News about Regulation

ZYUS Life Sciences Secures Second US Pain Management Patent

ZYUS Life Sciences secures a second US pain management patent, strengthening its IP portfolio and supporting clinical research in chronic pain and neuropathic pain.

Regulation | 07/05/2026 | By News Bureau

Nuvation Bio Secures FDA Nod for IBTROZI sNDA in ROS1-Positive Non-Small Cell Lung Cancer

Nuvation Bio secures US Food and Drug Administration (FDA) acceptance of IBTROZI (taletrectinib) sNDA for ROS1-positive Non-Small Cell Lung Cancer (NSCLC), with updated response data and a target action date of January 4, 2027.

Regulation | 07/05/2026 | By News Bureau |  128

Anuh Pharma Gets Prequalification Nod from WHO for Anti-Malarial Bulk Drug

Anuh Pharma receives World Health Organization (WHO) prequalification for Amodiaquine Hydrochloride API, an essential anti-malarial medicine used in combination therapies for Plasmodium falciparum malaria.

Regulation | 06/05/2026 | By News Bureau

US FDA Proposes Excluding Semaglutide, Tirzepatide and Liraglutide from 503B Bulks List

The US Food and Drug Administration (FDA) proposes excluding semaglutide, tirzepatide, and liraglutide from the 503B bulks list, citing no clinical need for compounding these GLP-1 drugs by outsourcing facilities.

Regulation | 04/05/2026 | By News Bureau |  112

WHO Opens Applications for 2027 Essential Medicines List Update

The World Health Organization (WHO) opens applications for the 2027 update of the Model Lists of Essential Medicines, with submissions accepted until November 6, 2026.

Regulation | 04/05/2026 | By News Bureau

Eli Lilly and Company Backs Haryana State FDA Action Against Counterfeit Drugs

Eli Lilly and Company supports Haryana State FDA action against counterfeit medicines, providing guidance on safe procurement and product identification to ensure patient safety and drug authenticity.

Regulation | 01/05/2026 | By News Bureau |  119

Henlius and Organon Win EC Nod for POHERDY, Biosimilar to PERJETA

European Commission (EC) approves Shanghai Henlius Biotech Inc. and Organon & Co.’s POHERDY (pertuzumab), the first PERJETA biosimilar in Europe, backed by strong analytical, clinical, safety, and immunogenicity data.

Regulation | 30/04/2026 | By News Bureau |  132

Orca Bio Receives US FDA RMAT Designation for Orca-Q in Blood Cancers

Orca Bio receives US Food and Drug Administration (FDA) RMAT designation for Orca-Q in high-risk hematologic malignancies, backed by promising phase 1 data on survival and GVHD outcomes, with further results expected in 2026.

Regulation | 30/04/2026 | By News Bureau |  103

AbbVie Submits FDA Application for SKYRIZI Subcutaneous Induction in Crohn's Disease

AbbVie Inc. submits an application to the US Food and Drug Administration (FDA) for SKYRIZI (risankizumab-rzaa) subcutaneous induction in Crohn’s disease, supported by Phase 3 AFFIRM data, offering a potential new treatment option.

Regulation | 29/04/2026 | By News Bureau |  150

Dr. Reddy's Laboratories Wins Health Canada Nod for Generic Semaglutide Injection

Dr. Reddy's Laboratories secures Health Canada approval for generic semaglutide injection, becoming the first to gain market authorisation in Canada ahead of the review timeline.

Regulation | 29/04/2026 | By News Bureau |  153