India’s Glenmark begins Covid-19 trials with antiviral tablet Favipiravir
The company has secured approval from the Drugs Controller General of India (DCGI) to begin the trial with Favipiravir at the end of April. Favipiravir is a generic
Axsome Therapeutics has received the US Food and Drug Administration (FDA) approval for Auvelity (dextromethorphan HBr and bupropion HCl) to treat agitation associated with dementia due to Alzheimer’s.
Enhertu, a HER2-directed antibody drug conjugate (ADC), is being studied under a comprehensive development programme to assess the efficacy and safety of the monotherapy across multiple HER2-driven cancers
Trastuzumab deruxtecan has previously received SAKIGAKE designation for this second potential indication and will receive an expedited review time of six months. Currently, there are no HER2 directed
Certara will support the DMTC-led clinical trial by analyzing study data to develop mathematical models to understand the viral time course and factors impacting drug exposure and prophylactic