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.
The CRL did not identify any outstanding scientific issues with the product.
Submission based on QuANTUM-First results showing quizartinib plus chemotherapy significantly improved overall survival compared to chemotherapy alone
68% of children on a higher dose of Dupixent achieved histological disease remission at week 16
Acquisition brings leading sickle cell disease portfolio and pipeline to Pfizer with potential to address critical needs in an underserved patient community
The companies have also initiated a Phase 1/2/3 study NCT05543616 to evaluate the safety, tolerability, and immunogenicity of different doses
Sitagliptin is an active ingredient in JANUVIA, JANUMET and JANUMET XR
NULIBRY is a first-in-class cPMP substrate replacement therapy to reduce the risk of mortality in patients with MoCD Type A.
Phase 2 study evaluating an investigational weekly oral combination treatment regimen of islatravir and Gilead Sciences’ lenacapavir to resume with lower dose of islatravir
New data from Boehringer Ingelheim support the potential use of nintedanib in children and adolescents with fibrosing interstitial lung disease
CHMP recommendation based on safety, tolerability, and immunogenicity data from a Phase 2/3 trial of the Omicron BA.1-adapted bivalent vaccine
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