FDA: Page 10
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Permission granted by Peyton Helbert / AAMI
Lawmakers call for investigation of former FDA device director
The letter follows a New York Times report that raised concerns about Jeff Shuren’s potential conflicts of interest as head of the FDA’s device center.
By Elise Reuter • Sept. 26, 2024 -
Courtesy of Apellis Pharmaceuticals
Apellis eye drug again turned back in Europe
The decision against Syfovre’s approval follows efforts by Apellis to have reviewers reevaluate clinical evidence multiple times and, according to an analyst, will lead to a restructuring of the company’s operations in Europe.
By Ben Fidler • Sept. 20, 2024 -
Sarah Silbiger via Getty Images
FDA advisory panels in the spotlight, as reform talks heat up
Following a recent listening session hosted by the agency, current and former members have weighed in on the process and how it could be improved.
By Amy Baxter • Sept. 3, 2024 -
Permission granted by Peyton Helbert / AAMI
FDA defends med device chief’s tenure after report raises ethics concerns
The FDA backed Jeff Shuren, the agency’s former CDRH leader, amid questions raised by The New York Times. Still, a spokesperson said the FDA has advised Shuren to take greater caution in managing recusal obligations.
By Susan Kelly • Aug. 22, 2024 -
Mario Tama via Getty Images
J&J drug combo for lung cancer approved by FDA
Approval of Rybrevant and Lazcluze was supported by results from a study that compared the regimen to AstraZeneca’s widely used drug Tagrisso.
By Ned Pagliarulo • Aug. 20, 2024 -
Courtesy of Gilead
FDA clears Gilead drug acquired in $4.3B buyout
Livdelzi, which Gilead inherited through its acquisition of CymaBay, will now compete with medicines for primary biliary cholangitis that are currently marketed by Ipsen and Alfasigma.
By Kristin Jensen • Aug. 15, 2024 -
Sarah Silbiger via Getty Images
FDA approves Ascendis drug for rare endocrine condition
The clearance of Yorvipath for hypoparathyroidism was some time coming for Ascendis, which had resubmitted after receiving a rejection last year.
By Ned Pagliarulo • Aug. 12, 2024 -
Sarah Silbiger via Getty Images
In tone-setting verdict, FDA rejects MDMA as a therapy aid for PTSD
The decision to turn down an application from Lykos Therapeutics came at a pivotal time for psychedelics research, which, after decades of dismissal, has recently gained momentum.
By Jacob Bell • Updated Aug. 9, 2024 -
Kent Nishimura via Getty Images
Warren, Democratic lawmakers introduce bill to resurrect Chevron doctrine
The Stop Corporate Capture Act would codify the Chevron doctrine, which required federal courts to give deference to agencies’ reasonable interpretation of ambiguous statutes.
By Ginger Christ • July 25, 2024 -
Permission granted by Peyton Helbert / AAMI
FDA medical device chief Shuren to step down after 15 years
Michelle Tarver, deputy director for transformation, will serve as acting director of the FDA’s medical devices office.
By Susan Kelly , Elise Reuter • July 24, 2024 -
Anna Moneymaker / Staff via Getty Images
FDA’s lab-developed test rule could be first test of agency’s power post-Chevron
The Supreme Court’s decision to overturn the Chevron doctrine would make it easier to challenge agency regulations, such as the LDT final rule.
By Susan Kelly , Elise Reuter • July 11, 2024 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
5 FDA decisions to watch in the third quarter
Multibillion-dollar buyouts from Bristol Myers Squibb and Gilead could yield new drugs for brain and liver diseases, while a new cell therapy may reach market.
By BioPharma Dive staff • July 3, 2024 -
Scott Olson via Getty Images
New Alzheimer's drugsLilly drug for Alzheimer’s approved by FDA
The drug, which Lilly will sell as Kinsunla, carries a warning for the risk of a certain kind of imaging abnormality that can be serious in rare cases.
By Jonathan Gardner • Updated July 2, 2024 -
Sarah Silbiger via Getty Images
Rocket gene therapy rejected by FDA over manufacturing
The complete response letter follows other recent manufacturing-related rejections, including one for a cell therapy from Abeona Therapeutics.
By Ned Pagliarulo • June 28, 2024 -
Andrew Harnik via Getty Images
Supreme Court overturns Chevron doctrine, limiting reach of federal agencies
Federal courts will no longer have to defer to agency regulations for interpretation of ambiguous statutes, a ruling that could have significant impact on the FDA and CMS.
By Ryan Golden , Ginger Christ • June 28, 2024 -
Ermath, Michael. (2020). "Individualized Therapies Workshop" [Photograph]. Retrieved from Flickr.
Duchenne approval exposes FDA rift over Sarepta gene therapy
Peter Marks’ decision to override the objections of agency staff and broaden use of Elevidys could have a “lasting impact” on gene therapy as well as the FDA, one analyst wrote at the time.
By Ben Fidler • June 21, 2024 -
Courtesy of Sarepta
Sarepta Duchenne gene therapy wins broader use from FDA
The approval makes Elevidys available to most Duchenne patients at least 4 years of age, despite mixed trial results that have led to skepticism about its effectiveness.
By Ben Fidler • Updated June 21, 2024 -
Kena Betancur via Getty Images
Merck wins FDA OK for vaccine rival to Pfizer’s pneumococcal shot
The new vaccine, which Merck will sell as Capvaxive, will compete with Pfizer’s blockbuster Prevnar franchise.
By Delilah Alvarado • June 18, 2024 -
Anna Moneymaker via Getty Images
Abortion pill ruling offers measure of relief for FDA, biotech
A biotech executive called the Supreme Court’s decision a “very important win” for the industry, although new challenges to the FDA’s regulation of the drug could still be forthcoming.
By Delilah Alvarado • June 17, 2024 -
Anna Moneymaker via Getty Images
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 -
Getty Images
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 -
Scott Olson via Getty Images
New Alzheimer's drugs
Lilly 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 -
Getty Images
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 -
Getty Images
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
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