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Home » Topics » Regulatory » FDA

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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US flag, gavel, book

FDA declines to appeal court loss in LDT litigation

June 2, 2025
By Mark McCarty
The U.S. FDA declined to appeal the outcome of a lawsuit eviscerating the agency’s final rule for regulation of lab-developed tests despite a 60-day window to do so.
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Colorful illustration of the heart
Cardiovascular

Circode Biomed’s HM-2002 gains US IND clearance for ischemic heart disease

June 2, 2025
No Comments
Shanghai Circode Biomed Co. Ltd. has obtained IND clearance from the FDA for HM-2002 for ischemic heart disease. It previously received IND clearance in China in January this year.
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CSPC headquarters

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

May 30, 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.
Read More
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