Zydus and Synthon ink licensing and supply agreement for Ozanimod Capsules for US market

Under the terms of this agreement, Synthon will be responsible for obtaining final regulatory approval for its Ozanimod Capsules product

FDA completes inspection at Biocon Biologics' facility in Bengaluru

The U.S. FDA issued a Form 483 with five observations

Caplin Steriles granted final approval for ANDA Milrinone Lactate in 5% Dextrose Injection by USFDA

Milrinone is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure

Novartis Leqvio demonstrates strong LDL-C goal achievement with reduced muscle pain

The trial is the largest to date evaluating Leqvio and the first to focus on patient-centered outcomes

FDA approves Sanofi’s BTK inhibitor for immune thrombocytopenia

ITP is a disease of complex immune dysregulation leading to low platelet counts, bleeding, and reduced quality of life

Glenmark Pharmaceuticals USA to launch Eribulin Mesylate injection

Glenmark’s Eribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL) Single-Dose Vials is bioequivalent and therapeutically equivalent to the reference listed drug, Halaven Injection, 1 mg/2 mL (0.5 mg/mL),of Eisai

Shukra Pharmaceuticals bags Rs. 24 crore medicines supply contract from HSCC India

Zydus Wellness acquires U.K. based Comfort Click for Rs. 2,846 Cr

Enters the high growth vitamins, minerals and supplements segment for adults, paediatrics, and animal health

GEA, JGC commission new spray dryer at Chugai Pharmaceutical in Japan

This PSD-3, the first pharmaceutical spray dryer built by GEA for OEB-5 products, sets new standards for high-containment pharmaceutical spray drying

Apitoria Pharma receives 5 observations from USFDA for API facility

At the end of the current inspection, a 'Form 483' was issued with 5 observations which are procedural in nature and no data integrity issues were reported