News about Regulation

US FDA Accepts EIT Pharma's Lonafarnib NDA for Treating Chronic Hepatitis D

EIT Pharma’s lonafarnib New Drug Application (NDA) has been accepted by the US Food and Drug Administration (FDA) for chronic hepatitis D, marking a key step toward a potential first oral treatment option.

Regulation | 13/08/2026 | By News Bureau |  138

Ivonescimab Plus Chemotherapy Approved in China for First-Line Squamous NSCLC

Ivonescimab plus chemotherapy has been approved in China for first-line squamous NSCLC, based on the HARMONi-6 Phase 3 trial and significant overall survival benefit.

Regulation | 13/08/2026 | By News Bureau |  230

Enhertu Plus Pertuzumab Approved in China for First-Line HER2-Positive Metastatic Breast Cancer

Enhertu plus pertuzumab has been approved in China as first-line treatment for HER2-positive metastatic breast cancer, based on positive phase 3 results.

Regulation | 13/08/2026 | By News Bureau |  166

Lilly Urges Action against Illegal Retatrutide Black Market

Eli Lilly has filed 6 new lawsuits against US entities selling illegal retatrutide products, escalating efforts to protect patients from the black market.

Regulation | 12/08/2026 | By News Bureau

Lupin Secures US Approval for Sodium Zirconium Cyclosilicate Oral Suspension

Lupin has received US Food and Drug Administration (FDA) approval for Sodium Zirconium Cyclosilicate Oral Suspension, 5 g and 10 g, bioequivalent to AstraZeneca’s Lokelma.

Regulation | 11/08/2026 | By News Bureau

EC Approves Bavarian Nordic's Mpox Vaccine for Children

European Commission (EC) approves Bavarian Nordic's MVA-BN mpox/smallpox vaccine for children aged 2-11 years, expanding protection against mpox, smallpox and vaccinia.

Regulation | 07/08/2026 | By News Bureau |  114

US FDA Approves Takeda's ORZEYFUL for Narcolepsy Type 1

US Food and Drug Administration (FDA) approves Takeda's ORZEYFUL (oveporexton), the first orexin therapy to treat the underlying cause of Narcolepsy Type 1 in adults.

Regulation | 07/08/2026 | By News Bureau |  128

Health Ministry Notifies Stricter Drug Rules against Fake Data

Union Health Ministry notifies stricter Drugs Rules, empowering licensing authorities to debar applicants submitting fake or fabricated data.

Regulation | 07/08/2026 | By News Bureau |  105

Dutch Court Orders Halt to Sale of Compounded Semaglutide Nasal Spray in Victory for Novo Nordisk

The Hague court rules in favour of Novo Nordisk, stopping the sale of an unapproved compounded semaglutide nasal spray and strengthening safeguards for pharmaceutical innovation and patient safety.

Regulation | 07/08/2026 | By News Bureau |  176

US FDA Accepts sBLA for ENFLONSIA to Expand RSV Indication

US Food and Drug Administration (FDA) and European Medicines Agency (EMA) accept applications for ENFLONSIA (clesrovimab-cfor) to expand RSV protection for high-risk children under 2 years of age during their second Respiratory Syncytial Virus (RSV) season.

Regulation | 07/08/2026 | By News Bureau |  162