FDA staff hold ‘major concerns’ with Brainstorm ALS therapy, documents show

A panel of expert FDA advisers is meeting today to discuss the treatment, and whether Brainstorm’s data provide “substantial evidence” of its effectiveness.

By Ned Pagliarulo • Sept. 25, 2023

Intarcia’s diabetes drug-device combo voted down again by FDA panel

The 19-member advisory committee unanimously voted against Intarcia in the review, citing cardiovascular and kidney safety concerns.

By Gwendolyn Wu • Sept. 21, 2023

Alvotech gets new FDA review for Humira biosimilar

The regulator has twice rejected Alvotech’s copycat drug due to manufacturing issues with a plant in Europe.

By Jonathan Gardner • Sept. 20, 2023

Orchard nears FDA decision on rare disease gene therapy

Three years after gaining European approval, Libmeldy is now under U.S. review with a deadline set for March.

By Jonathan Gardner • Sept. 18, 2023

FDA approves updated COVID boosters from Pfizer, Moderna

Pfizer and Moderna, which have seen slowing demand for their coronavirus vaccines, expect their reformulated shots will soon be available in the U.S.

By Delilah Alvarado • Sept. 11, 2023

FDA documents hint at ‘uphill battle’ for broad approval of Sage’s depression drug

The newly posted documents show the agency had concerns about the side effects experienced by people with clinical depression who took Sage’s drug, Zurzuvae.

By Jacob Bell • Sept. 1, 2023

Bristol Myers gets key FDA approval for bone marrow disease drug

A broadened clearance for Reblozyl in myelodysplastic syndromes should help Bristol Myers offset the looming loss of revenue from top-selling medicines set to soon lose market exclusivity.

By Ben Fidler • Aug. 29, 2023

FDA approves Novartis’ copycat of blockbuster Biogen drug

According to one analyst, the approval was the last hurdle keeping Sandoz’s Tyruko from directly competing in the U.S. market against Biogen’s inflammation-regulating medicine Tysabri.

By Jacob Bell • Updated Aug. 25, 2023

FDA approves Pfizer’s RSV vaccine for use in pregnancy

The shot, called Abrysvo, is the first maternal immunization approved to protect newborns from the respiratory virus in their first months of life.

By Delilah Alvarado • Aug. 21, 2023

FDA partially halts leukemia studies of Gilead cancer drug

The hold is the latest setback for a drug that was the center of Gilead’s $5 billion acquisition of biotech Forty Seven in 2020.

By Jonathan Gardner • Aug. 21, 2023

Regeneron rebounds to win FDA OK for longer-lasting vision loss drug

The agency cleared high-dose Eylea less than two months after rejecting it, and approved a separate Regeneron drug for an ultra-rare disease as well.

By Ben Fidler • Aug. 21, 2023

FDA clears Ipsen bone drug despite questions about its benefits

The mixed results supporting the treatment, Sohonos, have proven a tough case for regulators and led to different outcomes in the U.S. and Europe.

By Kristin Jensen • Aug. 17, 2023

Appeals court rules to limit abortion pill access

Federal judges said recent changes by the FDA to loosen prescribing rules for mifepristone should be rolled back. Biotech leaders have warned the case could undermine the agency’s authority.

By Delilah Alvarado • Updated Aug. 17, 2023

FDA lifts hold on Arcellx’s Gilead-partnered cancer cell therapy

The agency had paused testing after a patient death, but is now permitting more types of bridging treatment to help keep participants’ disease at bay.

By Jonathan Gardner • Aug. 15, 2023

FDA approves bispecific drug from Pfizer for multiple myeloma

Elrexfio is the third bispecific antibody cleared to treat the cancer, and will compete with other therapies that target the “BCMA” protein on myeloma cells.

By Jonathan Gardner • Aug. 14, 2023

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