Indian pharmaceutical company Zydus has been granted approval by the USFDA to perform a Phase II(b) clinical trial aimed at identifying the ideal dosage strength of Usnoflast, an innovative oral NLRP3 inflammasome inhibitor for individuals with...
Alcresta Therapeutics, Inc., a prominent company in the commercial stage that specializes in creating and marketing innovative enzyme-based products, announced that the US Food and Drug Administration (FDA) has approved the expanded utilization of...
Eli Lilly and Company announced that the US Food and Drug Administration (FDA) has authorized Omvoh (mirikizumab-mrkz) for treating moderately to severely active Crohn's disease in adults. Omvoh has received approval in the US for two forms of...
Annovis Bio Inc., a company in the late stages of clinical drug development focused on innovative therapies for neurodegenerative disorders like Alzheimer’s disease (AD) and Parkinson’s disease (PD), revealed that it received the US patent for...
MedMira Inc. (MedMira) announced that it has secured approval from Health Canada for its Reveal Rapid G4 HIV-1/2 Test (Reveal HIV test) intended for Point-of-Care (POC) applications. The Reveal HIV rapid test boasts a sensitivity of 99.64% and a...
Alembic Pharmaceuticals Ltd announced that it has secured final approval from the US health regulator for its generic variant of Brexpiprazole tablets, which are used in treating major depressive disorder. The company announced that the US Food &...
The Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) from AstraZeneca and Daiichi Sankyo has been accepted and awarded Priority Review status in the US for treating adult patients with locally advanced or metastatic...
Roche announced that it has obtained 510(k) approval from the United States Food and Drug Administration (FDA) for its ultra-sensitive in-situ hybridisation (ISH) assay, the VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail. The assessment...
Cycle Pharmaceuticals, Inc. (Cycle) has announced the successful acquisition of Banner Life Sciences, LLC (Banner), which encompasses its BAFIERTAM® (monomethyl fumarate) product for treating relapsing forms of multiple sclerosis (MS) in adults...
Pharma lobby group Federation of Pharma Entrepreneurs (FOPE) has urged the government to extend the deadline for compliance with the revised Schedule M by two years. This comes as the government is nearing finalisation of a draft notification...
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