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    Inside the Approval Timeline: Where Programs Really Lose Months

    Ask a development team why their program slipped two quarters and youll usually hear about the obvious culprits a clinical hold an unexpected safety signal a manufacturing deviation These are the losses that get postmortems and steeringcommittee attention But they are not in aggregate where most programs surrender their timeline

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Galibra Neuroscience Receives FDA Orphan Drug and Rare Pediatric Disease Designations for SSADH Deficiency Gene Therapy

Galibra Neuroscience announced a significant regulatory milestone with the receipt of both Orphan Drug Designation ODD and Rare Pediatric Disease Designation RPDD from the US Food and Drug Administration

Damora Therapeutics Initiates Phase 1/1b CLARITY-101 Clinical Trial of DMR-001 in Patients with Mutant Calreticulin-Driven Essential Thrombocythemia and Myelofibrosis

Damora Therapeutics Inc NASDAQ DMRA a biotechnology company working to fundamentally redefine care for patients with blood disorders today announced the initiation of the global Phase b CLARITY clinical trial of DMR

Moderna Receives U.S. FDA Approval for Influenza Vaccine mFLUSIVA

Moderna Inc NASDAQMRNA today announced that the US Food and Drug Administration FDA has approved mFLUSIVA mRNA a new vaccine against seasonal influenza

Moderna Announces Initiation of Phase 1 Clinical Trial of mRNA-1469, Moderna's Investigational Vaccine Against Bundibugyo Ebolavirus

Moderna Inc NASDAQMRNA today announced that following Health Canadas authorization of the study the first participants have been vaccinated in a Phase clinical study in Canada evaluating

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CPHI Korea 2026

COEX, Seoul, Korea

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Aug 2026

BIOMEDevice 2026

Boston Convention & Exhibition...

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Sep 2026

5th MENA Congress for Rare Diseases 2026

Beach Rotana Hotel, Abu Dhabi,...

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Schrödinger and Bristol Myers Squibb expand collaboration to deploy AI co-scientist for drug discovery

Schrdinger has entered into a strategic collaboration and software agreement with Bristol Myers Squibb BMS to deploy its agentic AI coscientist Bunsen across the companys research organisation to support drug discovery

US FDA approves Takeda's ORZEYFUL for narcolepsy type 1

Takeda has received approval from the US Food and Drug Administration FDA for ORZEYFUL oveporexton making it the first and only treatment approved to address the underlying cause of narcolepsy type NT in adults

Lunai Bioworks partners with BrainStorm Therapeutics to advance precision therapies for Parkinson’s disease

Lunai Bioworks has signed a definitive collaboration agreement with BrainStorm Therapeutics to advance the discovery of diseasemodifying therapies for Parkinsons disease The companies are targeting an initial data readout from the collaboration in the first half of

SHY Therapeutics doses first patient in Phase 1 trial of SHY-ONC6 for solid tumours

SHY Therapeutics has dosed the first patient in its firstinhuman Phase clinical trial evaluating SHYONC an investigational oral proteasome inhibitor for the treatment of advanced solid tumours The company expects to report initial Phase data in

Taysha Gene Therapies and Catalent Expand Partnership for Future Commercial Manufacturing of TSHA-102

Taysha Gene Therapies and Catalent have expanded their strategic partnership through a commercial supply agreement for TSHA Tayshas investigational gene therapy for Rett syndrome

Pathos AI Signs Global Licensing Agreement with Alphamab Oncology for JSKN016 Bispecific ADC

Pathos AI has entered into a global licensing agreement with Jiangsu Alphamab Biopharmaceuticals a wholly owned subsidiary of Alphamab Oncology for JSKN a firstinclass TROPHER bispecific