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Tag: intravenous infusion

Rani Therapeutics and ProGen Announce Late Breaking Presentation at ENDO 2025 Demonstrating Bioequivalence of Novel, Bispecific GLP-1/GLP-2 Receptor Agonist Delivered Orally via RaniPill Compared...

SAN JOSE, Calif., July 14, 2025 (GLOBE NEWSWIRE) -- Rani Therapeutics Holdings, Inc. (“Rani Therapeutics” or “Rani”) (Nasdaq: RANI), a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs, today announced that it will present preclinical data on the RaniPill® capsule at the Endocrine Society’s Annual Meeting (ENDO 2025) taking place July 12-15 in San Francisco, CA.

Ultragenyx Receives Complete Response Letter from FDA for UX111 AAV Gene Therapy to Treat Sanfilippo Syndrome Type A (MPS IIIA)

Complete Response Letter (CRL) cited specific chemistry, manufacturing and controls (CMC) related observations that are resolvable

Lynozyfic™ (linvoseltamab-gcpt) Receives FDA Accelerated Approval for Treatment of Relapsed or Refractory Multiple Myeloma

Lynozyfic is a bispecific antibody directing T cells to kill multiple myeloma cancer cells; multiple myeloma is the second most common blood cancer 

Jazz Pharmaceuticals Receives European Commission Marketing Authorization for Ziihera® (zanidatamab) for the Treatment of Advanced HER2-Positive Biliary Tract Cancer

– Conditional approval based on positive results from the HERIZON-BTC-01 Phase 2b trial – DUBLIN, July 1, 2025 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ)...

GC Biopharma USA Highlights Innovative Manufacturing Approach to IVIG Safety at 2025 CIS Annual Meeting

Differences in manufacturing processes impact the tolerability of intravenous immune globulin (IVIG) products GC Biopharma's manufacturing process reduces FXIa to undetectable levels – a critical...

Celltrion announces U.S. FDA approval of additional presentation of STEQEYMA® (ustekinumab-stba), expanding dosing options for pediatric patients

Approval of 45mg/0.5mL solution in a single-dose vial for subcutaneous injection expands dosing flexibility for pediatric patients with plaque psoriasis (PsO) or psoriatic arthritis...

Intellia Therapeutics Announces Positive Three-Year Data from Phase 1 Trial of Lonvoguran Ziclumeran (lonvo-z) in Patients with Hereditary Angioedema (HAE) at the European Academy...

CAMBRIDGE, Mass., June 15, 2025 (GLOBE NEWSWIRE) -- Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies, today announced three-year follow-up data from the Phase 1 portion of the ongoing Phase 1/2 study in patients with HAE after receiving a single dose of lonvoguran ziclumeran (lonvo-z, also known as NTLA-2002). Results were shared in an oral presentation at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2025, held June 13-16 in Glasgow, United Kingdom.

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