News about Regulation

Maharashtra FDA Cancels Cipla Pharma's C&F Drug Licences in Pune Over Regulatory Violations

Maharashtra FDA has cancelled Cipla Pharma & Life Sciences’ C&F drug sale and distribution licences at Vadki, Pune, citing violations linked to misbranded ‘Reactin Plus’ tablets, storage deficiencies, inventory discrepancies and non-compliance with recall directions.

Regulation | 31/08/2026 | By News Bureau

IMA Issues Nationwide Advisory as Seasonal H1N1 Cases Rise Across India

The Indian Medical Association has issued a nationwide advisory amid rising seasonal H1N1 cases, urging people to avoid self-medication, follow preventive measures and seek timely medical care for severe symptoms.

Regulation | 27/08/2026 | By News Bureau

US FDA Approves First in Class Targeted Therapy for Metastatic Pancreatic Cancer

The US Food and Drug Administration (FDA) has approved the first targeted therapy for metastatic pancreatic cancer, advancing an innovative treatment option for patients with limited choices.

Regulation | 27/08/2026 | By News Bureau

IPC Organises First-Ever Interactive Meeting with CDL Kolkata to Promote Quality of Medicines

The Indian PharmaCopoeia Commission (IPC) holds its first interactive meeting with CDL Kolkata to strengthen Indian Pharmacopoeia (IP) standards and launches 7 nitrosamine impurity reference standards.

Regulation | 27/08/2026 | By News Bureau

US FDA Approves Ziihera for First-Line HER2+ Gastroesophageal Cancer

The US Food and Drug Administration (FDA) approves Ziihera plus tislelizumab and chemotherapy for first-line treatment of HER2+ advanced gastroesophageal adenocarcinoma regardless of PD-L1 status.

Regulation | 26/08/2026 | By News Bureau

US FDA Approves IMAAVY as First Treatment for Warm Autoimmune Hemolytic Anemia

The US Food and Drug Administration (FDA) has approved IMAAVY (nipocalimab-aahu) as the first treatment for warm autoimmune hemolytic anemia, based on durable hemoglobin responses in phase 2/3.

Regulation | 26/08/2026 | By News Bureau

Vanda Pharma's Imsidolimab Gets EU Orphan Designation for Psoriasis

Vanda Pharmaceuticals’ imsidolimab receives European Union (EU) orphan designation for Generalised Pustular Psoriasis (GPP), marking the first such designation for a GPP treatment in the EU.

Regulation | 26/08/2026 | By News Bureau

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

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

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