FDA
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FDA staff outline shortcomings of Lykos data for MDMA therapy
Ahead of an advisory panel meeting, agency staff identified several sticking points in the clinical results backing Lykos’ ecstasy-based treatment for PTSD.
By Jacob Bell • May 31, 2024 -
RSV vaccines
Moderna wins FDA approval for RSV vaccine
The OK for mResvia adds another option for preventing RSV-related disease in older adults, one year after the agency cleared shots from GSK and Pfizer.
By Delilah Alvarado • May 31, 2024 -
With Duchenne decision ahead, FDA’s Marks pushes for speedy gene therapy approvals
But the head of the FDA’s CBER office didn’t tip where the agency stands on potentially broadening use of Sarepta’s Duchenne gene therapy Elevidys.
By Ben Fidler • May 24, 2024 -
FDA approves Amgen drug for tough-to-treat form of lung cancer
Imdelltra, a bispecific antibody targeting a protein called DLL3, is cleared for use following chemotherapy in treating extensive-stage small cell lung cancer.
By Jonathan Gardner • May 17, 2024 -
RSV vaccines
FDA delays decision on Moderna RSV vaccine
The regulator cited “administrative constraints,” rather than any issue with Moderna’s trial data, for missing a May 12 deadline, the company said.
By Delilah Alvarado • May 10, 2024 -
Pfizer hemophilia gene therapy arrives in US to uncertain future
The Food and Drug Administration approval of Beqvez comes as other gene therapies for the bleeding condition struggle to gain traction.
By Ben Fidler • April 26, 2024 -
FDA rejects Abeona cell therapy, asks for more manufacturing data
The complete response letter for Abeona’s treatment is one of several manufacturing setbacks for cell and gene therapy developers in recent years.
By Ben Fidler • April 23, 2024 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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