FDA: Page 12
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Sara Silbiger via Getty Images
Humira biosimilar from Alvotech, Teva wins FDA approval on third attempt
The companies didn’t reveal their planned price for Simlandi, which will be the 10th Humira copycat to reach the U.S. market.
By Jonathan Gardner • Feb. 26, 2024 -
Sarah Silbiger via Getty Images
United Therapeutics, in unusual step, sues FDA over rival’s drug application
The biotech alleges the agency is letting rival Liquidia sidestep the rules by accepting an amendment to an application that’s involved in a patent dispute.
By Kristin Jensen • Feb. 21, 2024 -
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FDA puts hold on Rapt trials of drug for eczema, asthma
Rapt reported one case of liver failure in a study participant who received the biotech’s drug, which is seen by analysts as a possible competitor to Dupixent.
By Delilah Alvarado • Feb. 20, 2024 -
Courtesy of Iovance Biotherapeutics
Iovance, with approval of ‘TIL’ cell therapy, readies for complex launch
The biotech set a price of roughly $515,000 per patient for its therapy Amtagvi, the first to be approved based on a decades-old technique of using tumor-infiltrating lymphocytes.
By Ben Fidler • Feb. 20, 2024 -
Courtesy of Sarepta
FDA to review expanded use of Sarepta Duchenne gene therapy
The agency will decide by June 21 whether to broaden eligibility for Elevidys, and won’t convene a group of outside experts beforehand.
By Jonathan Gardner • Feb. 16, 2024 -
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Gilead reviewing drug acquired in $5B buyout after latest setback
The FDA paused enrollment in the only remaining tests of the drug, as Gilead reviews the program it acquired through a buyout of biotech Forty Seven.
By Ben Fidler • Feb. 16, 2024 -
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AstraZeneca, Daiichi aim for first pan-tumor ADC approval
The FDA is reviewing the companies’ application for a “tumor agnostic” indication for their drug Enhertu, which would break new ground for antibody-drug conjugates.
By Ben Fidler • Jan. 29, 2024 -
Courtesy of Bristol Myers Squibb
EMA recommends earlier use of Bristol Myers cell therapy for multiple myeloma
The opinion would allow Abecma to be prescribed after two standard therapies and is the latest sign of CAR-T’s growing use in earlier cancer treatment.
By Jonathan Gardner • Jan. 26, 2024 -
Carl Court via Getty Images
PTC Duchenne drug approval set to be revoked in Europe
The EMA’s drugs committee again recommended rescinding an OK for Translarna, which was cleared in 2014 despite questions about its benefit.
By Ben Fidler • Jan. 26, 2024 -
Sarah Silbiger via Getty Images
At FDA meeting, experts wrestle with hurdles to developing preterm birth drugs
A workshop highlighted the lack of investment and inadequate understanding of what causes early births, making drug research more challenging.
By Delilah Alvarado • Jan. 25, 2024 -
FDA orders new cancer warnings for CAR-T therapies
The agency later modified its warning for Gilead's Tecartus, tweaking the label's language to reflect the fact that none of T cell malignancies in question had occurred in Tecartus-treated patients.
By Jonathan Gardner • Updated Jan. 24, 2024 -
Mario Tama / Getty via Getty Images
FDA says no ‘clear relationship’ between GLP-1 drugs and suicide risk
Regulators will continue to evaluate suicide ideation as the data don't "definitively rule out" an association.
By Jonathan Gardner • Jan. 12, 2024 -
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FDA authorizes Florida to import drugs from Canada
The clearance is a major shift for the agency, which described its decision as a “first step” in allowing Florida to bulk purchase lower-cost Canadian medicines.
By Jonathan Gardner , Ned Pagliarulo • Jan. 5, 2024 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
5 FDA decisions to watch in the first quarter
The agency could soon issue verdicts on new drugs from Eli Lilly and Merck, as well as on what could be the first TIL therapy.
By Ben Fidler , Ned Pagliarulo • Jan. 4, 2024 -
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 -
Courtesy of Eli Lilly
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
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