FDA

Mitapivat Granted Priority Review By The FDA For Pyruvate Kinase (PK) Deficiency
Clinical News

Mitapivat Granted Priority Review By The FDA For Pyruvate Kinase (PK) Deficiency

The U.S. Food and Drug Administration (FDA) has accepted Agios’ New Drug Application (NDA) for Mitapivat for the treatment of adults with pyruvate kinase (PK) deficiency. The NDA was granted…
CDC, FDA Authorize Third Dose Of COVID-19 Vaccines For The Immunocompromised In The US
Clinical News

CDC, FDA Authorize Third Dose Of COVID-19 Vaccines For The Immunocompromised In The US

The U.S. Food and Drug Administration (FDA) and the U.S. Centers for Disease Control and Prevention (CDC)  have both recommended on August 16 that certain immunocompromised people receive a third…
Global Blood Submits US Application For Expanded Use Of SCD Drug, Oxbryta, In Patients Aged 4-11 Years
Clinical News

Global Blood Submits US Application For Expanded Use Of SCD Drug, Oxbryta, In Patients Aged 4-11 Years

Children with sickle cell disease (SCD) as young as age 4 could be prescribed Oxbryta (Voxelotor) if the U.S. Food and Drug Administration (FDA) approves a supplemental new drug application (sNDA) submitted by…
Imara Announces First Patient Dosed in Forte Phase 2b Clinical Trial of IMR-687 in β-Thalassaemia
Clinical News

Imara Announces First Patient Dosed in Forte Phase 2b Clinical Trial of IMR-687 in β-Thalassaemia

Imara Inc., a clinical-stage biopharmaceutical company dedicated to developing and commercializing novel therapeutics to treat patients suffering from rare inherited genetic disorders of haemoglobin,  announced dosing of the first patient…
IMR-687 Receives FDA Fast Track & Rare Pediatric Disease Designations for the Treatment of β-Τhalassaemia
Clinical News

IMR-687 Receives FDA Fast Track & Rare Pediatric Disease Designations for the Treatment of β-Τhalassaemia

IMARA Inc., a clinical-stage biopharmaceutical company dedicated to developing and commercializing novel therapeutics to treat patients suffering from rare inherited genetic disorders of haemoglobin, announced the U.S. Food and Drug…
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