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News and Press Releases

Relmada Therapeutics Provides Regulatory Update Confirming FDA Alignment on Registrational Studies Design for NDV-01 for Two Separate Indications

FDA written feedback supports: a single-arm, open-label registrational trial in 2nd-line refractory high-grade NMIBC with CIS a randomized vs observation single trial in intermediate-risk NMIBC in the adjuvant setting Phase...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 12, 2026

Relmada Therapeutics
info@relmada.com
2222 Ponce de Leon Blvd. Floor 3 Coral Gables, FL 33134

Allogene Therapeutics Positions 2026 as a Program-Defining Year for Scalable, Real-World Allogeneic CAR T

1H 2026 Catalyst Stack Anticipated to Validate Scalable, Off-the-Shelf CAR T in Oncology and Autoimmune Disease Interim Futility Analysis of MRD Clearance from the Pivotal Phase 2 ALPHA3 Trial with...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 8, 2026

Allogene Therapeutics
210 E. Grand Avenue South San Francisco, CA 94080

AskBio Announces FDA Acceptance of Investigational New Drug (IND) Application for AB-1009 Gene Therapy for Treatment of Late-Onset Pompe Disease (LOPD)

AB-1009 program advances to Phase 1/Phase 2; clinical trial initiated in the United States Therapy granted United States Food and Drug Administration (FDA) Fast Track and Orphan Drug designations Pompe...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 8, 2026

AskBio
info@askbio.com
20 T.W. Alexander Drive Suite, 110 Research Triangle Park, NC 27709

T-CURX Announces $20M Series A First Closing Led by BiomedVC to Fund Pipeline of Clinical-Stage CAR-T Programs and Advance Proprietary Non-Viral In Vivo CAR-T Platform

17 December 2025 -- Würzburg, Germany -- T-CURX GmbH (T-CURX) today announces the first closing of a $20M (€ 17.7M) Series A financing with a syndicate of European and Asian investors...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: December 17, 2025

T-CURX
info@t-curx.com
Innovations- und Gründerzentrum Würzburg Friedrich-Bergius-Ring 15 97076 Würzburg Deutschland/Germany

Leucid Bio and Syenex Announce Strategic Collaboration for In Vivo CAR-T Cell Engineering

Enables in vivo delivery of LEU011 harnessing the VivoCell Platform 15 December 2025 -- London, UK and Illinois, US -- Leucid Bio, a privately-held biotechnology company developing innovative Chimeric Antigen Receptor...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: December 15, 2025

Leucid Bio
info@leucid.com
3rd Floor, Bermondsey Wing Guy's Hospital London SE1 9RT

AGC Biologics Partners with ATUM to Accelerate Timelines for Cell Line Development

New offering provides drug developers with flexible and powerful cell line development options for monoclonal antibodies, multi-specific and complex molecules   2 December 2025 -- Washington State, US -- As drug developers face increasing pressure to lower...

Category: Biotechnology, Drug Discovery, Other, Pharmaceutical
Posted: December 2, 2025

AGC Biologics
contactus@agcbio.com

Infant Bacterial Therapeutics AB secures partnership with Recipharm Advanced Bio for commercial production of drug substance

IBP-9414 targets mortality and gastrointestinal injury in premature infants With Breakthrough Therapy designation for gastro-intestinal mortality and Rare Paediatric Disease designations, IBP-9414 is on an accelerated path to commercialisation   PPQ...

Category: BioManufacturing, Logistics, Manufacturing and Packing, Other, Pharmaceutical
Posted: December 1, 2025

Recipharm

Telomir and Mira Pharmaceuticals advance through key development milestones with Recipharm support

Telomir-1 has now entered GMP preparation, and Ketamir-2 has completed the Phase 1 SAD stage, reflecting steady advancement of both programmes These milestones mark tangible progress in development and demonstrate...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: November 26, 2025

Recipharm

Jemperli®▼(dostarlimab) with platinum-based chemotherapy to be made available on the NHS for all eligible patients in England for first-line treatment of primary advanced or recurrent endometrial cancer

Jemperli (dostarlimab) with platinum-based chemotherapy to be made available on the NHS for all eligible patients in England for first-line treatment of primary advanced or recurrent endometrial cancer Following a...

