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mRNA-1273.222 has also received FDA EUA for children and adolescents between six and 17 years of age and for adults over the age of 18 years of age. 


Moderna Receives FDA Emergency Use Authorization for Omicron-Targeting Bivalent COVID-19 Booster Vaccine in Children 

The guidance discusses statistical approaches for BE comparisons and focuses on how to use these approaches both generally and in specific situations. 

FDA Publishes Draft Guidance on Statistical Approaches to Establishing Bioequivalence

Lonza’s investment in its Stein and Basel facilities in Switzerland aims to expand its overall drug product development and manufacturing services.

Lonza to Expand Capabilities at Manufacturing Sites in Switzerland

USAntibiotics will serve as the sole American-based provider of amoxicillin and amoxil clavulanate.

USAntibiotics Reopens Facility, Returning Antibiotic Production to the United States

Syngene’s additions include a new microbial facility and an expanded mammalian facility.

Syngene Expands Microbial and Mammalian Manufacturing Facilities in Bengalaru

Recro acquires CDMO IRISYS, establishing a bi-coastal presence in the US.

Recro Acquires IRISYS for $50 Million

Veraxa and Indivumed will work together to develop colorectal antibody drugs.

Veraxa and Indivumed Collaborate on Development of Precision Oncology Antibody Drugs

Syngene International appoints two US-based executives to senior level positions.

Syngene Announces Senior Level Appointments

VICO Therapeutics’ drug candidate, VO659, for treating Huntington’s Disease was granted orphan drug designation by FDA. 

FDA Grants Orphan Drug Designation to VICO Therapeutics for Huntington’s Disease Drug 

Kriya Therapeutics completes $100 Million Series B financing to advance its platform for designing, developing, and manufacturing gene therapies. 

Manufacturing, Drug Products