F2G receives Complete Response Letter for olorofim NDA
The NDA was accepted by the regulatory agency for review with a PDUFA target action date set for 17 June 2023. As per the CRL, the regulatory body
The US Food and Drug Administration (FDA) has expanded the approved indication for Bristol Myers Squibb’s (BMS) Camzyos (mavacamten) to treat symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in adults and paediatric patients weighing at least 30kg (66lb).