News about Regulation

Chugai Announces Discontinuation of Emugrobart Trials in SMA and FSHD

Roche halts development after mid-stage trials fail to show consistent functional benefits, while obesity-focused trials continue amid promising scientific rationale.

Regulation | 25/03/2026 | By News Bureau |  155

Ipsen Discontinues Tazverik for Certain Cancer Uses

In addition to withdrawing Tazverik from the market, Ipsen has initiated steps to stop treatment with tazemetostat for all patients currently enrolled in the ongoing SYMPHONY-1 trial. All participants will receive standard of care, lenalidomide plus rituximab only.

Regulation | 09/03/2026 | By News Bureau |  128

XYRA Secures US Patent for Dose-Adjusted Budiodarone Therapy Targeting Atrial Fibrillation and Heart Failure Risk

XYRA receives a US patent protecting dose-adjusted budiodarone therapy for atrial fibrillation, aiming to reduce stroke and heart failure risk through patient monitoring while offering a safer rhythm-control option.

Regulation | 06/03/2026 | By News Bureau |  105

MHRA Approves Brensocatib as First Targeted Treatment for Non-Cystic Fibrosis Bronchiectasis in UK

UK regulator grants marketing authorisation to brensocatib (Brinsupri) for patients aged 12 and above with recurrent non-cystic fibrosis bronchiectasis flare-ups.

Regulation | 24/02/2026 | By News Bureau |  296

CDSCO to Outsource GMP Audits and Add 1,500 Experts to Boost Scientific Oversight

Central Drugs Standard Control Organisation has announced plans to strengthen its regulatory framework by outsourcing Good Manufacturing Practice (GMP) audits to accredited third-party agencies and expanding its scientific workforce by approximately 1,500 experts.

Regulation | 24/02/2026 | By Darshana |  248

CDSCO Flags 240 Drug Samples as Not of Standard Quality in January 2026

Central Drugs Standard Control Organisation has reported that 240 drug samples tested across India in January 2026 were found to be Not of Standard Quality (NSQ). Of these, 68 samples were identified by Central Drugs Laboratories, while 172 were flagged by State Drugs Testing Laboratories.

Regulation | 23/02/2026 | By Darshana |  603

FDA Issues Complete Response Letter for Disc Medicine's Bitopertin in Rare Blood Disorder

US regulator seeks Phase III APOLLO trial results before approving bitopertin for erythropoietic protoporphyria, pushing potential decision until mid-2027.

Regulation | 19/02/2026 | By News Bureau |  114

IPC Signs Three MoUs to Strengthen Medicine Safety and Quality Standards

The Indian Pharmacopoeia Commission (IPC)has signed three MoUs to strengthen medicine safety and quality, including partnerships with the Goa State Pharmacy Council (GSPC)and the Quality Council of India (QCI) to boost pharmacovigilance, training and healthcare quality initiatives.

Regulation | 10/02/2026 | By News Bureau |  134

FDA Issues 11 Observations to Aurobindo Pharma Manufacturing Facility

Aurobindo Pharma has reported that its formulation manufacturing facility in Telangana received 11 procedural observations from the United States Food and Drug Administration (FDA) after a routine inspection.

Regulation | 09/02/2026 | By Darshana |  569

GSK Wins European Nod for Nucala to Treat Eosinophilic COPD

GSK plc has received European Commission approval for Nucala (mepolizumab) as an add-on maintenance therapy for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterised by elevated blood eosinophils, despite treatment with inhaled triple therapy.

Regulation | 07/02/2026 | By Darshana |  153