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
The FDA grants ODD status to medicines and potential new medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US
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
Quviviq is a dual orexin receptor antagonist, which blocks the binding of the wake-promoting neuropeptides orexins and is thought to turn down overactive wakefulness, as opposed to treatments that generally sedate the brain
First launches expected in H1 2022
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