FDA gives first RMAT designation to a cardiac gene therapy
A regenerative medicine advanced therapy (RMAT) designation has been given to a gene therapy for Danon disease by the US Food and Drug Administration (FDA).
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A regenerative medicine advanced therapy (RMAT) designation has been given to a gene therapy for Danon disease by the US Food and Drug Administration (FDA).
Forxiga (dapagliflozin) has been approved in the EU for chronic heart failure across the full spectrum of left ventricular ejection fraction.
MSD/Merck and Nectin Therapeutics have agreed to collaborate on a clinical trial for KEYTRUDA® in combination with monoclonal antibody NTX1088.
A potentially first-in-class PKC theta inhibitor, in development for immunology and inflammation indications, has entered first-in-human trials in the US.
A novel, first-in-class oral therapy showed meaningful improvement in over half of scleroderma patients in a Phase II trial for serious inflammatory and fibrotic diseases.
An interim analysis of a Phase III trial showed pembrolizumab plus chemotherapy significantly improved survival in endometrial cancer.
The Association of the British Pharmaceutical Industry (ABPI) has urged immediate government action is needed against the planned UK statutory revenue clawback rate rise for branded medicines.
Virtual seminar presented by Ziva Abraham, President, and CEO of Microrite designed to improve your understanding on current regulatory thinking on designing an effective contamination control strategy.
The MHRA has approved the first marketing authorisation globally for the use of RINVOQ®▼ (upadacitinib) in Crohn's disease.
AMJEVITA™, the first biosimilar to Humira® is now available in the US, based on four years of real-world experience in over 300,000 patients.
1 February 2023 | By ACG Associated Capsules Pvt. Ltd
Watch this webinar on capsule-based dry powder inhalers (cDPI) to discover how capsules work as a unit dosage form for the inhalation-based delivery of the active pharmaceutical ingredients.
Use of the Clinical Trials Information System is now mandatory for new clinical trial applications in the EU, says the European Medicines Agency.
The poster summarises the relevant key elements when selecting titration electrodes when switching from manual to automated titration.
A positive opinion has been adopted by the CHMP for a citrate-free high concentration formulation of its biosimilar Hyrimoz® (adalimumab).
Based on recent research, a "potential game changer” approach could offer a practical way to use monoclonal antibody therapies for malaria in Africa.