Pharma News

The U.S. Food and Drug Administration, USFDA has delivered a strong criticism to Amneal Pharmaceuticals, issuing a warning letter on August 27, 2025, for serious infractions in manufacturing practices at its Gujarat facility.

World Health Organization, WHO has released updated editions of its Model Lists of Essential Medicines and Essential Medicines for Children, adding new treatments for various types of cancer and for diabetes with associated comorbidities such as obesity.

A toxic protein forms dynamic pores in the membranes of brain cells – and that may be the key to understanding how Parkinson’s disease develops. This is the conclusion of a new study from Aarhus University, where researchers have developed an advanced method to track molecular attacks in real time.

Glenmark Pharmaceuticals Ltd., a research-led, global pharmaceutical company, today announced the initiation of a multi-country (ex-China) Phase 3 Clinical Trial for Envafolimab, a novel subcutaneous PD-L1 inhibitor, in patients with resectable Stage III Non-Small Cell Lung Cancer (NSCLC) in the neoadjuvant/adjuvant setting.

Novartis has entered into an agreement to acquire Tourmaline Bio, Inc, a New York-based, publicly traded clinical-stage biopharmaceutical company focused on developing pacibekitug, an anti-IL-6 mAb, as a treatment option for atherosclerotic cardiovascular disease.

Sandoz has reached an agreement with Regeneron Pharmaceuticals, Inc., to resolve all patent disputes between the two companies relating to the US Food and Drug Administration FDA-approved Sandoz aflibercept biosimilar.

Caplin Steriles Limited has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Milrinone Lactate in 5% Dextrose Injection, 20 mg/100 mL (0.2 mg/mL) and 40 mg/200 mL (0.2 mg/mL) Single-dose Infusion Bags, a generic therapeutic equivalent version of the Reference Listed Drug (RLD) PRIMACOR in Dextrose 5%, by Sanofi Aventis US LLC.

Global pharma major Lupin Limited (Lupin) announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Risperidone for extended-release injectable suspension, 25 mg per vial, 37.5 mg per vial, and 50 mg per vial, Single-Dose Vials.

India is preparing to expand its pharmaceutical exports to Russia, Brazil, and the Netherlands, seeking to diversify its markets beyond the United States