaccination

The regulator also authorized a second bivalent booster for adults 65 years or older, or those with weak immune systems.

By Delilah Alvarado • April 18, 2023