Roche receives FDA approval for the first companion diagnostic to identify patients ultralow metastatic breast cancer

The PATHWAY HER2 (4B5) test, the first and only FDA approved companion diagnostic for assessing HER2-low status since 2022, is now also approved to aid in the assessment of HER2-ultralow status for metastatic breast cancer patients.

Granules strengthens ADHD portfolio with FDA approval for Lisdexamfetamine Dimesylate capsules

Lisdexamfetamine Dimesylate is indicated for the treatment of Attention Deficit Hyperactivity Disorder in adults and pediatric patients aged six years and older

Strides receives USFDA approval for Acetaminophen and Ibuprofen Tablets

The Acetaminophen and Ibuprofen tablets will be manufactured at the company’s flagship facility in KRSG, Bengaluru

Caplin Steriles gets USFDA approval for Levetiracetam in Sodium Chloride Injection Infusion bags

This is the second Ready-To-Use Infusion bag (RTU Bags) ANDA drug product approved for Caplin Steriles

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

Caplin Steriles gets USFDA approval for Difluprednate Ophthalmic emulsion

Difluprednate Ophthalmic Emulsion, 0.05% is a topical corticosteroid that is indicated in the treatment of inflammation and pain associated with ocular surgery

Granules India FDA approval for ADHD treatment

Eugia Pharma receives USFDA approval for Pazopanib Tablets, 200 mg

The approved product has an estimated market size of US$ 106 million for the twelve months ending October 2024, according to IQVIA

Shilpa Medicare’s JV Oncosol gets USFDA approval for IMKELDI

IMKELDI is an advanced liquid formulation of imatinib designed to provide dosing accuracy

Lupin receives USFDA approval for mixed salts of a single-entity amphetamine ER capsules

The product will be manufactured at Lupin’s Somerset facility in the US