News about Regulation

EMA Accepts Bexsero Label Update for Meningitis B Booster

The European Medicines Agency (EMA) has accepted a label update for Bexsero that could enable a single booster dose to protect individuals aged 10 years and older previously vaccinated against Meningitis B.

Regulation | 21/07/2026 | By News Bureau |  156

Roche's Gazyva Receives US FDA Priority Review for Membranous Nephropathy

The US Food and Drug Administration (FDA) has granted Priority Review to Roche's Gazyva for primary membranous nephropathy, supported by phase 3 MAJESTY trial results showing superior complete remission versus tacrolimus.

Regulation | 17/07/2026 | By News Bureau |  169

IPC Signs MoU with UPPPC to Strengthen Quality, Innovation, and Regulatory Excellence in Healthcare

The Indian Pharmacopoeia Commission (IPC) has signed a Memorandum of Understanding (MoU) with Uttar Pradesh Promote Pharma Council (UPPPC) to enhance pharmaceutical quality, healthcare innovation, regulatory compliance, and MSME support through digital reporting tools.

Regulation | 16/07/2026 | By News Bureau |  107

UK and EU Drug Regulators Sign Working Arrangement

The UK government and the EU Drugs Agency have signed a working arrangement to strengthen regulatory cooperation, protect public health, and reduce drug-related harms.

Regulation | 16/07/2026 | By News Bureau |  129

Leiutis Pharma Announces CDSCO Approval for World's First Synthetic CBD Anxiety Therapy

Leiutis Pharmaceuticals has received CDSCO approval for the world's first synthetic CBD oral solution to treat mild to moderate anxiety disorders alongside cognitive behavioral therapy.

Regulation | 15/07/2026 | By News Bureau |  1885

US FDA Accepts BioMarin's sNDA for VOXZOGO in Achondroplasia

The US Food and Drug Administration (FDA) has accepted BioMarin's sNDA for VOXZOGO in achondroplasia, supported by long-term safety and efficacy data, including adult height, body proportionality, and arm span outcomes.

Regulation | 14/07/2026 | By News Bureau |  149

US FDA Approves Leqembi Iqlik Subcutaneous Injection for Early Alzheimer's Disease

The US Food and Drug Administration (FDA) has approved Leqembi Iqlik (lecanemab-irmb) as a once-weekly subcutaneous starting dose for early Alzheimer's Disease (AD), with a U.S. launch planned for August 2026.

Regulation | 14/07/2026 | By News Bureau |  124

NMPA Reviews QMS for Vaccine and Drug GMP Compliance

China's NMPA has completed a QMS management review to strengthen vaccine and drug Good Manufacturing Practice (GMP) compliance, supporting WHO WLA standards and PIC/S regulatory requirements.

Regulation | 13/07/2026 | By News Bureau |  143

US FDA Approves PADCEV Plus Keytruda for Muscle-Invasive Bladder Cancer

The US Food and Drug Administration (FDA) has approved PADCEV plus Keytruda as the first and only platinum-free neoadjuvant and adjuvant treatment for adults with Muscle-Invasive Bladder Cancer (MIBC), regardless of cisplatin eligibility.

Regulation | 13/07/2026 | By News Bureau |  150

US FDA Proposes New Rule to Modernise Drug Manufacturing Registration

The US Food and Drug Administration (FDA) has proposed a new rule to modernise drug manufacturing registration, streamline advanced distributed manufacturing, and improve visibility into foreign drug supply chains.

Regulation | 13/07/2026 | By News Bureau |  109