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The European Union (EU) has approved Enhertu plus pertuzumab as a new first-line regimen for HER2-positive metastatic breast cancer, reducing progression or death risk by 44 percent.
Regulation | 02/09/2026 | By News Bureau | 101
US FDA Approves Gilead's Bixlenvo for Once-Daily HIV Treatment
The US Food and Drug Administration (FDA) approves Gilead’s Bixlenvo, a once-daily single-tablet HIV treatment combining bictegravir and lenacapavir for virologically suppressed adults.
Regulation | 01/09/2026 | By News Bureau
US FDA Approves First Drug for Polycythemia Vera
The US Food and Drug Administration (FDA) has approved the first-in-class drug for polycythemia vera, targeting the underlying biology driving excessive Red Blood Cell (RBC) production.
Regulation | 31/08/2026 | By News Bureau | 119
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 | 150
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 | 102
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 | 125
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 | 106
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 | 132
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
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