Granules has undertaken a proactive, voluntary and comprehensive remediation plan to address the six form 483 observations raised by the USFDA
The first and only immuno-oncology drug approved for the treatment of nasopharyngeal carcinoma
WINREVAIR met primary endpoint of time to first morbidity or mortality event for the treatment of patients with pulmonary arterial hypertension (PAH) functional class III or IV at high risk of mortality
This is recommended for in-ovo vaccination of 18 to 19-day-old embryonated chicken eggs and one-day old chickens to protect against the virulent Marek’s disease
Bringing a new drug to market takes about 10 years and requires an investment of approximately $1 billion
HYMPAVZI’s approval is based on Phase 3 study results demonstrating non-inferiority and superiority compared to routine prophylaxis in eligible patients with hemophilia A or B without inhibitors
Statistically significant and clinically meaningful reduction in the risk of death seen with Blenrep (belantamab mafodotin) plus bortezomib and dexamethasone (BorDex) versus daratumumab plus BorDex
Real-world and long-term extension data, including updated results from post-launch evaluation of REMS Program, bolster growing body of evidence supporting the efficacy and safety profile of CAMZYOS
He specializes in financial planning, audit, compliance and ERP implementation, with extensive experience in leading automation and risk management projects
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