News about Regulation

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 |  120

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 |  176

Ascelia Pharma Strengthens Market Protection for Orviglance with New Patent Filing

Sweden-based biotech company Ascelia Pharma has filed a new patent application for its first-in-class orphan liver imaging drug, Orviglance.

Regulation | 10/11/2025 | By Dineshwori

Alembic Pharmaceuticals Receives USFDA Approval for Generic Dasatinib Tablets

Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dasatinib Tablets in strengths of 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg.

Regulation | 07/11/2025 | By Dineshwori |  255

Jaya Biosciences Receives US Patent for Novel Methods of Treating Neurological Diseases

US patent grant to Jaya Biosciences broadens protection and strengthens the company’s leadership in developing CNS-directed therapies for genetically defined neurodegenerative diseases.

Regulation | 07/11/2025 | By Dineshwori |  111

FDA Approves Johnson & Johnson's DARZALEX FASPRO for Treatment of High-Risk Smoldering Multiple Myeloma

DARZALEX FASPRO is the first and only approved treatment for high-risk smoldering multiple myeloma, according to Johnson & Johnson.

Regulation | 07/11/2025 | By Dineshwori |  145

Zydus Gets USFDA Tentative Nod for Budesonide Delayed-Release Capsules, 4 mg

Zydus has received tentative approval from the US Food and Drug Administration (USFDA) for its Budesonide delayed-release capsules, 4 mg. The drug is indicated for the treatment of mild to moderate active Crohn’s disease affecting the ileum and/or ascending colon in adults and children aged eight years and above.

Regulation | 05/11/2025 | By Dineshwori |  128

UCB Wins FDA Approval for KYGEVVI, First-Ever Treatment for Thymidine Kinase 2 Deficiency

UCB, the Brussels-based multinational biopharmaceutical company, has received approval from the US Food and Drug Administration (FDA) for KYGEVVI (doxecitine and doxribtimine), marking the first and only approved treatment for thymidine kinase 2 deficiency (TK2d) in adults and pediatric patients whose symptoms began at or before 12 years of age.

Regulation | 04/11/2025 | By Dineshwori |  187

FDA Moves to Accelerate Biosimilar Development and Lower Drug Costs

In a new draft guidance, the FDA proposes major updates to simplify biosimilarity studies and reduce unnecessary clinical testing. The agency, through a separate initiative, also plans to make it easier for biosimilars to be developed as interchangeable with brand-name biologics, helping patients and pharmacists choose lower-cost options more easily.

Regulation | 01/11/2025 | By Dineshwori |  111

Alembic Pharmaceuticals Secures USFDA Approval for Ticagrelor Tablets, 60 mg

Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ticagrelor Tablets, 60 mg. The product is therapeutically equivalent to Brilinta Tablets, 60 mg, from AstraZeneca.

Regulation | 29/10/2025 | By Dineshwori |  132