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Chime Biologics and Mabgeek Achieve Major Milestone with PPQ Completion for MG-K10 Antibody

Process Performance Qualification (PPQ) validates robust manufacturing standards and is crucial for regulatory compliance Marks a key step forward for t...

January 06, 2025 | News

Capricor Therapeutics Submits BLA for Deramiocel, Poised to Become First Approved Therapy for DMD Cardiomyopathy

If approved, deramiocel would be first approved therapy for Duchenne muscular dystrophy cardiomyopathy- -BLA submission triggers $10 million milestone pay...

January 03, 2025 | News

RenovoRx Strengthens IP Portfolio with 18 Issued and 13 Pending Patents as it Advances TAMP™ Therapy and RenovoCath Commercialization

RenovoRx Holds a Strong IP Portfolio with 18 Issued Patents and 13 Pending Patents as it Moves Forward with Commercialization and Clinical Trial Plan...

January 02, 2025 | News

Inogen Secures FDA Clearance for SIMEOX 200 Airway Clearance Device

Inogen, Inc. (Nasdaq: INGN), a medical technology company offering innovative respiratory products for use in the homecare setting, announced tha...

January 02, 2025 | News

Sangamo Therapeutics Regains Rights to Hemophilia A Gene Therapy After Pfizer Ends Collaboration

Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today announced it will regain development and commercialization rights to giroctoco...

January 02, 2025 | News

Verastem Oncology’s NDA for Avutometinib-Defactinib Combo in KRAS Mutant LGSOC Accepted by FDA with Priority Review

Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, announced that the U.S. Food a...

January 02, 2025 | News

Innovent Biologics and Roche Forge Strategic Alliance to Advance DLL3-Targeted ADC for Small Cell Lung Cancer

Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality me...

January 02, 2025 | News

I Peace Achieves Milestone of Manufacturing 100 GMP-Grade iPS Cell Lines

Leading GMP cell CDMO I Peace, Inc., specializing in induced pluripotent stem cells (iPSCs) and iPSC-derived cell therapies, announced that the n...

December 31, 2024 | News

Exicure Signs MOU to Acquire GPCR USA and Advance Collaborative Research in Drug Development

Exicure, Inc. (Nasdaq: XCUR, “Exicure”, “the Company”), has announced the signing of a Memorandum of Understanding (MOU) with GPCR ...

December 30, 2024 | News

WuXi AppTec Divests Advanced Therapies Unit Amidst US BioSecure Act Scrutiny in Strategic Deal with Altaris, LLC

WuXi AppTec, a global company that provides a broad portfolio of R&D and manufacturing services to enable companies in the pharmaceutical and life scie...

December 27, 2024 | News

BioPharma America: The Exclusive News Portal for the U.S. Biopharma Industry

The biopharmaceutical landscape in the United States now has its dedicated media hub - BioPharma America. Designed as the premier destination for all ...

December 24, 2024 | News

New Therapeutics Venture GEMMABio Secures $34M in Seed Funding to Accelerate Gene Therapy Initiatives

Significant international investment defies sector trend GEMMA Biotherapeutics ("GEMMABio") – a new therapeutics company founded by gene therapy pio...

December 24, 2024 | News

Vertex Announces FDA Approval of ALYFTREK™: A Once-Daily CFTR Modulator for Cystic Fibrosis Patients Aged 6 and Older

ALYFTREK™ is approved for patients 6 years and older with at least one responsive mutation, including 31 additional mutations not re...

December 23, 2024 | News

PeproMene Bio Secures $11M Investment to Advance BAFF-R CAR T Therapy for Relapsed Follicular Lymphoma

Based on promising early clinical results from PeproMene Bio's PMB-102 Phase 1 study, they will receive $6M USD upfront plus an addit...

December 20, 2024 | News

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