News about Regulation

Piramal Pharma Completes US FDA Inspection at Lexington Facility

Piramal Pharma receives US FDA EIR with VAI status for its Lexington facility, marking successful closure of inspection and regulatory compliance.

Regulation | 13/04/2026 | By News Bureau |  243

Emalex Secures US Patent for Ecopipam ODT

Emalex secures a US composition-of-matter patent for its orally disintegrating ecopipam formulation, advancing drug development and expanding patient access.

Regulation | 10/04/2026 | By News Bureau |  239

European Medicines Agency Recommends Ending Use of Tecovirimat SIGA for Mpox Treatment

CHMP review finds no clinical benefit in mpox patients, while other approved uses of the antiviral remain unaffected.

Regulation | 30/03/2026 | By News Bureau |  332

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 |  286

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 |  182

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 |  166

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 |  538

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 |  320

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 |  1844

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 |  166