Japan Approves VYVDURA® for At-Home Self-Injection in gMG and CIDP, Setting a Global Benchmark

VYVDURA® now approved for at-home self-injection in Japan for both generalized myasthenia gravis and CIDP argenx's VYVGART® and VYVDURA portfoli...

December 27, 2024 | Friday | News
Axcelead DDP and Astellas Partner in Japan to Advance Targeted Protein Degrader Discovery

Axcelead Drug Discovery Partners, Inc. (HQ: Fujisawa, Kanagawa, Japan; “Axcelead DDP”) announced that it has entered into a drug discovery se...

December 26, 2024 | Thursday | News
Fujirebio and Eisai Forge Partnership to Advance Blood-Based Diagnostics for Neurodegenerative Diseases

Fujirebio Holdings, Inc. (President & CEO: Goki Ishikawa; Head Office: Minato-ku, Tokyo), a wholly-owned subsidiary of H.U. Group Holdings, Inc. (Cha...

December 26, 2024 | Thursday | News
Regeneron’s EYLEA HD® Achieves Key Milestone in Phase 3 QUASAR Trial for Macular Edema Due to Retinal Vein Occlusion

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced the primary endpoint was met in the Phase 3 QUASAR trial investigating EYLEA HD® (af...

December 18, 2024 | Wednesday | News
Eli Lilly's Omvoh® (Mirikizumab) Receives Positive CHMP Opinion for Crohn’s Disease in the EU

Eli Lilly and Company (NYSE: LLY) announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human ...

December 16, 2024 | Monday | News
Mexico Approves Eisai and Biogen’s LEQEMBI for Early Alzheimer’s Disease Treatment

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusett...

December 09, 2024 | Monday | News
AstraZeneca’s Imfinzi Gains FDA Approval for Limited-Stage Small Cell Lung Cancer, Offering New Hope for Patients

AstraZeneca’s Imfinzi (durvalumab) has been approved in the US for the treatment of adult patients with limited-stage small cell lung cance...

December 09, 2024 | Monday | News
COFEPRIS Approves LEQEMBI® (Lecanemab) for Early Alzheimer's Disease in Mexico

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusett...

December 09, 2024 | Monday | News
Nxera Pharma Launches Phase 3 Trial of QUVIVIQ™ (Daridorexant) in South Korea to Address Insomnia Epidemic

Daridorexant is a dual orexin receptor antagonist being developed by Nxera for the treatment of adult patients with insomnia QUVIVIQ™ (daridorex...

December 05, 2024 | Thursday | News
Inari Medical Receives National Reimbursement Approval for ClotTriever Thrombectomy System in Japan

Inari Medical, Inc. (NASDAQ: NARI) (“Inari”), a medical device company with a mission to treat and transform the lives of patients suffering fr...

December 03, 2024 | Tuesday | News
Renalys Pharma's Sparsentan Receives Orphan Drug Designation for Primary IgA Nephropathy in Japan

Renalys Pharma, Inc., a late-stage clinical biopharmaceutical company announces that sparsentan, in-licensed from Travere Therapeutics, Inc. ("Trav...

December 02, 2024 | Monday | News
Adragos Pharma Acquires Baccinex, Strengthening Leadership in Aseptic Fill-Finish Across Europe, Japan, and Global Markets

Adragos Pharma, a global Contract Development and Manufacturing Organization (CDMO) headquartered in Munich, has announced the acquisition of Baccinex, a...

November 27, 2024 | Wednesday | News
GSK’s Blenrep Combination Therapy Accepted for FDA Review in Relapsed Multiple Myeloma

GSK plc (LSE/NYSE: GSK) announced the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for Blenrep&...

November 26, 2024 | Tuesday | News
MSD Announces Positive Phase 3 ZENITH Study Results for WINREVAIR in Pulmonary Arterial Hypertension

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced positive topline results from the Phase 3 ZENITH study evaluating WINREV...

November 26, 2024 | Tuesday | News

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