Date: 20-Oct-2026Regulatory Authority: US Food and Drug Administration (USFDA)Applicant: GlaxoSmithKline LLCApplication Number: NDA 221276 The US Food and Drug Administration (USFDA) approved Hibsago (bepirovirsen) injection, developed by GlaxoSmithKline LLC, in…
Date: 19-Oct-2026Regulatory Authority: US Food and Drug Administration (USFDA)Applicant: Fresenius Medical Care Renal Therapies Group, LLC the US Food and Drug Administration (USFDA) approved two new drug applications (NDAs) submitted…
Date: 16-Oct-2026 On 16 October 2026, the U.S. Food and Drug Administration (USFDA) approved BRYTLY (apraclonidine ophthalmic solution 0.125%), developed by Alcon Laboratories, Inc., as a nonprescription treatment for eye…
Approval Date: 09-October-2026Regulatory Authority: U.S. Food and Drug Administration (USFDA)Applicant: AiCuris Anti-infective Cures AGApplication Type: New Drug Application (NDA 221154)Active Ingredient: PritelivirTherapeutic Area: Infectious Diseases | Antiviral Therapy The U.S.…
23 September 2026 | U.S. FDA Regulatory Update The U.S. Food and Drug Administration (FDA) has approved Lirafugratinib (Lyrfigtu) capsules, developed by Elevar Therapeutics Inc., under NDA 220425. The approval…
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)…