The Central Drugs Standard Control Organisation (CDSCO), through its New Drugs Division, issued a circular dated 21 September 2026 highlighting the risks associated with the indiscriminate use of NSAIDs (painkillers)…
INTELLIGENT OVERVIEW Date: 18 September 2026Regulatory Authority: European Medicines Agency (EMA)Committee: Committee for Medicinal Products for Human Use (CHMP)Product: EnhertuActive Substance: Trastuzumab deruxtecanMarketing Authorisation Holder: Daiichi Sankyo Europe GmbHTherapeutic Area:…
The U.S. pharmaceutical market continued to see a mix of generic drug approvals, biologics, specialty therapies, and diagnostic radiopharmaceuticals during the week of 11–15 September 2026. The week's approvals covered…
Approval Date: 11-Sep-2026Applicant: Telix Pharmaceuticals (US) Inc.Product: PIXCLARA (floretyrosine F 18) injectionApplication: NDA 218592Regulatory Pathway: 505(b)(2) The U.S. Food and Drug Administration (USFDA) approved PIXCLARA (floretyrosine F 18) injection on…
Regulatory Event: USFDA Biologics License ApprovalApproval Date: 11 September 2026Applicant: Scholar Rock, Inc.BLA: 761463 Intelligence Overview The U.S. Food and Drug Administration (USFDA) has approved Isembyld® (apitegromab-mstn) injection, developed by…
Regulatory Event: USFDA New Drug ApprovalApproval Date: 14 September 2026Applicant: Curium US LLCNDA: 218525 Intelligence Overview The U.S. Food and Drug Administration (USFDA) has approved Bexlutry® (lutetium Lu 177 dotatate)…
Regulatory Authority: U.S. Food and Drug Administration (USFDA)Regulatory Event: BLA Approval – InterchangeabilityProduct: Garzulys (insulin aspart-fsan) injectionBLA: 761497/Original 2Approval Date: September 15, 2026Reference ID: 5869336 Regulatory Update The U.S. Food…
Seven Indian pharmaceutical companies received product approvals from the United States Food and Drug Administration (USFDA) between 3 September and 10 September 2026. The approvals cover products across dermatology, cardiovascular…
INTELLIGENCE BRIEFThe U.S. Food and Drug Administration (USFDA) granted multiple Abbreviated New Drug Application (ANDA) approvals between 03 and 10 September 2026, covering therapeutic areas including oncology, anticonvulsants, cardiovascular diseases,…
FDA Publishes Draft Guidance on Compounding Animal Drugs from Bulk Drug Substances Authority: U.S. Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM)Document: Draft Guidance for Industry GFI #256BDate:…