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Multiple myeloma treatment receives IND from FDA
The FDA has granted Investigational New Drug (IND) authorisation to KP1237 for the treatment of multiple myeloma using a patient's own Natural Killer cells.
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US Food and Drug Administration (FDA)
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FDA approves AUDENZ™, an adjuvanted Influenza A pandemic vaccine
The US FDA has approved AUDENZ, a vaccine formulated with MF59® adjuvant, as an Influenza A H5N1 vaccine that can be quickly deployed in the event of a pandemic.
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Efficient Laboratories Inc recalls flu treatment due to contamination
Rompe Pecho EX, Rompe Pecho CF and Rompe Pecho MAXliquid are being recalled due to microbial contamination.
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FDA approves Palforzia for treatment of peanut allergy in children
Palforzia, a peanut allergen powder, has been approved for the reduction of allergic reactions in children aged four to 17. It is not an emergency treatment but instead designed to build tolerance.
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FDA approves first interactive digital inhaler sensor
The FDA has given its first approval to an interactive digital inhaler sensor that allows patients to manage their condition by providing instructions and recording usage data.
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FDA grants priority review to selpercatinib New Drug Application
Priority review has been given to the NDA for selpercatinib to treat advanced RET fusion-positive non-small cell lung cancer, RET-mutant medullary thyroid cancer and RET fusion-positive thyroid cancer.
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Five of the most recent pharma collaborations in 2020
As companies continue to collaborate and share their expertise to develop therapeutics targeting a wide range of diseases, European Pharmaceutical Review explores the aims of the most recent partnerships.
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FDA releases guidance on gene therapy manufacturing
In an effort to support innovation in the development of gene therapy products, the FDA has released guidance to provide regulatory clarity for product developers.
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FDA to promote development of coronavirus diagnostics and countermeasures
The US FDA has revealed its action plan to aid in the development and advancement of diagnostics and medical countermeasures to combat the novel coronavirus 2019.
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Spotlight: a dispersible tablet formulation to treat HIV in children
A novel formulation for dolutegravir has been developed to improve HIV treatment options for children. Dr Kimberly Smith from ViiV Healthcare discusses the benefits of this new dispersible tablet.
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FDA approves Tepezza for the treatment of thyroid eye in adults
The US FDA approved Tepezza (teprotumumab-trbw), the first treatment for thyroid eye, on the basis of two trials in which the drug improved eye protrusion in patients.
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Investigational New Drug application approved for LINCL treatment
The FDA has granted Investigational New Drug application to PLX-200 to treat late infantile neuronal ceroid lipofuscinosis (LINCL).
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Less than half of US clinical trials comply with reporting regulations
Researchers have found that only 41 percent of trials reported their findings with a year after completion and suggest that over $4 billion in fines could have been collected in just 12 months.
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Fast Track Designation granted to decompensated heart failure treatment
The US FDA has granted Fast Track Designation to APD418, which is in development as treatment for decompensated heart failure patients.
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FDA issues warning letter to Health Pharma for cGMP violations
An inspection at a manufacturing facility belonging to Health Pharma has revealed breaches of cGMP regulations, causing the FDA to send a warning letter.
