Drug Approval | January 19, 2023
USFDA completes inspection at APL HealthCare
The company has been issued ‘Form 483’ with two observations
The company has been issued ‘Form 483’ with two observations
Through the new agreements, Cristal Therapeutics and McSAF will gain access to Lonza’s integrated bioconjugates offering and will be able to leverage Lonza’s expertise in developing and manufacturing bioconjugates
AI-based medical imaging equipment firm Lunit has signed a contract to supply AI-based breast cancer screening solution “Lunit Insight MMG”
India's G20 Presidency will focus on three main priorities: Health Emergencies Prevention, Preparedness and Response (One Health & AMR); Access and Availability to Affordable Medical Countermeasures (Vaccines, Therapeutics, and Diagnostics); and Digital Health
Dolutegravir and Rilpivirine Tablets, 50 mg/25 mg, (RLD Juluca) had estimated annual sales of US $666 million in the US (IQVIA MAT September 2022)
APAC to see a reduction in imported surgical robotics
The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad, India
The company will respond to these observations within the stipulated time period.
Brexpiprazole is an atypical antipsychotic indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults
Palbociclib has a unique mechanism of action which helps in delaying disease progression when co-administered with hormonal therapies
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