News about Regulation

Roche's Elecsys pTau217 Gets US FDA Clearance for Alzheimer's Assessment

Roche’s Elecsys pTau217 receives US Food and Drug Administration (FDA) clearance as a blood test for Alzheimer’s amyloid pathology assessment across primary and specialty care settings.

Regulation | 25/08/2026 | By News Bureau |  115

Japan Approves Bayer's Sevabertinib for HER2-Mutant NSCLC

Japan approves Bayer’s sevabertinib as the first targeted therapy for HER2-mutant NSCLC, including first-line use, based on phase 1/2 SOHO-01 results.

Regulation | 25/08/2026 | By News Bureau |  140

EU Expands Trodelvy Use in First-Line Metastatic Triple-Negative Breast Cancer

The European Commission (EC) approves Trodelvy plus pembrolizumab for first-line PD-L1-positive metastatic Triple-Negative Breast Cancer (TNBC), expanding its use across PD-L1 status.

Regulation | 25/08/2026 | By News Bureau |  127

Biocon's Pegfilgrastim Biosimilar Gets Japan MHLW Approval

Biocon’s pegfilgrastim biosimilar receives Japan MHLW marketing approval, strengthening the company’s biosimilar portfolio and expanding access in Japan.

Regulation | 25/08/2026 | By News Bureau |  123

Japan Approves Takeda's ORZEYFUL (Oveporexton) for Narcolepsy Type 1

Japan approves ORZEYFUL (oveporexton) as the first and only medicine targeting the underlying cause of narcolepsy type 1, following positive phase 3 results.

Regulation | 24/08/2026 | By News Bureau |  146

EU Approves DAYBU (Trofinetide) for Rett Syndrome

The European Commission (EC) approves DAYBU (trofinetide) as the first and only treatment for Rett syndrome neurobehavioral symptoms across the European Union (EU) and EEA.

Regulation | 24/08/2026 | By News Bureau

Aurobindo Pharma's Lannett Facility Completes US FDA Inspection with 4 Observations

Aurobindo Pharma’s Lannett facility in Indiana completes a US Food and Drug Administration (FDA) inspection with 4 procedural observations and will respond within the stipulated timeline.

Regulation | 24/08/2026 | By News Bureau

Strides Receives US FDA EIR for Flagship Facility in Bengaluru

Strides receives the US Food and Drug Administration (FDA) Establishment Inspection Report (EIR) for its flagship Bengaluru facility following a current Good Manufacturing Practice (cGMP) inspection conducted in May 2026.

Regulation | 20/08/2026 | By News Bureau

Silo Pharma Receives Canadian Patent Allowance for Novel PTSD Treatment

Silo Pharma receives a Notice of Allowance for its Canadian patent application covering a novel Post-Traumatic Stress Disorder (PTSD) treatment, strengthening its global Intellectual Property (IP) portfolio.

Regulation | 19/08/2026 | By News Bureau |  107

UK MHRA Outlines Regulatory Framework for Microbiome-Based Medicines

The UK Medicines and Healthcare products Regulatory Agency (MHRA) publishes a position paper outlining the UK licensing route for microbiome-based medicines, helping developers advance innovative therapies to patients.

Regulation | 19/08/2026 | By News Bureau