News about Regulation

US FDA Approves Utebzi for Adult Patients with Complicated UTIs

The US Food and Drug Administration (FDA) has approved GSK’s Utebzi (tebipenem pivoxil) for adults with complicated Urinary Tract Infections (cUTIs), becoming the first and only oral carbapenem antibiotic available. The approval is based on the phase 3 PIVOT-PO trial, which demonstrated non-inferiority to standard intravenous antibiotic treatment.

Regulation | 19/06/2026 | By News Bureau

US FDA Accepts Roche's Lunsumio-Polivy Filing for Relapsed Large B-Cell Lymphoma

The US Food and Drug Administration (FDA) has accepted Roche’s supplemental Biologics License Application for the Lunsumio and Polivy combination in relapsed or refractory large B-cell lymphoma. The filing is supported by Phase 3 SUNMO study data showing a 59 percent reduction in the risk of disease progression or death.

Regulation | 19/06/2026 | By News Bureau

TGA Issues New Guidance on Prescription Medicine Advertising Rules

Australia’s Therapeutic Goods Administration (TGA) has released updated guidance on prescription medicine advertising restrictions, providing practical examples to help businesses and individuals understand compliance requirements and meet their regulatory obligations.

Regulation | 19/06/2026 | By News Bureau

IPC Represents India at the 16th International Meeting of World Pharmacopoeias in Brazil

The Indian Pharmacopoeia Commission (IPC) represented India at the 16th International Meeting of World Pharmacopoeias in Brazil, highlighting advances in pharmacopoeial standards and global harmonisation. India’s leadership in setting quality standards for complex medicines and strengthening international regulatory collaboration was widely recognised.

Regulation | 18/06/2026 | By News Bureau

Allergan Aesthetics Secures US FDA Approval for Skinvive to Treat Neck Wrinkles

Allergan Aesthetics has received the US Food and Drug Administration (FDA) approval for Skinvive by Juvéderm to reduce neck wrinkles and improve overall neck appearance. The injectable treatment helps the skin retain moisture, softness and smoothness, providing a first-of-its-kind option for addressing age-related and ‘tech-neck’ lines.

Regulation | 18/06/2026 | By News Bureau

US FDA Expands OTC Access to Naloxone Nasal Spray for Opioid Overdose

US FDA expands Over-the-Counter (OTC) access to naloxone nasal spray for opioid overdose, supporting efforts to prevent overdose deaths and strengthen addiction recovery initiatives under the US government’s public health strategy.

Regulation | 18/06/2026 | By News Bureau

Zai Lab Secures EMA Orphan Drug Status for Zoci in Pulmonary Neuroendocrine Carcinomas

Zai Lab has received EMA Orphan Drug Designation (ODD) for zocilurtatug pelitecan (zoci) in pulmonary neuroendocrine carcinomas. The designation recognises promising clinical data suggesting potential benefits over existing therapies for patients with relapsed or refractory extensive-stage Small Cell Lung Cancer (SCLC).

Regulation | 17/06/2026 | By News Bureau

US FDA Classifies Aurobindo Pharma's Eugia Unit-III Inspection as Official Action Indicated

Aurobindo Pharma said the US FDA has classified its inspection of Eugia Unit-III in Telangana as Official Action Indicated, while reaffirming its commitment to maintaining global quality manufacturing standards.

Regulation | 16/06/2026 | By News Bureau

Health Ministry Ends Cough Syrup Sale Exemption in Villages

The Union Ministry of Health and Family Welfare has amended the Drugs Rules, 1945, withdrawing the exemption for cough syrup sales in small villages. The move strengthens regulatory oversight and aims to improve monitoring, safety, and control of cough syrup distribution across India.

Regulation | 16/06/2026 | By News Bureau

US FDA Accepts Gilead's Once-Weekly Yeztugo for HIV Prevention

Gilead’s investigational once-weekly oral HIV prevention pill Yeztugo has been accepted for US FDA review, supported by strong clinical data showing high efficacy of lenacapavir in preventing HIV across 2 clinical trials. The therapy could become the first long-acting oral option for HIV prevention.

Regulation | 16/06/2026 | By News Bureau