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Regulatory
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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).
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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.
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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.
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Regulatory actions for Oct. 20, 2023

Oct. 20, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Pleural Dynamics.
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Streptococcus pneumoniae in lungs
Immune

Vaxcyte's 31-valent PCV candidate VAX-31 receives IND clearance for invasive pneumococcal disease

Oct. 20, 2023
Vaxcyte Inc. has received FDA clearance of its IND application for VAX-31, a 31-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease.
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Salary disparities land Pfizer with $2M back tab

Oct. 19, 2023
Pfizer Inc. entered into a conciliation agreement with the U.S. Department of Labor’s Office of Federal Contract Compliance Programs to resolve alleged compensation discrimination affecting female employees at its New York headquarters.
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