FDA grants Priority Review to capmatinib – a targeted lung cancer therapeutic
The US Food and Drug Administration (FDA) has granted Priority Review for capmatinib, a treatment for MET exon 14 skipping mutated non-small cell lung cancer.
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The US Food and Drug Administration (FDA) has granted Priority Review for capmatinib, a treatment for MET exon 14 skipping mutated non-small cell lung cancer.
Researchers at Aston University and Birmingham Children’s Hospital, UK, have discovered a highly effective three-drug approach to treat Mycobacterium abscessus (M. abscessus), a notoriously drug-resistant pathogen that affects up to 13 percent of cystic fibrosis (CF) patients in the UK.
The two agencies have signed a statement of their intent to combat anti-competitive practices which are preventing the adoption of biosimilars in the US drug market.
New research has suggested that the expiration of biologics patents will be the factor that positively impacts US pharma the most this year.
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.
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.
Rompe Pecho EX, Rompe Pecho CF and Rompe Pecho MAXliquid are being recalled due to microbial contamination.
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.
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.
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.
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.
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.
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.
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.
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.