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14,036 Results for "505".
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Press Releases
AP Biosciences and Tasly Finalize Amended Collaboration Agreement to Support Global Out-Licensing of AP505 (B1962)
March 30, 2026
·
3 min read
Press Releases
Zydus and RK Pharma enter into an exclusive licensing and commercialization agreement for a novel 505(b)(2) product of supportive oncology treatment for the USA market
November 27, 2025
·
3 min read
Press Releases
PharmaTher Announces KetAImine(TM) - AI Discovery Platform to Expand the Ketamine Portfolio, Enable Earlier Partnering, and Fast-Track 505(b)(2) NDA Filings
Expanding ketamine indications, fortifying IP, enabling earlier partnerships, and accelerating FDA pathways - underpinned by PharmaTher’s Digital Health AI division, leveraging the Company’s FDA-approved ketamine ANDA CMC and KetaVault(TM) data advantage.
October 15, 2025
·
7 min read
Press Releases
PharmaTher Applauds FDA’s Commissioner’s National Priority Voucher (CNPV) Selection of Ketamine; Company Highlights Potential Ketamine Opportunity, 505(b)(2) Focus, and Upside from Strategic ANDA Sale
October 17, 2025
·
8 min read
Press Releases
Serina Therapeutics Announces FDA Feedback Supports Registrational Trial Design of SER-252 in Advanced Parkinson’s Disease under 505(b)(2) NDA Pathway
August 26, 2025
·
7 min read
Press Releases
PharmaTher Advances Phase 3 FDA Package for Ketamine in LID-Parkinson’s Disease
Company preparing FDA meeting package to align on a single, well-controlled Phase 3 study under 505(b)(2); Pharma partner discussions ongoing
October 16, 2025
·
6 min read
Press Releases
Apotex introduces IVRA™ (Melphalan) hydrochloride injection: First ready to dilute liquid formulation of Melphalan injection approved via 505(b)(2) NDA in the United States
May 9, 2025
·
1 min read
Press Releases
LadRx Planning NDA Submission under 505(b)(2) for Aldoxorubicin and Other Updates
December 11, 2024
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1 min read
Sensorion Announces a €50.5 Million Financing With Participation From New and Existing US and European Healthcare Specialist Investors
Sensorion announced a €50.5 million offering reserved to specific categories of investors through the issuance of 88,594,737 new ordinary shares of the Company at a price per New Share of €0.57 to the benefit of Redmile Group, Invus and Sofinnova Partners, existing shareholders, and leading US Healthcare Specialists funds including Aquilo Capital, as well as two large investment management firms.
February 9, 2024
·
14 min read
FDA
Amneal Receives 505(b)(2) NDA Approval from FDA for PEMRYDI RTU®, a Ready-to-Use Oncology Injectable
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced the 505(b)(2) New Drug Application (NDA) approval from the U.S. Food and Drug Administration (“FDA”) for PEMRYDI RTU®.
June 14, 2023
·
6 min read
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