FDA: Page 2
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Johns Hopkins surgeon Makary is Trump’s pick to lead FDA
A prolific medical research and author, Martin Makary criticized the FDA and CDC for their decision-making during the pandemic, although he describes himself as pro-vaccine.
By Jonathan Gardner , Ned Pagliarulo • Nov. 22, 2024 -
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BridgeBio heart drug approved by FDA, setting up battle with Pfizer
BridgeBio shares climbed by nearly 25% Monday on news its drug for a cardiac form of transthyretin amyloidosis was approved with a broad label that looks competitive to Pfizer's tafamidis.
By Ben Fidler • Nov. 22, 2024 -
Sarah Silbiger via Getty Images
Syndax secures FDA OK for new kind of leukemia drug
Revuforj is the first so-called menin inhibitor cleared in the U.S., securing FDA approval for use in adults and certain pediatric patients with an aggressive form of acute leukemia.
By Delilah Alvarado • Nov. 18, 2024 -
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Trump names RFK Jr. as his pick to lead HHS
The president-elect’s choice of Robert F. Kennedy Jr., a vaccine skeptic who wants to disrupt U.S. health agencies, sent biotech and pharma shares sliding.
By Ned Pagliarulo • Updated Nov. 14, 2024 -
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PTC wins US approval of gene therapy for fatal enzyme disorder
Kebilidi is the first approved gene therapy that can be directly administered to the brain. Its OK secures a priority review voucher for PTC.
By Kristin Jensen • Nov. 14, 2024 -
SciePro via Getty Images
AstraZeneca, Daiichi revise approval plans for Enhertu successor
Following mixed study results, the partners have backed away from seeking broad clearance of dato-dxd in lung cancer and instead are aiming for a narrower approval.
By Ben Fidler • Nov. 12, 2024 -
Sarah Silbiger via Getty Images
FDA lifts pause on Novavax flu vaccine trials
After an investigation, the agency concluded that a case of muscle weakness in one of Novavax’s trials was actually ALS and unrelated to vaccination.
By Delilah Alvarado • Nov. 11, 2024 -
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What RFK Jr.’s influence on Trump could mean for pharma
Past comments by Robert F. Kennedy Jr. hint at the ideas he might advocate if given a role in the incoming Trump administration.
By Amy Baxter • Nov. 8, 2024 -
Chip Somodevilla via Getty Images
With Trump victorious, biotech industry’s focus turns to his plans for FDA, FTC
The president-elect has said he’ll let Robert F. Kennedy Jr. “go wild” on healthcare, while many expect a leadership change at the FTC could lower M&A scrutiny.
By Ned Pagliarulo , Ben Fidler • Nov. 7, 2024 -
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Acadia sells speedy drug review voucher for $150M
The selling price is an indication that the FDA’s planned sunsetting of the rare pediatric disease voucher program may be pushing values higher, according to one analyst.
By Kristin Jensen • Nov. 6, 2024 -
Elise Reuter/BioPharma Dive
FDA’s new device chief faces challenges. Patient groups, industry are still optimistic.
Patient advocates are hoping for change under new director Michelle Tarver, while industry groups hope she will build on former director Jeff Shuren’s leadership.
By Elise Reuter • Oct. 31, 2024 -
Elise Reuter/BioPharma Dive
FDA names Tarver as new head of device center
Michelle Tarver will officially replace longtime CDRH leader Jeff Shuren, who stepped down from the role earlier this year.
By Elise Reuter • Oct. 22, 2024 -
SciePro via Getty Images
Novocure wins FDA approval for electric field device in lung cancer
Alongside immunotherapy or chemo, the wearable device helped patients live longer in a trial, though the results are somewhat controversial.
By Jonathan Gardner • Oct. 16, 2024 -
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 -
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
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