Drug Approval | December 26, 2023
Wainua granted first-ever regulatory approval in the US for improving neuropathy impairment
US FDA approval based on NEURO-TTRansform Phase III results
US FDA approval based on NEURO-TTRansform Phase III results
Under the licensing agreement, Alkem will carry out the clinical development of “SON-080” in India with support from Sonnet and enable global and India regulatory filings
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) Neurontin Tablets, 600 mg and 800 mg, of Viatris Specialty
Submission based on positive results from global phase 3 study demonstrating overall survival benefit of TIVDAK over chemotherapy
The collaboration between CORONA and Ferring will cater to patients across India
Results showed a statistically significant and clinically meaningful improvement in investigator-assessed progression-free survival
The two generic drugs have been launched under the brand names Jankey & Sitenali.
The FDA informed Astellas that it did not have sufficient information to assess the risks to subjects
Novel delivery of established growth and neurotrophic factors enables local, sustained release for greater efficacy
Phase 2a clinical proof-of-concept biomarker study for PXL065 in ALD now anticipated to start midyear
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