New Drug Application of Zydus’ Desidustat tablets by China Medical System Holdings accepted in China
Desidustat, administered orally is a novel, oral Hypoxia-Inducible Factor-Prolyl Hydroxylase Inhibitor (HIF-PHI) for treating…
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Browsing Tag
New Drug Application
US FDA accepts Sun Pharma’s NDA for Deuruxolitinib
Deuruxolitinib is being evaluated for treatment of moderate to severe alopecia areata
US FDA accepts New Drug Application for GSK’s momelotinib for treatment of myelofibrosis
Regulatory submission included data from the pivotal Momentum phase-III clinical trial that met all primary and key secondary…
US FDA approves Onureg (azacitidine tablets) to treat acute myeloid leukaemia
AML is one of the most common acute leukaemias in adults
Zydus Cadila files NDA for Saroglitazar Magnesium
NASH is a progressive disease of the liver and a significant unmet medical need. There are currently no treatments available for…
Alembic Pharma gets USFDA nod for ointment to treat various skin diseases
Alembic said it has a cumulative total of 104 abbreviated new drug application (ANDA) approvals from USFDA
USFDA issues response letter for new drug application for insulin glargine: Biocon
As per the USFDA, a Complete Response Letter (CRL) is sent to an applicant if the agency determines that it will not approve the…
US FDA reverses NDA nod for Sun Pharma’s anti epileptic drug
SPARC had earlier received a final approval from US FDA in March 2015 for this product Sun Pharma Advanced Research Company…