Psoriatic Arthritis
Jun 17, 2025
Celltrion Announces FDA Nod for New STEQEYMA Presentation to Broaden Pediatric Use; CSL’s ANDEMBRY Gets FDA Nod as First Factor XIIa Inhibitor for Hereditary Angioedema; Ocugen’s OCU410ST Cleared by FDA to Begin Phase II/III Trial in Stargardt Disease; Milestone Pharmaceuticals Submits FDA Response for CARDAMYST in PSVT; AbbVie’s MAVYRET Approved by FDA as First and Only Therapy for Acute Hepatitis C
Celltrion Announces FDA Approval of New STEQEYMA Presentation, Expanding Pediatric Dosing Options Celltrion, Inc. has announced that the FDA has approved an additional presentation of STEQEYMA (ustekinumab-stba), a biosimilar to STELARA, in a 45mg/0.5mL single-dose vial for subcutaneous injection. This new formu...
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Sep 24, 2024
Zevra’s MIPLYFFA Niemann-Pick Disease Approval; FASENRA Approved for Eosinophilic Granulomatosis; Sanofi’s SARCLISA Gets Multiple Myeloma Approval; RYBREVANT Combo Gets FDA Nod for EGFR Lung Cancer; UCB’s BIMZELX Receives Multiple Approval from the FDA
FDA Greenlights Zevra Therapeutics’ MIPLYFFA for Niemann-Pick Disease Type C Zevra Therapeutics, Inc. has announced that the FDA has approved MIPLYFFA (arimoclomol) capsules as the first oral treatment for Niemann-Pick disease type C. Indicated for use alongside miglustat, MIPLYFFA is intended for both adult and...
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Mar 11, 2024
Giant-Cell Arteritis Treatment Beyond Glucocorticoids: Exploring Horizons
Giant-cell arteritis (GCA), alternatively referred to as temporal arteritis, is a form of vasculitis primarily impacting arteries, particularly those in proximity to the temples. If left untreated, it may result in notable complications such as loss of vision. Diagnosis of the disease is often complicated by its pr...
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Oct 28, 2022
HUMIRA Biosimilars in the US: The Talk of the Psoriatic Arthritis Treatment Market
Psoriatic arthritis (PsA) is a type of chronic inflammatory arthritis that affects approximately 1 in every 10 people with psoriasis. According to the National Psoriasis Foundation, psoriasis is most common in adults aged 30 to 50. However, psoriatic arthritis can develop at any age, including children. Accordin...
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Jan 25, 2022
Merck’s Gefapixant; Pfizer’s Somatrogon; Gilead’s Viklury; AbbVie’s Skyrizi; Gilead’s Zydelig Approvals; Lantern’s LP-184; Polpharma to Acquire Advent
Merck’s Chronic Cough Med Gefapixant Receives A Red Flag From the FDA, Requests For More Data On 24th January 2022, Merck & Co. announced FDA rejection for its New Drug Application (NDA) of Gefapixant (experimental drug) for unexplained or chronic cough. FDA asked for additional information on the drug, rela...
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