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Home » Topics » Regulatory

Regulatory
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Concept art for "cancer cells destroyed by oncogenic virus"
Immuno-oncology

FDA clears IND for systemic oncolytic vaccinia virus therapy ASP-1012 for solid tumors

Oct. 24, 2023
Kalivir Immunotherapeutics Inc. has announced FDA clearance of an IND application for a phase I study of ASP-1012 (formerly VET2-L2) in participants with locally advanced or metastatic solid tumors. The trial is expected to begin in the first quarter of next year.
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Illustration comparing healthy vs. Huntington's disease neuron and brain
Neurology/Psychiatric

Skyhawk’s RNA splicing modifier for Huntington’s disease cleared for Australian trial

Oct. 24, 2023
Skyhawk Therapeutics Inc. has obtained Australian human research ethic committee (HREC) approval to conduct a phase I trial of SKY-0515 for Huntington’s disease.
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Pipet, test tubes, chemical structures
Cancer

Kancera’s fractalkine-blocking candidate cleared in Finland for phase I trial

Oct. 24, 2023
The Finnish regulatory agency (FIMEA) has approved Kancera AB’s application to conduct a phase I study of KAND-145, the company’s second-generation fractalkine-blocking candidate drug for cancer.
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Diagram showing parts of the eye
Ocular

Endogena Therapeutics’ candidate for geographic atrophy receives FDA clearance to enter clinic

Oct. 24, 2023
Endogena Therapeutics Inc. has received FDA clearance of its IND application for EA-2351 for geographic atrophy, an advanced form of age-related macular degeneration (AMD).
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Seastar gets third breakthrough nod for Selective Cytopheretic device

Oct. 23, 2023
Seastar Medical Holding Corp. was granted a third breakthrough device designation by the U.S. FDA for its Selective Cytopheretic device (SCD), a biomimetic membrane-based device used to treat patients with acute inflammatory conditions, which can cause organ failure and death. The latest designation is for its use in patients with hepatorenal syndrome. It follows other indications including cardiorenal syndrome and in adults with acute kidney injury (AKI).
Read More
U.S. White House

Biotech, med tech big winners in US tech hub program

Oct. 23, 2023
By Mari Serebrov
With an eye on increasing U.S. competitiveness and expanding the opportunities of technology hubs beyond those already established on the country’s two coasts, the Biden administration designated 31 communities, out of more than 370 applicants, as Regional Innovation and Technology Hubs.
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Laptop displaying FDA logo

US FDA revises guidance on sharing off-label scientific info

Oct. 23, 2023
By Mari Serebrov
The U.S. FDA is once again revising its guidance on how drug and device makers can share scientific reprints and reference texts with health care providers regarding off-label uses of their approved or cleared products.
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Regulatory actions for Oct. 23, 2023

Oct. 23, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Insulet, Huizhou Jinghao, Ludica Medical, Medtronic, Vuno.
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Pfizer wins FDA nod for pentavalent meningitis vaccine Penbraya

Oct. 20, 2023
By Randy Osborne
The U.S. FDA cleared Pfizer Inc.’s Penbraya (meningococcal groups A, B, C, W and Y vaccine), the first pentavalent shot designed to provide coverage against the most common serogroups causing meningococcal disease in adolescents and young adults through age 25.
Read More
FDA Approved stamp with pills, bottle, blister pack
Biopharma regulatory actions and approvals September 2023

2023 US FDA approvals rise over last year, yet fall short of earlier years

Oct. 20, 2023
By Amanda Lanier
The first three quarters of 2023 delivered a mix of approval news, with an uptick in U.S. FDA clearances over the previous year, but still tracking lower than 2017-2021. Global approvals are on a different trajectory, down year over year.
Read More
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