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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
Merck & Co. (MSD Outside U.S. and Canada) to Acquire Verona Pharma for $10 Billion, Expanding Respiratory Portfolio with Ohtuvayre®
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma”), a biopharmaceu...
July 04, 2025 | News
Cube Biotech Appoints Former Sartorius CEO Dr. Joachim Kreuzburg to Board of Directors
Cube Biotech GmbH announced the appointment of Dr. Joachim Kreuzburg, former CEO and Chairman of the Executive Board of Sartorius AG, to its Board of ...
July 10, 2025 | News
Univercells Technologies and Repligen Collaborate to Advance Real-Time Monitoring in Viral Vector and Vaccine Manufacturing
Univercells Technologies, a Donaldson Life Sciences business and global provider of bioprocessing solutions, announced a collaboration with Repli...
July 10, 2025 | News
FDA’s AI Transition Marks a Turning Point in Drug Review: Industry Faces Pressure to Adapt Amid 20% Workforce Cut
The FDA’s recent decision to cut its workforce by 20 percent has raised concerns across the biopharma industry, with experts warning of inevitable de...
July 09, 2025 | Opinion | By Lindsay Mateo, Chief Commercial Officer at Weave Bio
Bio-Rad Launches Four New ddPCR Platforms Following Stilla Technologies Acquisition
Bio-Rad Laboratories, Inc. (NYSE: BIO and BIO.B), a global leader in life science research and clinical diagnostics products, announced the launch of four ...
July 09, 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
Japanese Life Sciences Delegation Strengthens Collaboration with North Carolina’s Innovation Ecosystem
A high-level Japanese delegation specializing in life sciences concluded a three-day visit to North Carolina (June 24–26), further strengthening ties...
July 07, 2025 | News
Thermo Fisher Secures FDA Approval for Oncomine Dx Express Test as Companion Diagnostic for Dizal’s ZEGFROVY
Thermo Fisher Scientific, the world leader in serving science, announced the U.S. Food and Drug Administration (FDA) has approved the Oncomine&t...
July 04, 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
XtalPi Expands AI-Driven Drug Discovery Collaboration with Pfizer to Develop Next-Generation Molecular Modeling Platform
XtalPi (2228.HK), a leading global technology company in integrating artificial intelligence (AI) and robotics to advance the discovery of groundbreaking m...
June 30, 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
LTS and Nualtis Forge Strategic Alliance to Scale Oral Thin Film Drug Manufacturing Globally
LTS LOHMANN Therapie-Systeme AG (LTS), a leading pharmaceutical technology company, and Nualtis (formerly IntelGenx Corp.), an innovator in oral thin film ...
June 26, 2025 | News
Xcell Biosciences and Thermo Fisher Scientific Unite to Advance Treg and TIL Cell Therapies for Autoimmune and Solid Tumor Diseases
Xcell Biosciences (Xcellbio), a San Francisco-based instrumentation company focused on cell and gene therapy applications, today announced a strategic coll...
June 25, 2025 | News
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