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FDA Publishes First-Ever Public Database of Complete Response Letters (2020–2024) – Now Available for Download

Download Approved CRLs – 2020 to 2024 (external link) U.S. Food and Drug Administration (FDA) has, for the first time, made pub...

July 14, 2025 | Regulatory

Amarna Therapeutics and NorthX Biologics Advance Nimvec™ AM510 Toward Clinical Trials for Type 1 Diabetes

Fast-Tracking Clinical Readiness: The agreement enables process and analytical development activities required to advance Nimvec™ AM510 for Type 1 ...

July 14, 2025 | News

Sartorius Stedim Biotech and Sensible Biotechnologies Forge Alliance to Scale Cell-Based mRNA Manufacturing

Sartorius Stedim Biotech, a leading international partner of the biopharmaceutical industry, and Sensible Biotechnologies, a pioneer in cell-based design a...

July 11, 2025 | News

BioMed X and Servier Launch Europe’s First XSeed Labs at Paris-Saclay to Accelerate AI-Driven Bispecific Antibody Design

BioMed X, an independent biomedical research institute based in Heidelberg, Germany, announced the launch of a new initiative with Se...

July 10, 2025 | News

ImmunityBio Secures First International Approval for ANKTIVA® in the UK for Bladder Cancer Treatment

ANKTIVA, a first-in-class, lymphocyte-stimulating agent, works synergistically with BCG to activate and proliferate natural killer (NK) and T cells, he...

July 08, 2025 | News

Biosynth Expands GMP Bioconjugation Facility in Berlin to Advance Next-Generation Therapeutics

Biosynth, a leading developer and supplier of critical raw materials and services for life sciences and diagnostics, is pleased to announce the openi...

July 07, 2025 | News

Sartorius Finalises Acquisition of MatTek and Visikol to Bolster Cell Technology Portfolio

The life science group Sartorius has successfully closed the acquisition of MatTek Corp, including Visikol Inc, from the Swedish BICO ...

July 03, 2025 | News

Switzerland’s RDP Pharma and Singapore’s A*STAR EDDC Join Forces to Develop Precision Autoimmune Therapies

RDP Pharma AG, a Swiss biotechnology company focused on next-generation protein degradation therapeutics, and the Experimental Drug Development...

July 02, 2025 | News

Takara Bio Europe Partners with MACHEREY-NAGEL to Distribute Bioanalysis Portfolio Across Europe

Takara Bio Europe is pleased to announce it has entered into a distribution agreement with MACHEREY-NAGEL (MN), a leading global provider of analytical and...

July 02, 2025 | News

Vetter Breaks Ground on New Clinical Manufacturing Site in Illinois to Expand U.S. Operations

Production site expected to be fully operational by the end of 2029 Modern site with holistic approach for state-of-the-art manufacturing operations Fu...

June 30, 2025 | News

Porton Advanced and EVA Pharma Partner to Boost CAR T-Cell Therapy Manufacturing in the Middle East and Africa

Porton Advanced Solutions, a global leading cell and gene therapy CDMO service provider, and EVA Pharma, one of the leading pharmaceutical companies d...

June 27, 2025 | News

Duke Street Bio Secures FDA Fast Track Designation for DSB2455 in TNBC-Related Brain Metastases

Duke Street Bio, a clinical-stage biotechnology company focused on precision oncology, announced that the U.S. Food and Drug Administration (FDA) has...

June 25, 2025 | News

Leica Microsystems Launches Personalised Online Storefront for UK Customers

Leica Microsystems, a Danaher company and a leading provider of microscopy and scientific solutions, has expanded its online shopping experience to the Uni...

June 25, 2025 | News

EVA Pharma and CHICO Pharmaceutical Join Forces to Localize Oncology API Production for Middle East and Africa

On the sidelines of CPHI China 2025, EVA Pharma, one of the leading pharmaceutical companies driving healthcare innovation and access across the Middle Eas...

June 25, 2025 | News

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