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 ...

20 дек. 2023 г. · In the CRL, the FDA concluded that Merck's application did not meet substantial evidence of effectiveness for treating RCC and UCC. The CRL was ...

21 дек. 2023 г. · For the second time in nearly two years, Merck has failed to secure regulatory approval for its chronic cough drug gefapixant.

21 дек. 2023 г. · According to the FDA letter, the application failed to meet substantial evidence of effectiveness for the treatment of RCC and UCC. The CRL did ...

21 дек. 2023 г. · The FDA's decision was not related to the drug's safety, Merck said, adding that it is reviewing the agency's feedback to determine next steps.

19 мар. 2024 г. · In November 2023, Merck's chronic cough drug, gefapixant, faced a decisive setback from the FDA Advisory Committee. · Building a Stronger Case ...

17 нояб. 2023 г. · Gefapixant under the brand name LYFNUA, has been approved in Japan, Switzerland, and the European Union for treatment of adults with ...

16 нояб. 2023 г. · Ahead of tomorrow's advisory committee meeting, the FDA has shared doubts about Merck's gefapixant, a drug designed to treat chronic cough.

17 нояб. 2023 г. · In a 12-to-1 vote, the FDA's Pulmonary-Allergy Drug Advisory Committee voted against approving gefapixant 45 mg tablets to treat adults with ...