FDA: Page 8
-
Carsten Koall via Getty Images
FDA puts Novavax flu vaccine trials on hold
The hold, which was made in response to a serious adverse event report, could impact the company’s plans to start a Phase 3 trial of a combination shot for COVID-19 and influenza.
By Delilah Alvarado • Oct. 16, 2024 -
Sarah Silbiger via Getty Images
FDA, facing pressure, to review position on Zepbound, Mounjaro shortage
The agency agreed in court to allow compounding companies to continue producing copycat versions of Lilly’s fast-selling medicines while it reevaluates its recent decision to declare the drugs back in supply.
By Jonathan Gardner • Oct. 14, 2024 -
Jacob Bell/BioPharma Dive
Pfizer drug for hemophilia approved by FDA
The approval of Hympavzi Friday was a dose of good news for Pfizer, which is dealing with research setbacks and a challenge from an activist investor.
By Ned Pagliarulo • Oct. 14, 2024 -
Daniel Karmann/Picture-Alliance/DPA/AP
The number of AI medical devices has spiked in the past decade
The FDA has authorized nearly 1,000 medical devices with artificial intelligence features as companies including GE Healthcare and Siemens Healthineers build out their AI efforts.
By Elise Reuter , Jasmine Ye Han • Oct. 10, 2024 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
5 FDA decisions to watch in the fourth quarter
Over the next three months, the agency could approve a rival to a fast-selling Pfizer heart drug, a much-debated lung cancer medicine and an addition to Vertex's dominant cystic fibrosis business.
By BioPharma Dive staff • Oct. 1, 2024 -
Permission granted by Sanofi
FDA, after delay, clears Regeneron and Sanofi drug for COPD
Dupixent is the first biologic medicine approved in the U.S. for the lung condition, though competitors from GSK, AstraZeneca and Roche could follow.
By Ben Fidler • Sept. 27, 2024 -
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
Previous
