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1903 News Found

Sumitomo Pharma America receives USFDA approval of vibegron for benign prostatic hyperplasia
Drug Approval | December 27, 2024

Sumitomo Pharma America receives USFDA approval of vibegron for benign prostatic hyperplasia

GEMTESA is the first and only beta-3 agonist approved for the treatment of men with OAB symptoms who are receiving pharmacological therapy for BPH


Kwality Pharmaceuticals receives approval for Tamoxifen 20mg Tablet in South Africa
News | December 26, 2024

Kwality Pharmaceuticals receives approval for Tamoxifen 20mg Tablet in South Africa

This approval is a significant achievement in expanding the availability of this critical therapeutic,


Aarti Drugs receives EIR from USFDA for Tarapur API facility
Drug Approval | December 26, 2024

Aarti Drugs receives EIR from USFDA for Tarapur API facility

This facility is considered to be in a minimally acceptable state of compliance with regard to current GMP


CuraTeQ Biologics receives approval for oncology biosimilar Bevqolva from UK's MHRA
News | December 22, 2024

CuraTeQ Biologics receives approval for oncology biosimilar Bevqolva from UK's MHRA

Bevqolva 25 mg/mL concentrate for infusion will be available in 4 mL (100 mg) and 16 mL (400 mg) single-use vials for infusion into veins


Briefs: Gandhar Oil Refinery India, FDC and Apitoria Pharma
Drug Approval | December 22, 2024

Briefs: Gandhar Oil Refinery India, FDC and Apitoria Pharma

FDC Ltd has received final approval from USFDA for the company's Abbreviated New Drug Application (ANDA) for Cefixime 400 mg Tablets


Zaynich enables US cancer patient undergo successful liver transplant and resume chemotherapy
News | December 17, 2024

Zaynich enables US cancer patient undergo successful liver transplant and resume chemotherapy

In the US, the compassionate use approvals are provided by FDA in the form of individual patient-specific expanded-access IND


Granules India FDA approval for ADHD treatment
Drug Approval | December 17, 2024

Granules India FDA approval for ADHD treatment


Bayer announces positive topline resukts for Aflibercept 8 mg in phase III study
Clinical Trials | December 17, 2024

Bayer announces positive topline resukts for Aflibercept 8 mg in phase III study

Demonstrates vision gains with extended treatment intervals in retinal vein occlusion


Merck announces FDA acceptance of biologics license application for Clesrovimab
Drug Approval | December 17, 2024

Merck announces FDA acceptance of biologics license application for Clesrovimab

An investigational long-acting monoclonal antibody designed to protect infants from RSV disease during their first RSV season