FDA: Page 3
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Obesity drugsLilly rival to weight loss drug Wegovy approved by FDA
The pharmaceutical company will sell the GLP-1 drug, branded as Zepbound, at a list price about 20% lower than Novo Nordisk's competing therapy.
By Jonathan Gardner , Ned Pagliarulo • Updated Nov. 8, 2023 -
Sarah Silbiger via Getty Images
Vertex, CRISPR therapy for sickle cell passes FDA panel test
The high-profile meeting focused on the theoretical risks of CRISPR gene editing, as both the FDA and its advisory committee appeared convinced by the efficacy of the companies’ exa-cel treatment.
By Ned Pagliarulo • Oct. 31, 2023 -
A play-by-play of the FDA’s meeting on Vertex, CRISPR’s sickle cell therapy
Expert advisers dug deep on the risks of off-target gene editing and debated how best to set guidelines for the fast-growing field. Catch up on their full discussion here.
By Ned Pagliarulo , Jonathan Gardner , Gwendolyn Wu • Updated Oct. 31, 2023 -
Sarah Silbiger/Getty Images via Getty Images
FDA staff focus on ‘off-target’ risk in review of Vertex, CRISPR sickle cell therapy
Documents released ahead of a Tuesday advisory meeting show agency scientists to be generally convinced by the treatment’s benefit, a sign analysts read as positive.
By Ned Pagliarulo • Oct. 27, 2023 -
Permission granted by AstraZeneca
Supply shortage hits infant RSV antibody Beyfortus
The CDC is asking doctors to ration supply of Sanofi and AstraZeneca’s new RSV drug Beyfortus, as demand has outstripped supply.
By Delilah Alvarado • Oct. 25, 2023 -
Permission granted by Novartis
Novartis delays FDA filing for in-demand radiopharma drug
Mixed survival data from a study of Pluvicto in earlier prostate cancer sparked the slower regulatory timeline.
By Jonathan Gardner • Oct. 24, 2023 -
Jeenah Moon via Getty Images
Pfizer wins FDA approval of new meningococcal vaccine
The clearance of the pentavalent shot Penbraya adds to Pfizer’s infectious disease portfolio as it adjusts to slumping COVID-19 vaccine sales.
By Delilah Alvarado • Oct. 23, 2023 -
Sarah Silbiger via Getty Images
ALS drug developmentBrainStorm, after setbacks, withdraws approval application for ALS drug
A panel of FDA advisers last month found BrainStorm’s data unconvincing. The company now says a Phase 3b study will be needed for its NurOwn cell therapy to have a shot at an approval.
By Jacob Bell • Oct. 18, 2023 -
Courtesy of Merck & Co.
Keytruda gains first approval for pre- and post-surgery use in lung cancer
The Merck drug leads competitors Opdivo and Imfinzi into a new immunotherapy setting, which aims to improve outcomes following the surgical removal of tumors.
By Jonathan Gardner • Oct. 17, 2023 -
Erik Karits via Getty Images
Research group says FDA found no misconduct in Pfizer Lyme vaccine trial it helped run
Earlier this year Pfizer removed thousands of participants from a study of its Lyme disease shot over concerns the group, Care Access, wasn't meeting clinical practice standards.
By Delilah Alvarado • Oct. 12, 2023 -
Sarah Silbiger via Getty Images
PepGen cleared by FDA to begin study of muscular dystrophy drug
The company expects to deliver first results next year from the early-stage study of people with myotonic dystrophy type 1.
By Kristin Jensen • Oct. 12, 2023 -
Alnylam Pharmaceuticals
FDA denies expanded approval for Alnylam RNA drug
The agency rejected Alnylam’s application for approval of its medicine patisiran in people with a rare heart condition, setting back the company’s plans.
By Jonathan Gardner • Updated Oct. 9, 2023 -
Sarah Silbiger via Getty Images
FDA panel finds KRAS drug data unreliable, in blow to Amgen
The negative panel vote likely means Amgen will need more data to support a full approval for its conditionally cleared lung cancer drug Lumakras.
By Ned Pagliarulo • Updated Oct. 6, 2023 -
Sarah Silbiger via Getty Images
5 FDA decisions to watch in the fourth quarter
The regulator’s decision on Alnylam’s bid to expand Onpattro’s approval didn’t go the company’s way, but other verdicts await on drugs from Vertex, Bristol Myers, Amgen and Pfizer.
By Ned Pagliarulo , Jonathan Gardner • Oct. 2, 2023 -
Sarah Silbiger via Getty Images
ALS drug developmentBrainStorm’s ALS therapy not effective, FDA panel finds
Expert advisers to the agency voted 17-1 that Brainstorm's clinical trial data did not show the company's stem cell treatment to be effective for treating ALS.
By Ned Pagliarulo • Updated Sept. 28, 2023 -
Courtesy of U.S. Food and Drug Administration
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 -
Sarah Silbiger via Getty Images
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 -
Courtesy of U.S. Food and Drug Administration
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 -
Jonathan Gardner / BioPharma Dive
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 -
Sarah Silbiger via Getty Images
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 -
Jacob Bell / BioPharma Dive
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 -
Courtesy of Bristol Myers Squibb
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 -
Novartis
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 -
Sarah Silbiger via Getty Images
RSV vaccines
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 -
Justin Sullivan via Getty Images
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
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