Drug Approval | February 10, 2022
USFDA awards QIDP designation for prevention of chlamydia to Evofem Biosciences
Adds five years of market exclusivity on approval
Adds five years of market exclusivity on approval
The FDA grants ODD status to medicines and potential new medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US
BPZE1 is the most advanced next-generation pertussis vaccine currently in clinical development
Alzheimer's disease is a serious, progressive and devastating disease with few treatment options
ZY19489 is a novel anti-malarial compound active against all current clinical strains of P. falciparum and P. vivax, including drug resistant strains
GCC Biotech is manufacturing the kits on a public-private partnership (PPP) model
Theradaptive's regenerative implants are best-in-class and are designed to permit precise tissue regeneration for a variety of tissue types and clinical indications
It is the first blood test able to detect early-stage Breast Cancer with high accuracy in women above the age of 40 years
Tezepelumab has been granted Orphan Drug Designation (ODD) in the US by the U.S. Food and Drug Administration (FDA) for the treatment of eosinophilic esophagitis (EoE)
Gantenerumab is an investigational antibody in Phase III development for early Alzheimer's disease (AD) and a comprehensive data set with an expected readout in mid-2022
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