Yahoo Finance

Eisai and Biogen’s subcutaneous Leqembi set for FDA review

Eisai and Biogen are one step away from deploying a more convenient version of their jointly developed Alzheimer’s treatment Leqembi (lecanemab-irmb) after the US Food and Drug Administration (FDA) ...
Business Wire

Innovative Health Sciences Receives FDA Clearance for Insignis™ Subcutaneous Needle Sets

CHESTER, N.Y.--(BUSINESS WIRE)--Innovative Health Sciences, LLC (“IHS” or the “Company”) management announced today that IHS has received FDA clearance for its Insignis™ Subcutaneous Needle Sets. This ...
Yahoo Finance

Takeda Announces Approval of HYQVIA® 10% S.C. (Subcutaneous) Injection Set in Japan for Patients with Agammaglobulinemia or Hypogammaglobulinemia

OSAKA, Japan & CAMBRIDGE, Mass., December 27, 2024--(BUSINESS WIRE)--Takeda (TSE:4502/NYSE:TAK) today announced that the Japanese Ministry of Health, Labour and Welfare has approved the use of HYQVIA ...
Seeking Alpha

Halozyme Announces Takeda Received Regulatory Approval for HYQVIA® 10% Subcutaneous Injection Set with ENHANZE® in Japan for Patients with Agammaglobulinemia or ...

SAN DIEGO, Dec. 30, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (HALO) (Halozyme) today announced that Takeda received regulatory approval for HYQVIA ® [Immune Globulin Infusion 10% (Human) with ...

KORU Medical Systems Announces 510(k) Submission for Clearance of the FreedomEDGE® System with a Commercialized Oncology Biologic

KORU Medical Systems, Inc. (NASDAQ: KRMD) ("KORU Medical" or the "Company"), a leading medical technology company focused on ...
Business Wire

KORU Medical Systems, Inc. Receives FDA 510(k) Clearance for FREEDOM60® Infusion System With Hizentra® 50 ML Prefilled Syringes

MAHWAH, N.J.--(BUSINESS WIRE)--KORU Medical Systems, Inc. (NASDAQ: KRMD) ("KORU Medical" or the "Company"), a leading medical technology company focused on the development, manufacturing, and ...
Yahoo Finance

Roche’s OCREVUS twice-yearly, 10-minute subcutaneous injection was non-inferior to intravenous infusion and provided near-complete suppression of brain lesions

Basel, 11 October 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced late-breaking data from the Phase III OCARINA II study. Study results demonstrate the effect of OCREVUS® (ocrelizumab) as an ...
Medindia

FDA Approves Marketing of RMS Subcutaneous Needle Sets

CHESTER, N.Y., June 1, 2011 /PRNewswire/ -- Repro-Med Systems, Inc., (REPR.PK) announced today that it has received approval from the Food and Drug Administration (FDA) to begin U.S. marketing of its ...
Nasdaq

Supernus Pharmaceuticals Announces FDA Approval of ONAPGO, the First Subcutaneous Apomorphine Infusion Device for Parkinson's Disease in the U.S.

ONAPGO, a subcutaneous infusion device, treats motor fluctuations in advanced Parkinson's disease and launches in the U.S. in 2025. Supernus Pharmaceuticals has announced the FDA approval of ONAPGO, ...
MedPage Today

Subcutaneous Ocrelizumab Not Inferior to IV Infusion

MILAN -- An investigational 10-minute subcutaneous injection of ocrelizumab (Ocrevus) was non-inferior to the established IV infusion formulation of the drug in multiple sclerosis (MS), the phase III ...
Stockhouse

Takeda Announces Approval of HYQVIA® 10% S.C. (Subcutaneous) Injection Set in Japan for Patients with Agammaglobulinemia or Hypogammaglobulinemia

Takeda (TSE:4502/NYSE:TAK) today announced that the Japanese Ministry of Health, Labour and Welfare has approved the use of HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant ...