FDA: Page 8
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Sarah Silbiger via Getty Images
FDA approves Akebia anemia pill, two years after rejection
The agency gave Akebia’s drug an OK after receiving more safety data, but imposed a strict boxed warning for its use that may limit uptake.
By Jonathan Gardner • March 28, 2024 -
Michaela Wong/BioPharma Dive
Supreme Court weighs abortion opponents’ standing in mifepristone case
The high court's treatment of the case, which centers on a conservative challenge to FDA decisions expanding abortion pill access, is seen as potentially consequential for the drug agency.
By Delilah Alvarado • March 26, 2024 -
Courtesy of Merck & Co.
FDA approves Merck lung disease drug acquired in $11B deal
Merck is couting on Winrevair, which it acquired by buying Acceleron Pharma, to help soften the blow when Keytruda loses patent protection later this decade.
By Jonathan Gardner • Updated March 27, 2024 -
Courtesy of Regeneron Pharmaceuticals
FDA rejects Regeneron lymphoma drug, setting back company’s oncology push
The agency wants Regeneron to make more progress with a confirmatory trial before clearing odronextamab, a “bispecific” antibody being developed for multiple blood cancers.
By Jonathan Gardner • March 25, 2024 -
Sarah Silbiger via Getty Images
FDA clears first-of-its-kind Duchenne drug for broad use
The approval of Italfarmaco’s Duvyzat is the first for an oral, non-steroidal Duchenne drug and was issued for all patients at least six years of age, regardless of their genetic underpinnings.
By Ben Fidler • March 22, 2024 -
Stock via Getty Images
Orchard follows buyout with FDA approval of rare disease gene therapy
The U.S. clearance of Lenmeldy, for a rare and inherited metabolic disease, triggers an additional payout related to Kyowa Kirin’s recent deal to acquire the once high-flying gene therapy developer.
By Kristin Jensen • March 19, 2024 -
Sarah Silbiger via Getty Images
FDA panel backs broader use of J&J, Bristol Myers cell therapies for myeloma
A majority of experts believed the factors that may have led to an increased risk of early death in testing of Carvykti and Abecma aren’t as likely to occur outside of a clinical trial.
By Jonathan Gardner • March 15, 2024 -
Dr_Microbe via Getty Images
Madrigal wins FDA approval of first drug for MASH
Rezdiffra’s clearance is a turning point in the fight against the liver disease. But its sales potential is unclear, and competition could emerge from popular weight loss drugs.
By Ben Fidler • March 14, 2024 -
Douglas Cliff via Getty Images
FDA clears use of Novo’s obesity drug to protect heart health
The approval makes Novo’s Wegovy the first weight-loss drug with such a claim on its prescribing information, which could have important implications for use and insurance coverage.
By Ben Fidler • March 8, 2024 -
jetcityimage via Getty Images
FDA delays decision on Lilly’s closely watched Alzheimer’s drug
The agency expects to convene a group of outside experts to more closely scrutinize the safety and efficacy of the medicine, donanemab, pushing back the timing of its potential approval.
By Jonathan Gardner • March 8, 2024 -
Courtesy of U.S. Food and Drug Administration
Minerva schizophrenia drug rejected by FDA
The agency’s complete response letter knocks back Minerva’s attempt to secure approval of the drug over agency reviewers’ objections.
By Ned Pagliarulo • Feb. 27, 2024 -
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 -
Stock via Getty Images
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 -
Justin Sullivan via Getty Images
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 -
Md Saiful Islam Khan via Getty Images
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 -
Sarah Silbiger via Getty Images
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
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