News about Regulation

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In a new draft guidance, the FDA proposes major updates to simplify biosimilarity studies and reduce unnecessary clinical testing.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.
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Regulation | 01/11/2025 | By Dineshwori

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

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

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

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

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 |  196

After India, Innocan Pharma Secures Patent Allowance in Japan for Liposomal CBD Delivery Platform

Israel-based pharmaceutical technology company Innocan Pharma Corporation has announced that its patent for the liposomal delivery platform LPT-CBD has been allowed in Japan and will be officially granted following the completion of administrative process.

Regulation | 16/10/2025 | By Dineshwori

Marksans Pharma's UK subsidiary Relonchem Secures MHRA Approval for Clonidine Tablets

Marksans Pharma’s wholly owned UK subsidiary, Relonchem, has received marketing authorisation from the UK Medicines & Healthcare products Regulatory Agency (MHRA) for Clonidine 100 microgram tablets and Clonidine Hydrochloride 25 microgram tablets.

Regulation | 15/10/2025 | By Dineshwori

Celltrion Receives US FDA Approval for EYLEA Biosimilar EYDENZELT

Celltrion has received approval from the US Food and Drug Administration (FDA) for EYDENZELT (aflibercept-boav), a biosimilar to EYLEA (aflibercept), for the treatment of neovascular (wet) age-related macular degeneration (wAMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR).

Regulation | 11/10/2025 | By Dineshwori |  134

WHO Prequalifies Shanchol Oral Cholera Vaccine

Shanchol remains the only oral cholera vaccine manufactured in India with WHO prequalification, underscoring India’s critical role in ensuring continuity of global supply.

Regulation | 07/10/2025 | By Dineshwori |  186