Alembic announces USFDA final approval for Dasatinib Tablets

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Sprycel Tablets

FDA approves Alembic's Ticagrelor Tablets, 60 mg

Ticagrelor tablets are indicated for reducing the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients

Caplin Steriles receives FDA approval for ANDA Nicardipine Hydrochloride in 0.9% Sodium Chloride injection

Nicardipine Hydrochloride in 0.9% Sodium Chloride Injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible or desirable

FDA approves Alembic’s Triamcinolone Acetonide injectable suspension USP, 40 mg/mL

Triamcinolone Acetonide injectable suspension USP is indicated for various autoimmune, inflammatory, and other conditions

Merck’s DOR/ISL regimen shows minimal impact on weight and lipids in phase 3 HIV studies

These findings follow positive Phase 3 results presented earlier this year

FDA approves AbbVie’s Upadacitinib for treatment of inflammatory bowel disease

Updated indication expands treatment options for patients with ulcerative colitis and Crohn’s disease when tumor necrosis factor (TNF) blockers are clinically inadvisable

FDA supports new ANDA prioritization pilot to support US generic drugs

TAHO Pharma submits NDA to FDA for world’s first Apixaban oral dissolving film

Pioneering innovation aims to transform anticoagulant therapy and improve patient outcomes

Wockhardt submits NDA to USFDA for Zidebactam-Cefepime injection

The NDA submission follows the successful completion of a pivotal Phase III global clinical trial

FDA issues CRL for Sentynl’s copper histidinate for treatment of Menkes disease