News | January 25, 2022
USFDA rejects Merck’s gefapixant; gain approval in Japan
Merck is studying the Complete Response Letter and it is not related to the safety of gefapixant
Merck is studying the Complete Response Letter and it is not related to the safety of gefapixant
Studies show significant reduction in pain and improved quality of life for patients treated with spinal cord stimulation compared to medication management alone
APS03118 is a novel innovative drug developed by APS with global independent intellectual property rights for unlimited cancer types
Pfizer is evaluating the FDA’s comments and will work with the agency to determine an appropriate path forward
Previously, the use of the drug was limited to patients requiring hospitalization
Go-ahead for pivotal clinical trial which is expected to commence by March
Phase 1/2 trial of E-602 expected to open in Q1 2022 in patients with solid tumours
First launches expected in H1 2022
It is the first monoclonal antibody drug for use in any animal species
This surpasses the number of approvals supported in 2020
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