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2818 News Found

USFDA accepts for review the biologics license application for Pfizer’s Investigational MenABCWY in adolescents
Drug Approval | December 31, 2022

USFDA accepts for review the biologics license application for Pfizer’s Investigational MenABCWY in adolescents

If approved, the vaccine could help simplify the meningococcal vaccination schedule and provide the broadest serogroup coverage of any meningococcal vaccine


MindRank gets USFDA clearance of IND application for MDR-001 for treatment of Type 2 diabetes
Drug Approval | December 27, 2022

MindRank gets USFDA clearance of IND application for MDR-001 for treatment of Type 2 diabetes

MindRank expects to initiate a Phase I safety study in the first quarter of 2023.


Healthium divests its UK based continence care organization Clinisupplies
News | December 07, 2022

Healthium divests its UK based continence care organization Clinisupplies

Proceeds from the transaction will be reinvested towards the growth, innovation and expansion of Healthium’s advanced surgery, orthopaedics, wound care and post-surgical care portfolio


EMA accepts marketing authorisation application for momelotinib for the treatment of myelofibrosis
News | December 05, 2022

EMA accepts marketing authorisation application for momelotinib for the treatment of myelofibrosis

Application includes data from key phase III trials, including the pivotal MOMENTUM trial, which met all primary and key secondary efficacy endpoints


YS Biopharma announces USFDA clearance of IND Application for PIKA COVID-19 vaccine
Drug Approval | November 11, 2022

YS Biopharma announces USFDA clearance of IND Application for PIKA COVID-19 vaccine

PIKA COVID-19 vaccine is currently in Phase 3, multi-country, multi-center clinical trial conducted at Southeast Asian and Middle East countries.


USFDA Issues a CRL for the Biologics License Application for Insulin Aspart
Drug Approval | October 27, 2022

USFDA Issues a CRL for the Biologics License Application for Insulin Aspart

The CRL did not identify any outstanding scientific issues with the product.


Pfizer announces positive topline results from Phase 3 TALAPRO-2 trial
Diagnostic Center | October 09, 2022

Pfizer announces positive topline results from Phase 3 TALAPRO-2 trial

Study achieves primary endpoint of radiographic progression-free survival


BioMarin simplifies organizational structure to increase efficiency
News | October 09, 2022

BioMarin simplifies organizational structure to increase efficiency

The reduction in force will result in financial savings of approximately $50 million annually beginning in 2023


Pfizer and BioNTech submit application to USFDA for emergency use authorization of Omicron BA.4/BA.5-adapted bivalent vaccine booster for 5-11 year age
Drug Approval | September 27, 2022

Pfizer and BioNTech submit application to USFDA for emergency use authorization of Omicron BA.4/BA.5-adapted bivalent vaccine booster for 5-11 year age

The companies have also initiated a Phase 1/2/3 study NCT05543616 to evaluate the safety, tolerability, and immunogenicity of different doses