23 мая 2024 г. · The Medicines and Healthcare products Regulatory Agency approved gefapixant in December 2023 and it has been available in several countries, ...

The Medicines and Healthcare Products Regulatory Agency (MHRA) can confirm that no marketing authorisation has been granted for gefapixant.

30 нояб. 2023 г. · The FDA has not officially ruled on gefapixant but is expected to do so by Dec. 27. In explaining why GSK is “more confident” in camlipixant ...

21 дек. 2023 г. · Gefapixant was approved in Japan in 2022 for adults with refractory or unexplained chronic cough, where it is marketed as Lyfnua. The drug was ...

20 дек. 2023 г. · December 20, 2023 4:30 pm ET. RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, ...

21 дек. 2023 г. · The FDA has issued a complete response letter declining to approve a new drug application for gefapixant as a treatment for adults with ...

21 дек. 2023 г. · Merck first tried for an FDA approval in 2021 but was ultimately rejected in January 2022. Despite the regulatory speedbump, Merck said at the ...

5 окт. 2022 г. · Lung doctor says gefapixant could be first new treatment for condition to be approved in UK for more than 50 years.

21 июл. 2023 г. · MSD Receives Positive European Union CHMP Opinion for Gefapixant ... The CHMP's recommendation will now be reviewed by the European Commission (EC) ...

Although gefapixant is not yet approved by the FDA for use in the US, there remains a possibility that gefapixant could become the first licensed treatment for ...