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2759 News Found

FDA approves Pfizer's supplemental new drug application for CIBINQO
Drug Approval | February 14, 2023

FDA approves Pfizer's supplemental new drug application for CIBINQO

Label expansion for CIBINQO provides new systemic oral option for adolescents (12 to <18 years) with moderate-to-severe atopic dermatitis


ExeGi Pharma gets clearance of IND application for EXE-346 a Live biotherapeutic biologic drug
Drug Approval | January 30, 2023

ExeGi Pharma gets clearance of IND application for EXE-346 a Live biotherapeutic biologic drug

This clearance allows the company to initiate a clinical trial for patients with an ileal pouch-anal anastomosis


US FDA accepts supplemental new drug application for Jardiance for adults with chronic kidney disease
News | January 23, 2023

US FDA accepts supplemental new drug application for Jardiance for adults with chronic kidney disease

The supplemental New Drug Application is based on results from the landmark EMPA-KIDNEY phase III trial


H.B. Fuller to launch new bio-compatible adhesive for medical applications
News | January 12, 2023

H.B. Fuller to launch new bio-compatible adhesive for medical applications

Swiftmelt 1515-I meets performance requirements and secures skin attachment


Applied Therapeutics partners with Advanz Pharma for commercialization of Govorestat in Europe
Biotech | January 05, 2023

Applied Therapeutics partners with Advanz Pharma for commercialization of Govorestat in Europe

Advanz Pharma will leverage its specialty, hospital, and rare disease expertise and infrastructure to commercialize AT-007 in Europe for both Galactosemia and SORD Deficiency


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