News about Regulation

US FDA Approves Novo's Weekly Insulin Awiqli for Children

Novo’s Awiqli has received US FDA approval as the first and only once-weekly insulin for children aged 10 years and older with Type 2 Diabetes.

Regulation | 24/10/2026 | By News Bureau |  104

DoP Forms Committee to Review Pharma Marketing Practices

The Department of Pharmaceuticals has formed a committee to review UCPMP guidelines and strengthen pharmaceutical marketing oversight.

Regulation | 24/10/2026 | By News Bureau

CDSCO Flags 330 Drug Samples as NSQ in September 2026

CDSCO has flagged 330 drug samples as NSQ in September 2026, including 42 identified by central labs and 288 by state labs, and reports one spurious drug sample.

Regulation | 23/10/2026 | By News Bureau |  136

US FDA Approves GSK's Hibsago for Chronic Hepatitis B

The US FDA has approved GSK’s Hibsago (bepirovirsen) is for chronic hepatitis B, with phase 3 data showing improved functional cure rates after 6 months of treatment.

Regulation | 23/10/2026 | By News Bureau

US FDA Issues Final Guidance on Prescription Drug Apps and Software

The US FDA has issued final guidance on prescription drug apps and software, clarifying review requirements and labelling rules for drug-connected software.

Regulation | 22/10/2026 | By News Bureau

Dr. Reddy's Gets DCGI Approval for Zytorvi in Esophageal Cancer

Dr. Reddy’s has received DCGI approval for Zytorvi (toripalimab) in advanced esophageal cancer, marking its second approved indication in India.

Regulation | 21/10/2026 | By News Bureau

Zydus Gets US FDA Approval for Estradiol Patch

Zydus Lifesciences has received the US FDA approval for Estradiol and Levonorgestrel Transdermal System, eligible for 180-day CGT exclusivity.

Regulation | 21/10/2026 | By News Bureau |  102

US FDA Grants Dostarlimab Approval for Rectal Cancer

The US FDA has granted accelerated approval to GSK’s Jemperli (dostarlimab) for adults with stage 2/3 MSI-H or dMMR Locally Advanced Rectal Cancer (LARC).

Regulation | 21/10/2026 | By News Bureau |  102

Sun Pharma's Unloxcyt Gets Preferred NCCN Status

Sun Pharma's UNLOXCYT has received a Category 2A preferred designation in the updated NCCN guidelines for locally advanced Cutaneous Squamous Cell Carcinoma (laCSCC).

Regulation | 21/10/2026 | By News Bureau

EMA Recommends Rasonque's Authorisation for Metastatic Pancreatic Cancer

EMA recommends authorisation of Rasonque for metastatic pancreatic cancer following a phased data review under its Cancer Medicines Pathfinder project.

Regulation | 19/10/2026 | By News Bureau