Category: Drug Delivery, Other, Pharmaceutical
Posted: November 25, 2025

GSK
980 Great West Rd, London TW8 9GS

CARBOGEN AMCIS Announces Successful Refinancing and Enhancement of their Syndicated Credit Facilities to Support Continued Growth and Investment

12 November 2025 -- Bubendorf, Switzerland -- CARBOGEN AMCIS, a subsidiary of Dishman Carbogen Amcis, and a global top-tier Contract Development and Manufacturing Organisation (CDMO), today announced the successful refinancing and...

Category: BioManufacturing, Manufacturing and Packing, Other, Pharmaceutical
Posted: November 12, 2025

CARBOGEN AMCIS
info@carbogen-amcis.com
Hauptstrasse 171 CH-4416 Bubendorf Switzerland

Commit Biologics achieves proof-of-concept for novel Complement Engager platform in non-human primates

Novel approach harnessing the power of the complement system to drive potent cell depletion Single-dose study shows rapid and sustained immune cell depletion in blood and tissues with a very...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: November 11, 2025

Commit Biologics
info@commitbio.com
Universitetsbyen 83 8000 Aarhus C, Denmark

Heidelberg Pharma’s Lead ATAC Candidate HDP-101 Shows Progress in Phase I/IIa Trial in Multiple Myeloma

Evidence of clinical activity observed in Cohort 8, including stringent complete remission in two patients from Cohort 8 HDP-101 continues to demonstrate a favorable safety profile with no dose-limiting toxicities...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: November 6, 2025

Heidelberg Pharma
info@hdpharma.com
Gregor-Mendel-Straße 22 68526 Ladenburg Deutschland

Ryvu Therapeutics Announces Three Abstracts on Romaciclib (RVU120) and One Abstract on Dapolsertib (MEN1703) at the 2025 ASH Annual Meeting

Romaciclib continues to show efficacy in AML: Data from the Phase II RIVER-81 trial suggest that romaciclib restores sensitivity to venetoclax in resistant AML, inducing complete remissions with a favorable safety profile Clinical activity in myelofibrosis (MF): Interim results from the Phase II POTAMI-61 study indicate clinically meaningful spleen volume...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: November 3, 2025

Ryvu Therapeutics
ryvu@ryvu.com
R&D Center for Innovative Drugs Leona Henryka Sternbacha 2 30-394 Kraków, Poland

Ryvu Therapeutics Presents RVU305 (PRMT5i) and ONCO Prime Platform Data at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

RVU305, a potentially best-in-class, brain-permeable MTA-cooperative PRMT5 inhibitor, demonstrates strong and selective antitumor efficacy in MTAP-deleted glioblastoma models, with confirmed brain exposure and a favorable safety profile supporting IND/CTA-enabling studies...

Category: Biotechnology, Drug Discovery, Other, Pharmaceutical
Posted: October 27, 2025

Ryvu Therapeutics
ryvu@ryvu.com
R&D Center for Innovative Drugs Leona Henryka Sternbacha 2 30-394 Kraków, Poland

Naobios and Tokyo Metropolitan Institute of Medical Science partner to develop new live-attenuated vaccine against mpox

 Partnership aims to commercialize new mpox vaccine - with higher level of safety - by 2027 23 October 2025 -- Nantes, France, and Tokyo, Japan -- Naobios, a CDMO (Contract Development...

Category: BioManufacturing, Drug Delivery, Manufacturing and Packing, Other, Pharmaceutical
Posted: October 23, 2025

Naobios
Operating office 6 rue Alain Bombard 44800 Saint-Herblain