FDA
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Courtesy of Roche
Roche wins FDA OK for Alecensa in early lung cancer
Alecensa is the first targeted drug available after surgery for people with ALK-positive lung tumors, who are at high risk for brain metastases.
By Ben Fidler • April 19, 2024 -
Courtesy of Vertex Pharmaceuticals
Vertex begins bid for US approval of non-opioid painkiller
The biotech has begun a rolling submission of a closely watched drug that’s important to its future, but faces questions of sales potential.
By Ben Fidler • April 18, 2024 -
Peddalanka Ramesh Babu via Getty Images
FDA approves CAR-T therapies from J&J, Bristol Myers for earlier myeloma use
The FDA quickly followed last week’s clearance of Bristol Myers’ Abecma with an OK for J&J’s Carvykti, but gave the rival treatments different labels.
By Ned Pagliarulo • Updated April 8, 2024 -
Dr_Microbe via Getty Images
FDA approves new antibiotic for several hard-to-treat infections
Swiss pharma Basilea has won clearance for Zevtera after a long development journey, but is still searching for a commercial partner in the U.S.
By Kristin Jensen • April 4, 2024 -
5 FDA decisions to watch in the second quarter
The FDA could soon expand use of two multiple myeloma cell therapies as well as a top-selling medicine from Sanofi and Regeneron, while Pfizer’s years of gene therapy work might finally pay dividends.
By BioPharma Dive staff • April 1, 2024 -
Christopher Furlong via Getty Images
AstraZeneca gets FDA OK for rare disease drug acquired in Alexion buyout
The approval of Voydeya as an add-on therapy for an uncommon blood disease validates a bet Alexion made on original developer Achillion five years ago.
By Ben Fidler • April 1, 2024 -
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 -
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 -
libre de droit 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
