FDA issues complete response letter for DURECT’s anaesthetic drug Posidur
Based on the review, the FDA has determined that they cannot approve the new drug application (NDA) in its present form, stating the NDA does have sufficient information
Summit Therapeutics’ partner Akeso has secured China’s National Medical Products Administration (NMPA) authorisation for the use of ivonescimab in combination with chemotherapy as a first-line treatment for advanced squamous non-small cell lung cancer (NSCLC) patients.
Results of the study were recently published in Molecular Cancer Therapeutics. The study, led by Dr Arnon Nagler, director of the Hematology Division and Bone Marrow Transplantation Center
The product will be produced by Axxess Pharma’s wholly-owned subsidiary, AllStar Health Brands. Axxess Pharma president Dr Daniel Bagi noted the addition of Muscle Explosion expands the potential
Sprout will resubmit the New Drug Application (NDA) for flibanserin, a once-daily treatment for Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women, by the third quarter. The FDA