Tiziana Life Sciences Announces Six-Month Qualitative Improvement in Neuroimaging in 80% of Multiple Sclerosis Patients Receiving Intranasal Foralumab
06 juin 2024 09h00 HE
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Tiziana Life Sciences Ltd.
Qualitative improvements in PET imaging seen in 80% of non-active Secondary Progressive Multiple Sclerosis (na-SPMS) Expanded Access patients receiving intranasal foralumab for at least 6-months.FDA...
FDA Provides Feedback and Reaches Consensus on Nexalin’s Design for Planned Anxiety and Insomnia Clinical Studies of its Gen-3 HALO Clarity™ Headset Device
03 juin 2024 08h30 HE
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Nexalin Technology, Inc.
HOUSTON, TX, June 03, 2024 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (the “Company” or “Nexalin”) (Nasdaq: NXL; NXLIW) announces that the U.S. Food and Drug Administration (FDA) has provided...
uniQure Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for Investigational Gene Therapy AMT-130 in Huntington’s Disease
03 juin 2024 07h05 HE
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uniQure Inc.
~ Designation based on 24-month interim Phase I/II clinical data for AMT-130 announced in December 2023 ~ ~ AMT-130 is the first therapeutic candidate to receive RMAT Designation for Huntington’s...
New AAMI Guidance on Combination Products and FDA CGMPs
30 mai 2024 08h47 HE
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AAMI
Arlington, Virginia, May 30, 2024 (GLOBE NEWSWIRE) -- As the breadth and scope of combination products around the world continues to ramp up, are U.S. manufacturers equipped with the best design...
Axogen Processing Center (APC) Celebrates its Opening with Ohio Leaders in Vandalia
28 mai 2024 16h30 HE
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Axogen, Inc.
ALACHUA, Fla. and TAMPA, Fla., May 28, 2024 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries,...
CKPT SHAREHOLDER ALERT: TOP RANKED ROSEN LAW FIRM Encourages Checkpoint Therapeutics, Inc. Investors to Secure Counsel Before Important June 4 Deadline in Securities Class Action – CKPT
23 mai 2024 12h38 HE
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The Rosen Law Firm PA
NEW YORK, May 23, 2024 (GLOBE NEWSWIRE) -- WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of Checkpoint Therapeutics, Inc. (NASDAQ: CKPT) between March...
Following Guidance from U.S. Food & Drug Administration in Type-C Meeting Lipella Pharmaceuticals to Advance Lead Product Candidate to Phase 2b
21 mai 2024 08h00 HE
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Lipella Pharmaceuticals Inc.
Following Guidance from U.S. Food & Drug Administration in Type-C Meeting Lipella Pharmaceuticals to Advance Lead Product Candidate to Phase 2b
Axogen Inc. Initiates Rolling Submission of Biologics License Application to U.S. Food and Drug Administration (FDA) for Avance Nerve Graft®
16 mai 2024 07h00 HE
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Axogen, Inc.
ALACHUA, Fla. and TAMPA, Fla., May 16, 2024 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries,...
Science 37 Metasite™ Undergoes Successful FDA Inspection, Marking Major Milestone in Virtual Site Quality Assurance and Compliance
13 mai 2024 08h00 HE
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Science 37, Inc.
Science 37 Holdings, Inc. today announced the preliminary outcome of its recent FDA Inspection focusing on critical areas and documentation.
Tiziana Life Sciences Files for Orphan Drug Designation for Intranasal Foralumab
13 mai 2024 07h00 HE
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Tiziana Life Sciences Ltd.
NEW YORK, May 13, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via...