Fapon Biopharma Announces FDA Approval of IND for FP008, a First-in-Class Immunotherapy for Solid Tumors
Fapon Biopharma, a biotech innovator in developing therapeutic antibodies and fusion proteins, is pleased to announce that the U.S. Food and Drug ...
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Doron’s biologic osteoarthritis treatment gets FDA boost
Doron Therapeutics, a clinical-stage biotechnology company based in Chapel Hill, has received a Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration ...
Instylla Completes Submission of Premarket Approval Application for Embrace™ Hydrogel Embolic System
Instylla, Inc., a privately held clinical-stage company developing solutions for peripheral vascular embolotherapy, announced that it recently submitted to the U.S. Food and Drug Administration (FDA) ...
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VIBATIV® RECEIVES MARKETING APPROVAL IN CHINA
NASHVILLE, Tenn. and SHANGHAI, Feb. 18, 2025 /PRNewswire/ -- Specialty pharmaceutical companies Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) and SciClone Pharmaceuticals (Holdings) Limited ...
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U.S. FDA Accepts Gilead’s New Drug Applications for Twice-Yearly Lenacapavir for HIV Prevention Under Priority Review
The safety and efficacy of this use has not been established by the U.S. FDA. There is currently no cure for HIV or AIDS. About Lenacapavir Lenacapavir is approved in multiple countries for the ...
Avobis Bio Receives FDA Fast Track Designation for AVB-114 Implantable Cell Therapy for Crohn's Perianal Fistulas
Avobis Bio LLC, a clinical stage company developing implantable cell therapies, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for AVB-114, the ...
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Jazz Pharmaceuticals to acquire Chimerix for $935M
From 2019-2023, North Carolina increased the number of life sciences business establishments by 43%. To learn more in the TEConomy 2024 report, click here.
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What’s the Difference Between the FDA and the USDA?
The FDA’s logo doesn’t appear on the millions of nutrition labels it approves each year.) The FDA does not itself inspect restaurants, but in addition to green-lighting the packaged food ...
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FDA Accepts BLA For TLX250-Cdx (Zircaix®) For Kidney Cancer Imaging, Grants Priority Review
MELBOURNE, Australia, Feb. 26, 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX , Telix, the Company) today announces that the United States (U.S.) Food and Drug ...
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Senseonics Holdings, Inc. Reports Fourth Quarter and Full Year 2024 Financial Results
Fourth Quarter 2024 Results: Total revenue for the fourth quarter of 2024 was $8.3 million compared to $8.0 million for the fourth quarter of 2023. U.S. revenue was $6.2 million for both the fourth ...