FDA: Page 9
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Supreme Court preserves access to abortion pill in unanimous ruling
The high court said the plaintiffs’ “desire to make a drug less available to others” did not give them standing to challenge the FDA's expansion of mifepristone’s approval.
By Delilah Alvarado • June 13, 2024 -
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Ipsen drug for rare liver disease approved by FDA
The medicine will join Intercept’s Ocaliva as a treatment option for primary biliary cholangitis. Another drug, from the now Gilead-owned CymaBay, could be cleared for the condition by August.
By Ned Pagliarulo • June 11, 2024 -
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New Alzheimer's drugsLilly Alzheimer’s drug gets unanimous backing of FDA panel
The expert committee's twin 11-0 votes tees up donanemab for U.S. approval later this year and a market showdown with Leqembi.
By Jacob Bell , Jonathan Gardner • Updated June 11, 2024 -
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After ‘sobering’ FDA panel, psychedelics supporters wonder what’s next
A vote against MDMA-assisted therapy set back a high-profile treatment. Proponents argue the panel offered few solutions to longstanding problems, making the path forward unclear.
By Jacob Bell • June 7, 2024 -
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In review of Lilly Alzheimer’s drug, FDA staff focus on safety, patient selection
An advisory panel is meeting today to discuss whether donanemab is effective across different groups of Alzheimer's patients, and to give input on an unusual dosing strategy used by Lilly.
By Jonathan Gardner • June 6, 2024 -
Sarah Silbiger via Getty Images
FDA advisers back updating COVID shots to target JN.1 virus family
The unanimous recommendation from the panel should help Novavax, which would have had difficulty adapting its shot in time if the committee picked a more specific subvariant.
By Delilah Alvarado • June 6, 2024 -
Sarah Silbiger via Getty Images
FDA panel votes against MDMA therapy for PTSD, citing muddy data and safety concerns
“I just feel very convinced that I had to vote no,” said one member of the committee, which was unconvinced by Lykos Therapeutics’ data on MDMA-assisted treatment for post-traumatic stress disorder.
By Jacob Bell • Updated June 4, 2024 -
Sarah Silbiger via Getty Images
FDA staff outline shortcomings of Lykos data for MDMA therapy
A panel of expert advisers met Tuesday to discuss several sticking points in the clinical trial results backing Lykos’ treatment for PTSD.
By Jacob Bell • May 31, 2024 -
Permission granted by Moderna
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 -
Ermath, Michael. (2020). "Individualized Therapies Workshop" [Photograph]. Retrieved from Flickr.
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 -
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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 -
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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 -
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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 -
Sarah Silbiger via Getty Images
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 -
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 -
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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 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
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 -
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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 -
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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
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