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Home » Topics » Regulatory » FDA

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Laptop displaying FDA logo

FDA’s device center playing guidance catch-up

June 5, 2025
By Mark McCarty
The U.S. FDA’s Center for Devices and Radiological Health is recovering from a guidance drought that spanned several months in the first part of calendar year 2025, starting with a guidance on the Q-sub process.
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Regulatory, financial hurdles the gap between science and access

June 5, 2025
By Mari Serebrov
No Comments
Children with solid tumors who relapse are being treated with the same chemotherapy they would have been given 40 years ago, as “there have been no major approvals for pediatric solid tumors,” Catherine Bollard, senior vice president and chief research officer at Children’s National Hospital, said at a June 5 FDA roundtable on cell and gene therapies (CGTs). The problem isn’t the science. Bollard said many groups are working on curative CGTs “for these children who have lost all other hope for survival.” The real gap is that “big pharma doesn’t see the business model because it’s a rare disease,” she added.
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Mesothelioma
Immuno-oncology

Oncovita’s Mvdeltac designated orphan drug for pleural mesothelioma

June 5, 2025
No Comments
Oncovita SAS’s lead oncolytic virus candidate, Mvdeltac, has been awarded orphan drug designation by the FDA.
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Sarepta’s gene therapy gets boost with FDA platform designation

June 4, 2025
By Mari Serebrov
No Comments
The U.S. FDA gave Sarepta Therapeutics Inc.’s rAAVrh74 viral vector, used in an investigational gene therapy for the treatment of limb-girdle muscular dystrophy, a step up, making it one of the first platforms to receive the agency’s platform technology designation.
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Illustration of human body composed of molecules

FDA’s Makary vows in-house AI algorithm won’t leak data

June 3, 2025
By Mark McCarty
The U.S. FDA reported the launch of its in-house generative AI (GenAI) tool, dubbed Elsa, for a variety of purposes. FDA commissioner Marty Makary assuaged industry’s privacy concerns by promising that the algorithm does not train on data submitted by makers of devices and pharmaceuticals.
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Daiichi and Merck pull accelerated approval BLA for ADC

June 3, 2025
By Lee Landenberger
No Comments
Daiichi Sankyo Co. Ltd. and Merck & Co. Inc. have voluntarily pulled the BLA for accelerated approval tied to their HER3-directed antibody-drug conjugate (ADC) in treating EGFR-mutated non-small-cell lung cancer. The partnership in the expanding ADC space began nearly two years ago in a $22 billion deal.
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CSPC headquarters

CSPC hints at three upcoming deals worth $5B for EGFR ADC, others

June 3, 2025
By Marian (YoonJee) Chu
No Comments
CSPC Pharmaceutical Group Ltd. on May 30 disclosed that the company was engaged in ongoing negotiations with unnamed, independent third parties regarding three license deals and collaborations that could total up to $5 billion combined.
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Lung cancer driven by the Kras oncogene shown in purple
Cancer

Erasca’s pan-KRAS inhibitor ERAS-4001 gains IND clearance

June 3, 2025
No Comments
Erasca Inc. has obtained IND clearance by the FDA for ERAS-4001, an oral selective pan-KRAS inhibitor, for the treatment of patients with KRAS-mutant solid tumors.
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Bivacore TAH

Bivacor pumped by artificial heart’s breakthrough designation

June 2, 2025
By Annette Boyle
The U.S. FDA’s decision to grant breakthrough device designation for Bivacor Inc.’s titanium total artificial heart (TAH) sent real hearts aflutter at the Huntington, Calif.-based company’s headquarters. While the designation supports use of the TAH as a bridge to transplant for adults with biventricular or univentricular heart failure for whom current options are insufficient or unsuitable, Bivacor hopes its device will eventually serve as a long-term heart replacement.
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US flag, stock market chart, White House

White House budget proposal would cut FDA, slash NIH budgets

June 2, 2025
By Mark McCarty
The Trump administration released its budget proposal for fiscal year 2026, which would chop roughly 40% from the NIH budget over the current fiscal year — a proposal that might not find much support on Capitol Hill.
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