FDA: Page 9
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FDA
FDA ends busy year with three drug rejections
Amgen had its bid for full approval of the cancer drug Lumakras turned back by the agency, which also issued complete response letters to Zealand Pharma and Merck & Co. in December.
By Jonathan Gardner • Jan. 2, 2024 -
Courtesy of Sarepta
Sarepta tests FDA flexibility with bid to expand Duchenne gene therapy’s approval
The biotech is asking the agency to clear its treatment Elevidys in more patients with the disease, despite a confirmatory trial that missed its main goal.
By Ned Pagliarulo • Dec. 22, 2023 -
Sara Silbiger via Getty Images
Ionis, Astrazeneca win FDA approval of competitor to Alnylam drug
The clearance of Wainua for transthyretin amyloidosis opens up a new front in a long-running commercial battle between Ionis and Alnylam.
By Ben Fidler • Dec. 22, 2023 -
Courtesy of Merck & Co.
Merck gets FDA decision date for new pneumococcal vaccine
The company’s shot targets 21 strains of pneumococcal bacteria and, if approved, would compete with Pfizer’s Prevnar 20.
By Delilah Alvarado • Dec. 19, 2023 -
FDA
FDA widens use of cancer drug Merck acquired for $1B
Welireg, which Merck got through its purchase of Peloton Therapeutics, can now be used to treat an advanced form of kidney cancer, adding to an earlier clearance in a rare genetic disease.
By Jonathan Gardner • Dec. 15, 2023 -
Carl Court via Getty Images
European regulators push Biogen, CRISPR drugs toward approval
While a positive recommendation for the gene editing treatment Casgevy was expected, a clearance for Biogen’s Skyclarys has been no sure bet.
By Ben Fidler • Dec. 15, 2023 -
Permission granted by Novartis
Novartis gets FDA approval of closely watched rare disease drug
The pharma is developing Fabhalta, now cleared for paroxysmal nocturnal hemoglobinuria, for several other rare, complement-driven diseases.
By Ned Pagliarulo • Dec. 6, 2023 -
Lilly cancer drug cleared by FDA for expanded leukemia, lymphoma use
Jaypirca, which has been on the market for less than a year, can now be used for more types of blood cancer but not as early as rival drugs from AbbVie and AstraZeneca.
By Jonathan Gardner • Dec. 4, 2023 -
shutterstock.com/DadBusiness
Sponsored by Target RWEOvercoming scalability challenges in real-world data processing for transformative patient care
Accurate and timely processing of data is imperative to create robust analytical datasets that can be used in the RWE setting.
By Rob Sullivan, Chief Data & Analytics Officer • Dec. 4, 2023 -
FDA names chief scientist Bumpus as Woodcock’s successor
Bumpus, a former Johns Hopkins professor, named “creating a new model” for the FDA’s Office of Regulatory Affairs as one of her priorities when she steps into the role next year.
By Jonathan Gardner • Nov. 29, 2023 -
Peddalanka Ramesh Babu via Getty Images
FDA investigating cancer risk linked to CAR-T cell therapy
Reports of T cell malignancies following treatment triggered the FDA’s alert. But the event appears rare, according to companies and physicians.
By Jonathan Gardner • Updated Nov. 28, 2023 -
Win McNamee via Getty Images
Top FDA official Woodcock to retire early next year
The 37-year veteran helmed the agency’s pandemic response, and was a key decision-maker in controversial calls on opioids, an Alzheimer's therapy and muscular dystrophy drugs.
By Jonathan Gardner • Updated Nov. 17, 2023 -
SciePro via Getty Images
FDA approves new Bristol Myers drug for lung cancer
Acquired via a $4 billion biotech buyout, Augtyro is one of an array of new products the pharma hopes will offset patent expirations for current top sellers.
By Jonathan Gardner • Nov. 16, 2023 -
Valneva’s chikungunya vaccine approved by FDA
The preventive shot is the first to receive regulatory approval for the mosquito-borne illness, which is growing in prevalence worldwide.
By Delilah Alvarado • Nov. 10, 2023 -
Takeda secures FDA approval for colon cancer drug
The pharma paid $400 million to license the drug from Hutchmed earlier this year in an effort to bolster its oncology business.
By Delilah Alvarado • Nov. 9, 2023 -
Sarah Silbiger via Getty Images
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 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
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
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