News about Regulation

Biocon Malaysia Gets MHRA Approval for Insulin Unit

Biocon has received UK MHRA approval for its new drug product fill-finish unit for Semglee (insulin glargine) at its Malaysia facility.

Regulation | 25/09/2026 | By News Bureau

US FDA Approves Lirafugratinib for Cholangiocarcinoma

US FDA has approved lirafugratinib for previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma.

Regulation | 25/09/2026 | By News Bureau

EU Approves Trixeo for Asthma Maintenance Treatment

Trixeo is approved in the EU for asthma maintenance treatment, becoming the first and only triple-combination therapy for patients aged 12 years and older.

Regulation | 24/09/2026 | By News Bureau

Glenmark Goa Plant Gets VAI Status from US FDA

Glenmark Pharmaceuticals has received Establishment Inspection Report (EIR) from US FDA for its Goa facility with VAI classification.

Regulation | 23/09/2026 | By News Bureau |  122

US FDA Grants Priority Review to Insmed's sNDA for ARIKAYCE

US FDA has granted Priority Review (PR) to Insmed’s ARIKAYCE sNDA for MAC Lung Disease; PDUFA Action Date Set for January 28, 2027.

Regulation | 22/09/2026 | By News Bureau |  142

US FDA Approves Finerenone for CKD in Type 1 Diabetes

The US FDA has approved finerenone for a new indication: treating Chronic Kidney Disease associated with Type 1 Diabetes in patients.

Regulation | 21/09/2026 | By News Bureau |  122

US FDA Approves Inluriyo in Combination with Verzenio

US FDA has approved Inluriyo (imlunestrant) plus Verzenio (abemaciclib) for adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer.

Regulation | 21/09/2026 | By News Bureau

Biocon's Pertuzumab Gets EMA CHMP Approval Nod

Biocon’s pertuzumab biosimilar has received a positive EMA CHMP opinion following review of its Marketing Authorisation (MA) application.

Regulation | 21/09/2026 | By News Bureau

Ultragenyx Gets US FDA Nod for First MPS IIIA Gene Therapy

US FDA has approved Ultragenyx's FAYUVI, first-ever gene therapy for Sanfilippo Syndrome Type A (MPS IIIA), the company's second gene therapy approval.

Regulation | 21/09/2026 | By News Bureau |  111

US FDA OKs First Gene Therapy for Sanfilippo Syndrome A

The US FDA has approved the first gene therapy for pediatric patients with Sanfilippo Syndrome Type A, a rare and progressive neurodevelopmental disease.

Regulation | 19/09/2026 | By News Bureau