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Home » Topics » Regulatory » FDA

FDA
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Multiple myeloma illustration
Immuno-oncology

Brightpath’s BP-2202 designated orphan drug for multiple myeloma

July 4, 2025
No Comments
Brightpath Biotherapeutics Co. Ltd.’s iPS cell-derived BCMA CAR-natural killer T cell therapy candidate has been awarded orphan drug designation by the FDA for the treatment of multiple myeloma.
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Xray showing lung cancer on tablet

FDA approves Dizal’s sunvozertinib for metastatic non-small cell lung cancer

July 3, 2025
By Tamra Sami
No Comments
Four days ahead of its July 7 PDUFA date, the U.S. FDA granted accelerated approval to Dizal (Jiangsu) Pharmaceutical Co. Ltd.’s sunvozertinib (DZD-9008), branded as Zegfrovy, for treating adults with locally advanced or metastatic non-small-cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations following platinum-based chemotherapy.
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Multiple myeloma illustration

Regeneron wins FDA nod for BCMA bispecific Lynozyfic

July 2, 2025
By Jennifer Boggs
No Comments

It may be a year later than originally planned, but Regeneron Pharmaceuticals Inc. is set to commercialize Lynozyfic (linvoseltamab) in the U.S. following FDA approval for use in adults with relapsed and refractory multiple myeloma. A bispecific antibody targeting B-cell maturation antigen (BCMA) and CD3, Lynozyfic was cleared under the accelerated approval pathway, with continued approval contingent upon a confirmatory trial.


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Judge's gavel with US flag

Another court orders halt to US HHS reorganization

July 1, 2025
By Mari Serebrov
No Comments
Without using the words “universal” or “nationwide,” a U.S. district judge granted a preliminary injunction July 1 to stop the Department of Health and Human Services’ (HHS) reorganization plan, along with any workforce reduction that’s part of the plan.
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DNA and cancer cells
Cancer

Hemispherian’s GLIX-1 awarded US orphan drug designation for malignant glioma

July 1, 2025
No Comments
GLIX-1 is a first-in-class small-molecule therapeutic targeting DNA repair vulnerabilities in cancer cells.
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tissium

Tissium’s polymer solution set to transform nerve repair after FDA nod

June 30, 2025
By Shani Alexander
Could the U.S. FDA’s de novo marketing authorization for Tissium SA’s Coaptium Connect, an atraumatic sutureless solution for peripheral nerve repair, signal a transformative shift away from sutures in nerve surgery? Only time will tell.
Read More
Cyber security padlock

FDA retains non-statutory definition of cyber device in final guidance

June 30, 2025
By Mark McCarty
The U.S. FDA finalized the latest edition of its premarket cybersecurity guidance, but the agency is of the view that any device with software is subject to the terms of the guidance even though the statute would seem to exempt device software that lacks connectivity.
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Syringe in front of Moderna logo

With new flu data, Moderna reconsiders its COVID combo

June 30, 2025
By Lee Landenberger
No Comments
Solid phase III efficacy results for Moderna Inc.’s seasonal influenza vaccine, mRNA-1010, may lead the company to resubmit a BLA for a flu/COVID-19 combo shot it has been developing. The top-line data showed Moderna’s flu vaccine produced a superior relative efficacy that was 26.6% higher than a comparator standard-dose seasonal influenza vaccine in people ages 50 and older.
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Heart and DNA
Cardiovascular

FDA clears Rocket Pharmaceuticals’ IND for gene therapy candidate

June 30, 2025
No Comments
The U.S. FDA has cleared Rocket Pharmaceuticals Inc.’s IND application for RP-A701, an AAVrh.74-based gene therapy candidate for the treatment of BAG3-associated dilated cardiomyopathy (BAG3-DCM), a severe form of heart failure.
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Laptop displaying FDA logo

FDA waffles on post-assessment reports in final guidance for RRAs

June 27, 2025
By Mark McCarty
Industry’s reaction to the U.S. FDA’s draft guidance for remote regulatory assessments included a request for more clarity on when the agency would issue a post-assessment report, but the final guidance makes clear the FDA sees no compelling reason to issue such a report in every instance.
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