Chantal van Gils joins NDA Advisory Board as Director of Epidemiology
She will provide strategic advice and scientific leadership to support clients in clinical development, registration strategy, submission, early post-approval strategy
She will provide strategic advice and scientific leadership to support clients in clinical development, registration strategy, submission, early post-approval strategy
The only definitive way to diagnose and stage lung cancers is through biopsies
Total investment envisaged in this project stands at up to Rs 70 crore
The receipt of this permission paves way for the launch of Dapagliflozin (Forxiga) tablets of 10 mg in India for the specified additional/expanded indication, subject to the receipt of related statutory approvals
The two have agreed to jointly undertake R&D activities on scientific validation of Ayush concepts, procedures and products
The inspection of the facility resulted in issuance of a Form-483 with eight observations each for the Drug Product facility and API facility at the site
Famotidine Injection is indicated to treat ulcers of the stomach and intestines and to prevent intestinal ulcers from coming back after they have healed
Ryzneuta is a novel dimeric G- CSF long-acting fusion protein without pegylation. The Biologics License Application (BLA) of Ryzneuta is currently under late-stage review by the US FDA for Chemotherapy-Induced Neutropenia (CIN)
He brings over 30 years of experience across various organizations such as Asian Paints PPG, Berger Paints, Tata Steel, among others
The company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility
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