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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
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
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
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
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
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
Johnson & Johnson Secures FDA Priority Review for Imaavy in Rare Blood Disorder
Johnson & Johnson moves closer to delivering a first-in-class treatment for Warm Autoimmune Haemolytic Anaemia with FDA Priority Review for Imaavy.
Regulation | 28/04/2026 | By News Bureau
US FDA Approves CAPLYTA (lumateperone) sNDA for Schizophrenia Relapse Reduction
US Food and Drug Administration (FDA) approves CAPLYTA (lumateperone) sNDA for schizophrenia, showing a 63 percent reduction in relapse risk and 84 percent relapse-free patients over six months, with strong long-term safety and stability data.
Regulation | 28/04/2026 | By News Bureau
National Institute for Health and Care Research launches a nationwide collaboration to accelerate Parkinson’s research, bringing together academia, NHS and charities to drive faster development of treatments and diagnostics.
Regulation | 27/04/2026 | By News Bureau
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