Vertex and CRISPR Therapeutics announce USFDA approval of Casgevy for treatment of sickle cell disease

Approximately 16,000 patients 12 years of age and older with severe sickle cell disease may now be eligible for this one-time treatment

Novartis receives FDA approval for Fabhalta as the first oral monotherapy for adults with PNH

Late-stage Fabhalta development program ongoing in multiple complement-mediated conditions

Zydus receives final approval from the USFDA for methylene blue injection

Methylene blue is a cationic thiazine dye that necessitates specialised capabilities and expertise to develop and manufacture the product

Lupin receives approval from U.S. FDA for Varenicline Tablets

Varenicline Tablets, 0.5 mg and 1 mg are indicated for use as an aid to smoking cessation treatment.

Indoco Remedies receives tentative ANDA approval from USFDA for Canagliflozin Tablets

This product will be manufactured by Indoco Remedies at their manufacturing facility located at Goa

Zydus receives final approval from the USFDA for Ivabradine Tablets

Ivabradine Tablets, 5 mg and 7.5 mg had annual sales of USD 136.5 mn in the United States

USFDA inspection at Alkem Laboratories API manufacturing facility located at Mandva

The company has received Form 483 with three observations

Eugia Pharma receives USFDA approval for Budesonide Inhalation Suspension

The product is expected to be launched in FY25

Aurobindo Pharma receives USFDA approval for Darunavir Tablets

BrainSpec receives FDA clearance to begin using AI-backed solution for non-invasive brain chemistry measurement

First-ever brain chemistry database will allow clinicians to quickly infer brain biomarker data to support the diagnostic process in conditions such as Alzheimer's Disease