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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


SVU to organise International Conference on Clinical Translation of Biomaterial-based Therapeutics and Devices on 6-7 Feb, 2025
News | December 26, 2024

SVU to organise International Conference on Clinical Translation of Biomaterial-based Therapeutics and Devices on 6-7 Feb, 2025

The technical program will run in four sessions and a panel discussion on “Challenges in translation of medical technologies”


Alembic Pharmaceuticals receives USFDA final approval for Divalproex Sodium Delayed-Release Capsules
Drug Approval | December 22, 2024

Alembic Pharmaceuticals receives USFDA final approval for Divalproex Sodium Delayed-Release Capsules

Divalproex Sodium Delayed-Release Capsules USP, 125 mg have an estimated market size of US$ 61.1 million for twelve months ending September 2024 according to IQVIA


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


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


Lonza expands capsule manufacturing capacity in India and China
News | December 21, 2024

Lonza expands capsule manufacturing capacity in India and China

New capsule manufacturing lines added at Lonza Capsules & Health Ingredients (CHI) facilities in Rewari and Suzhou


USFDA approves Encorafenib plus Cetuximab and Chemo in BRAF V600E-positive mCRC
Drug Approval | December 21, 2024

USFDA approves Encorafenib plus Cetuximab and Chemo in BRAF V600E-positive mCRC

Accelerated approval is based on 61% overall response rate compared to 40% in control arm in the


Zydus receives final approval from USFDA for Lidocaine and Prilocaine Cream USP
Drug Approval | December 20, 2024

Zydus receives final approval from USFDA for Lidocaine and Prilocaine Cream USP

Lidocaine and Prilocaine cream had annual sales of US $22.05 million in the United States (IQVIA MAT October 2024)