News about Regulation

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 |  474

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 |  248

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 |  313

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 |  292

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 |  329

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In a new draft guidance, the FDA proposes major updates to simplify biosimilarity studies and reduce unnecessary clinical testing.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 |  215

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 |  264

CDSCO lists 1,700 BIS standards to strengthen medical device compliance and hospital planning

The Central Drugs Standard Control Organisation (CDSCO) has released a comprehensive list of around 1,700 standards developed under the Medical Equipment and Hospital Planning Division (MHD) of the Bureau of Indian Standards (BIS).

Regulation | 28/10/2025 | By Darshana |  456

FDA Approves Genentech's Gazyva for Treatment of Lupus Nephritis

The US Food and Drug Administration (FDA) has approved Gazyva (obinutuzumab), developed by Genentech, for the treatment of adults with lupus nephritis (LN), also known as lupus-related kidney disease.

Regulation | 21/10/2025 | By Dineshwori |  196

Alembic Pharmaceuticals Gets USFDA Nod for Triamcinolone Acetonide Injection

The approved ANDA, Triamcinolone Acetonide Injection, is therapeutically equivalent to the Reference Listed Drug (RLD) product, Kenalog-40 Injectable Suspension, of Bristol-Myers Squibb company.

Regulation | 21/10/2025 | By Dineshwori |  291