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News about Regulation
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 | 305
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 | 384
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 | 353
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 | 368
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In a new draft guidance, the FDA proposes major updates to simplify biosimilarity studies and reduce unnecessary clinical testing.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 | 277
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 | 328
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 | 535
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 | 222
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 | 370
FDA Expands Indications for Celltrion's YUFLYMA to Include Pediatric and Adolescent Patients
Celltrion has announced that the US Food and Drug Administration (FDA) has approved expanded indications for YUFLYMA (adalimumab-aaty) and its unbranded version to include the treatment of hidradenitis suppurativa (HS) in adolescent patients aged 12 years and older, and uveitis (UV) in pediatric patients aged 2 years and older.
Regulation | 17/10/2025 | By Dineshwori | 470
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