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  • STRATEGY

    Smarter Pharma

    Quality management systems QMS are the backbone of pharmaceutical manufacturing ensuring safe products

  • EXPERT Talk

    From Compliance to Competitive Advantage

    Compliance gets you through an audit Resilience gets medicines to patients on the day something unexpected happens The DSCSAs enhanced requirements took effect November but real interoperability required three more rounds of accommodation phased implementation with the smalldispenser

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TOP ARTICLES

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Johnson & Johnson Announces Collaboration with Sail Biomedicines to Advance in vivo CAR-T Programs and Transform Autoimmune Disease Through Immune Reset

Johnson Johnson NYSE JNJ today announced strategic agreements and collaboration with Sail Biomedicines Sail a biotechnology company developing in vivo CART therapies for immunemediated diseases

AbCellera Announces Collaboration with Vertex to Discover Multispecific T-Cell Engagers for Autoimmune Diseases and Other Conditions

AbCellera Nasdaq ABCL today announced a collaboration with Vertex Pharmaceuticals Incorporated Nasdaq VRTX to research develop manufacture and commercialize multispecific Tcell engagers

Evinova Launches Strategic Partnership with Merck KGaA, Darmstadt, Germany to Define the Future of Clinical Development

Evinova a global leader in AInative clinical development technology today announced a new multiyear strategic collaboration to accelerate global clinical development with Merck KGaA Darmstadt Germany

Clean Cells acquires Anaquant to expand analytical capabilities in biomanufacturing quality control

Clean Cells a leading biopharmaceutical quality control services provider specializing in biologics GMP testing and a member of the Clean Biologics Group today announces its acquisition of Anaquant

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Jul 2026

ADLM 2026

Anaheim, CA USA

28 - 30

Jul 2026

5th In Vivo Cell & Gene Summit 2026

500 Commonwealth Avenue, Bosto...

11 - 12

Aug 2026

19 - 21

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Aug 2026

LATEST NEWS Read more...

Allogene Therapeutics Gains FDA RMAT and Fast Track Status for Cema-Cel in First-Line Large B-Cell Lymphoma

Allogene Therapeutics has received Regenerative Medicine Advanced Therapy RMAT and Fast Track designations from the US Food and Drug Administration FDA for its investigational allogeneic CAR T therapy

Ocugen Receives FDA RMAT Designation for OCU410 in Geographic Atrophy

Ocugen has received Regenerative Medicine Advanced Therapy RMAT designation from the US Food and Drug Administration FDA for its investigational gene therapy OCU for the treatment of geographic atrophy

Eton Pharmaceuticals Seeks FDA Approval to Expand KHINDIVI Use in Younger Children

Eton Pharmaceuticals has submitted a Prior Approval Supplement PAS to the US Food and Drug Administration FDA seeking to expand the approved use of KHINDIVI hydrocortisone oral solution

Dyne Therapeutics Receives FDA Clearance to Begin Phase 1 Trial of DYNE-302 for FSHD

Dyne Therapeutics has received clearance from the US Food and Drug Administration FDA for its Investigational New Drug IND application to begin a Phase clinical trial of DYNE for the treatment of facioscapulohumeral

Antag Therapeutics Doses First Patient in Phase 2a Trial of AT7687 for Obesity and Type 2 Diabetes

Antag Therapeutics has dosed the first participant in its Phase a clinical trial evaluating AT a firstinclass glucosedependent insulinotropic polypeptide receptor GIPR antagonist in combination

HAYA Therapeutics Receives FDA Fast Track Designation for HTX-001 in Non-Obstructive Hypertrophic Cardiomyopathy

HAYA Therapeutics has received Fast Track designation from the US Food and Drug Administration FDA for HTX its investigational therapy for the treatment of symptomatic nonobstructive hypertrophic cardiomyopathy nHCM