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    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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CREATE Medicines Expands Targeted In Vivo CAR Platform Through Strategic Research Collaboration and Exclusive License Agreement with Monash University

CREATE Medicines Inc CREATE a clinicalstage biotechnology company pioneering in vivo immune programming today announced a strategic research collaboration with Australias Monash University

Relation Announces Expanded Collaboration with GSK

Relation today announced a strategic research collaboration with GSK focused on generating largescale human cellular perturbation data and deploying them into models including MORGAN

Resilience and Lilly Invest $750 Million to Increase U.S.-Manufactured Medicine Supply

Resilience a technologyforward contract development and manufacturing organization dedicated to broadening access to complex medicines today announced it has expanded its strategic partnership with Eli Lilly and Company

MiRecule Announces Strategic Collaboration with EMS Group Company Rio Biopharma to Advance Targeted Delivery of RNA Therapeutics

MiRecule Inc a biotechnology company developing nextgeneration RNA therapeutics for rare genetic diseases today announced a strategic research collaboration with Rio Biofarma Brasil Ltda RBBL

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Novo Nordisk Updates on ZEUS Phase 3 Trial of Ziltivekimab

Novo Nordisk has announced headline results from the Phase ZEUS cardiovascular outcomes trial evaluating ziltivekimab in people with atherosclerotic cardiovascular disease ASCVD chronic kidney disease CKD and inflammation

FDA and EMA Accept Applications for Polpharma Biologics' Vedolizumab Biosimilar PB016

Polpharma Biologics has announced that the US Food and Drug Administration FDA and the European Medicines Agency EMA have accepted for review its Biologics License Application BLA

Abivax Advances NDA Plans for Obefazimod Following Positive FDA Meeting

Abivax has completed a positive preNew Drug Application NDA meeting with the US Food and Drug Administration FDA for obefazimod its investigational treatment for adults with moderately to severely active ulcerative colitis UC

Iksuda Receives FDA Clearance to Begin Phase I Trial of IKS04

Iksuda Therapeutics has received Investigational New Drug IND clearance from the US Food and Drug Administration FDA for IKS allowing the company to begin a Phase I clinical trial in patients with gastrointestinal GI cancers

FDA Grants Orphan Drug Designation to Enzomenib for Acute Lymphoblastic Leukaemia

Sumitomo Pharma America has announced that the US Food and Drug Administration FDA has granted Orphan Drug Designation to enzomenib DSP for the treatment of patients with acute lymphoblastic leukaemia ALL

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