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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, 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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China clears Mabwell’s Mailisheng injection to treat neutropenia

June 2, 2025
By Marian (YoonJee) Chu
No Comments
Mabwell (Shanghai) Bioscience Co. Ltd. on May 30 gained Chinese approval of Mailisheng (albipagrastim alfa; 8MW-0511) as a subcutaneous injection to treat febrile neutropenia induced by myelosuppressive anticancer treatment, such as radiotherapy and chemotherapy.
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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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1-30-Abbott-Tendyne.png

Abbott Tendyne TMVR secures FDA clearance

May 30, 2025
By Shani Alexander
Abbott Laboratories recently received FDA clearance for Tendyne, its transcatheter mitral valve replacement system. The news comes on the heels of Edwards Lifesciences Corp. securing a CE mark for its Sapien M3 system and is a boon for mitral valve therapies amid ongoing frustrations about the slow adoption of TMVR technologies.
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FDA Orange Book

Trump DOJ proposes less intrusive corporate prosecution

May 30, 2025
By Mark McCarty
The U.S. Department of Justice is reshuffling its enforcement focus for the coming three years per a May 12 memo attributed to Matthew Galeotti, director of the department’s criminal division. Galeotti said federal attorneys should avoid prosecutorial adventurism in an effort to strike what he described as “an appropriate balance” between enforcement and “unnecessary burdens on American enterprise.”
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New EOs impacting biopharma, med tech

May 30, 2025
No Comments
A dynamic chart of the latest executive orders (EOs) from the Trump administration that have been published in the Federal Register and that directly impact the biopharmaceutical and medical technology sectors.
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Product image

FDA greenlights Distalmotion’s Dexter for gallbladder removal

May 29, 2025
By Shani Alexander
The U.S. FDA granted 510(k) clearance to Distalmotion SA's Dexter, its surgical robotic system, for use in cholecystectomy in adults. The greenlight from the regulatory body is the second nod Dexter has received following de novo clearance granted in 2024 for use in inguinal hernia repair.
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U.S. Capitol building

FDA agrees to addition of policy experts at Q-sub meetings

May 29, 2025
By Mark McCarty
The U.S. FDA’s device guidance drought ended with the issuance of one draft and one final guidance, the latter of which deals with the Q-sub program for early interaction with sponsors of device applications. Per a request by industry, the agency indicated it is amenable to including FDA policy staff during these meetings, which may help to avoid surprises in premarket applications.
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