News about Regulation

Biocon Pharma Receives US FDA Nod for Tofacitinib Extended-Release Tablets

Biocon Pharma has received approval from the US Food and Drug Administration (US FDA) for its ANDA for tofacitinib extended-release tablets, securing final approval for the 11 mg strength and tentative approval for the 22 mg strength.

Regulation | 19/11/2025 | By Dineshwori |  400

Lilly India Receives CDSCO Approval for Donanemab to Treat Early Alzheimer's Disease

Eli Lilly and Company (India) Pvt. Ltd. has received marketing authorization from the Central Drugs Standard Control Organization (CDSCO) for donanemab, a treatment for adults in the early symptomatic stages of Alzheimer’s disease.

Regulation | 18/11/2025 | By Darshana |  661

EMA Enhances Scientific Advice Process for Medicines Targeting Public Health Threats

Under the new system, medicine developers can receive joint scientific advice from EMA and national clinical and ethics experts. This coordinated approach aligns trial and regulatory requirements early, helping accelerate trial approvals and access to critical medicines.

Regulation | 18/11/2025 | By Dineshwori |  458

Zydus Lifesciences Secures US FDA Approval for Leuprolide Acetate Injection

Zydus Lifesciences has received final approval from the US Food and Drug Administration (FDA) for its generic version of Leuprolide Acetate injection, in a 14 mg/2.8 mL (1 mg/0.2 mL) multiple-dose vial format.

Regulation | 17/11/2025 | By Darshana |  408

IPC and Jharkhand Pharmacy Council Join Hands to Strengthen Drug Safety

The Indian Pharmacopoeia Commission (IPC) and the Jharkhand State Pharmacy Council (JSPC) have signed an MoU to improve medication safety and strengthen pharmacovigilance across the state.

Regulation | 16/11/2025 | By Darshana |  286

CHMP Recommends Sanofi's Tezeild for EU Approval in Stage 2 Type 1 Diabetes

The CHMP has backed EU approval for Sanofi’s Tezeild, supported by TN-10 study results showing the therapy can delay progression to stage 3 type 1 diabetes in patients with stage 2 disease. If authorised, Tezeild would become the first disease-modifying treatment for T1D in the EU.

Regulation | 15/11/2025 | By Dineshwori |  411

Alembic Pharmaceuticals Secures Multiple USFDA Approvals; Q2 Revenue Rises 16 Percent

Alembic Pharmaceuticals has announced a series of regulatory milestones, receiving final approval from the US Food & Drug Administration (USFDA) for four Abbreviated New Drug Applications (ANDAs) in the month.

Regulation | 15/11/2025 | By Dineshwori |  289

Zydus Lifesciences Receives USFDA Tentative Nod for Generic Multiple Sclerosis Drug

Zydus Lifesciences has received tentative approval from the United States Food and Drug Administration (USFDA) for Diroximel Fumarate delayed-release capsules, 231 mg, a generic version of Vumerity delayed-release capsules of the same strength.

Regulation | 13/11/2025 | By Dineshwori |  514

Granules Life Sciences Secures First US FDA Approval for Metformin HCl Tablets

Granules Life Sciences Private Limited, a wholly owned subsidiary of Granules India Limited, has obtained its first approval from the US Food and Drug Administration (US FDA) for Metformin HCl tablets.

Regulation | 12/11/2025 | By Darshana |  415

Biocon's API Facility in Visakhapatnam Receives Two Observations from the US FDA

Indian biopharmaceutical company Biocon Ltd disclosed that its active pharmaceutical ingredient (API) manufacturing site in Visakhapatnam, Andhra Pradesh, was issued two observations following a routine US Food and Drug Administration (FDA) inspection.

Regulation | 11/11/2025 | By Darshana |  541