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Home » Topics » Regulatory

Regulatory
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Marks’ departure intensifies regulatory uncertainty at US FDA

March 31, 2025
By Mari Serebrov
Peter Marks’ March 28 letter giving one week’s notice of his resignation as director of the U.S. FDA’s Center for Biologics Evaluation and Research (CBER) is sending more ripples of uncertainty throughout the industry. Marks, who has helmed CBER for nearly a decade, blamed his departure on recently confirmed Health and Human Services (HHS) Secretary Robert Kennedy, who has made a career out of his anti-vaccine stance.
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3d illustration of ovarian cancer

Corcept looks to NDA following strong phase III ovarian cancer data

March 31, 2025
By Lee Landenberger
Relacorilant, a cortisol modulator from Corcept Therapeutics Inc., produced new and strong phase III results in treating platinum-resistant ovarian cancer. The company also has relacorilant in studies that could eventually lead to approval in other indications. In the near term, though, the positive data led to the company’s stock (NASDAQ:CORT) closing 109% higher at $114.22 per share on March 31.
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3D illustration of tumor
Immuno-oncology

Sun Pharma Advanced Research files IND for SBO-154 for advanced solid tumors

March 31, 2025
Sun Pharma Advanced Research Co. Ltd. has filed an IND application with the FDA for SBO-154 for the treatment of solid tumors. A global phase I study is planned in advanced solid tumors.
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Environmental Protection Agency - US EPA

EPA to reconsider air standards for ethylene oxide

March 28, 2025
By Mark McCarty
In a move that undoubtedly has the unspoken support of the medical device industry, the U.S. Environmental Protection Agency (EPA) reported it will revisit several rules governing emissions that affect a broad swath of industries.
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Australia flag with microscope, test tubes

Australia looks to Asia as Trump administration threatens funding

March 28, 2025
By Tamra Sami
Australia’s top universities are looking more to Asia for research collaborations following threats from the Trump administration to stop funding research at institutions that don’t comply with U.S. narratives.
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Illustration of hole in vessel wall with repair process in progress

Sanofi adds to hemophilia arsenal with FDA nod for Qfitlia

March 28, 2025
By Jennifer Boggs
Sanofi SA gained U.S. FDA approval for fitusiran as a first-in-class siRNA therapy for hemophilia. Branded Qfitlia, the antithrombin-lowering therapy is indicated for use as a prophylactic treatment to prevent or reduce bleeding episodes in people with hemophilia A or B, with or without inhibitors, and joins the small but growing group of non-factor therapy options, with the advantage of a broad label and a convenient dosing regimen.
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Myst it again: Milestone gets a CRL for its heart spray

March 28, 2025
By Lee Landenberger
Milestone Pharmaceuticals Inc.’s heart rhythm-restoring calcium channel blocker for paroxysmal supraventricular tachycardia (PSVT) has yet another obstacle in its way. 
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Alzheimer’s drug Kisunla rejected by European regulators

March 28, 2025
By Nuala Moran
The EMA has rejected the Alzheimer’s disease therapy Kisunla (donanemab) from Eli Lilly and Co., saying the benefits of the anti-amyloid antibody do not outweigh the risks of edema and hemorrhage in the brain, known as amyloid-related imaging abnormalities (ARIA).
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Vykat XR

First Prader-Willi treatment Vykat XR FDA-approved: Soleno soars

March 27, 2025
By Karen Carey
Becoming the first treatment for rare genetic disorder Prader-Willi syndrome, breakthrough therapy drug DCCR (diazoxide choline) gained U.S. FDA approval as Vykat XR the evening before its March 27 PDUFA date, sending shares of developer Soleno Therapeutics Inc. up 38%.
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Abbott Labs Volt

Abbott’s Volt enters the PFA fray with CE mark

March 27, 2025
By Annette Boyle
Abbott Laboratories snagged a CE mark for its Volt pulsed field ablation catheter for atrial fibrillation several months earlier than the mid-year approval expected. The Abbott Park, Ill.-based company has begun Volt’s commercial launch with the physicians who participated in its European clinical trials and plans to expand to other users on the continent in the second half of 2025.
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