Neurizon Therapeutics Receives Positive Opinion on Orphan Medicinal Product Designation for NUZ-001 in Europe
Neurizon Therapeutics Limited (ASX: NUZ & NUZOA) ("Neurizon" or "the Company"), a clinical-stage biotech company advancing ...
European Medicines Agency Confirms Acceptance of Marketing Authorization Application for AVT05, a Proposed Biosimilar to Simponi® (golimumab)
Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for ...
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NUZ inks positive opinion on orphan product designation for NUZ-001 in Europe
Neurizon has been buoyed by the receipt of a positive opinion from the European Medicines Agency in relation to its ...
Pharmabiz2h
Johnson & Johnson seeks US & EU approvals for Darzalex Faspro/Darzalex as subcutaneous monotherapy for high-risk smoldering multiple myeloma
Johnson & Johnson seeks US & EU approvals for Darzalex Faspro/Darzalex as subcutaneous monotherapy for high-risk smoldering multiple myeloma: Raritan, New Jersey Monday, November ...
EU Critical Medicines Act: closer to ending overreliance on Asian manufacturers
China's virtual monopoly on the supply of many APIs could be dangerous for the security of medicine supply to Western ...
HotCopper.com on MSN7h
Neurizon's fast-track application for flagship drug in Europe received 'positively'
While the final decision is set for next month, biotech player Neurizon’s (ASX:NUZ) hopes have been lifted with a view ...
FiercePharma2d
J&J angles Darzalex for first move into early-stage myeloma with trial win, FDA filing
J&J’s filing is based on results from the phase 3 AQUILA trial. Among 390 patients with high-risk smoldering multiple myeloma ...
Praxis Precision Medicines Provides Corporate Update and Reports Third Quarter 2024 Financial Results
Interim analysis for Study 1 of Essential3 Phase 3 program for ulixacaltamide in essential tremor (ET) confirmed for Q1 2025; NDA filing ...
Johnson & Johnson submits applications for new indications for Darzalex
Johnson & Johnson announced the submission of regulatory applications to the U.S. FDA and European Medicines Agency seeking approval of a ...
Donald Trump and RFK Jr want to ‘Make America Healthy Again’. Where does that leave Europe?
New medicines, access to treatments, infectious disease monitoring, and more are on the table. View on euronews ...
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Shelley Gandhi Joins Firm – Headlines ELIQUENT’s Expanded Pharmacovigilance Service Offerings
Shelley Gandhi Joins Firm – Headlines ELIQUENT’s Expanded Pharmacovigilance Service Offerings ...
DRI Healthcare Trust Acquires Royalty in Pre-Approval Sebetralstat for Up to $179 Mln
The Canadian healthcare-focused royalty company said Monday that the royalty interest in the worldwide net sales of all formulations of sebetralstat from KalVista Pharmaceuticals was acquired for an ...