Merck is reviewing the FDA's feedback to determine the next steps. In January 2022, the FDA issued a CRL for the gefapixant application and requested additional information related to efficacy ...
However, Merck defended its drug, insisting that the data demonstrated significant clinical benefits for adults with refractory or unexplained chronic cough. The panel's vote could delay the ...
Merck filed for approval of gefapixant in March 2021 on the strength of a pair of phase 3 trials – COUGH-1 and COUGH-2 – which found that the drug reduced 24-hour cough frequency by 18% and 15 ...
It's worth noting that the agreement has been forged a few months after Merck suffered a setback in its attempt to secure FDA approval for a potentially first-in-class drug for chronic cough ...
Roche’s chronic cough program has sputtered to a halt ... Roche’s decision eliminates a cough candidate that was differentiated from Merck & Co.’s once-rejected gefapixant and GSK’s ...
The following is a summary of “Efficacy and safety of gefapixant in women with chronic cough and cough-induced stress urinary ...
Background: Children presenting with chronic cough are common to the primary care physicians, but data on the etiology are scant. Methods: We evaluated 40 children (age range, 5 to 12 years ...
Coughing can be a sign of a cold, the flu, allergies, asthma, gastroesophageal reflux disease (GERD), and chronic obstructive pulmonary disease (COPD). An acute cough that develops due to a ...
The toxin strychnine, the primary component of the traditional Chinese medicine, may act in the STAT3 pathway, investigators ...
It falls between an acute cough, which lasts less than 3 weeks, and a chronic cough, which lasts more than 8 weeks. There are various causes for a subacute cough, including infections, viruses ...
Merck Research Laboratories. "These approvals underscore the continued expansion of the use of KEYTRUDA in diverse patient populations and treatment settings with utility of KEYTRUDA ranging from ...