News about Regulation

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 |  423

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 |  573

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 |  460

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 |  431

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 |  466

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 |  666

Biocon and Carnegie Secure Tentative FDA Approval for Rifaximin Tablets

Biocon Pharma, a wholly owned subsidiary of Biocon Ltd., in partnership with Carnegie Pharmaceuticals, has received tentative approval from the US Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Rifaximin Tablets, 550 mg.

Regulation | 07/10/2025 | By Dineshwori |  595

Zydus Receives USFDA Approval for Deflazacort Oral Suspension

Zydus stated that deflazacort oral suspension will be produced at Doppel, Italy.

Regulation | 06/10/2025 | By Dineshwori |  229

FDA Announces New ANDA Prioritisation Pilot to Support US Generic Drug Manufacturing and Testing

More than half of pharmaceuticals distributed in the US are manufactured overseas. Further, the US is reliant on overseas sources for Active Pharmaceutical Ingredients (APIs). As of 2025, only nine percent of API manufacturers are in the US, compared to 22 percent in China and 44 percent in India.

Regulation | 06/10/2025 | By Dineshwori |  250

Sitryx receives FDA clearance of IND application for SYX-5219 for the treatment of atopic dermatitis

Sitryx’s SYX-5219 is a first-in-class, oral, disease-modifying, anti-inflammatory therapy, targeting pyruvate kinase M2 (PKM2), a critical enzyme that regulates cell metabolism.

Regulation | 04/10/2025 | By Dineshwori |  404