Plaque Psoriasis
Mar 24, 2026
Sanofi’s Venglustat Gains US Breakthrough Therapy Nod, Boosting Hope for Type 3 Gaucher Disease; Rhythm Pharmaceuticals Expands IMCIVREE Label with FDA Approval in Hypothalamic Obesity; FDA Approves LYNAVOY for Cholestatic Pruritus in PBC Patients; FDA Greenlights J&J/Protagonist’s ICOTYDE, Redefining First-Line Systemic Therapy for Plaque Psoriasis; Novartis Strengthens its Breast Cancer Portfolio Through Acquisition of a Pan-mutant PI3Kα Inhibitor
Sanofi Wins US Breakthrough Therapy Tag for Venglustat in Type 3 Gaucher Disease The US Food and Drug Administration (FDA) has awarded Breakthrough Therapy designation to venglustat, an investigational oral glucosylceramide synthase inhibitor (GCSi), for treating neurological symptoms associated with type 3 Gauc...
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Mar 23, 2026
J&J and Protagonist’s ICOTYDE Ushers in First-in-Class Oral IL-23 Therapy
Summary Johnson & Johnson and Protagonist Therapeutics received U.S. FDA approval for ICOTYDE (icotrokinra), the first targeted oral IL-23 receptor peptide therapy for moderate-to-severe plaque psoriasis in adults and adolescents (12+ years, ≥40 kg). Once-daily 200 mg oral tablet blocks IL-23 signaling w...
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Sep 30, 2025
Regeneron’s EVKEEZA Wins FDA Approval for HoFH in Children as Young as 1 Year; Eli Lilly’s INLURIYO Approved for ER+, HER2-, ESR1-Mutated Advanced Breast Cancer; Janssen’s TREMFYA Secures FDA Nod for Pediatric Plaque Psoriasis and Psoriatic Arthritis; Kedrion Biopharma’s QIVIGY Approved for Primary Humoral Immunodeficiency in Adults; Crinetics Pharma Wins FDA Approval for First Daily Pill, PALSONIFY, for Rare Growth Disorder
Regeneron’s EVKEEZA Wins FDA Approval for HoFH in Children as Young as 1 Year Regeneron Pharmaceuticals, Inc. announced that the FDA has approved EVKEEZA (evinacumab-dgnb) ANGPTL3 antibody, for children aged 1 to under 5 years with homozygous familial hypercholesterolemia (HoFH). This expands the indication from...
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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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Apr 19, 2024
Revolutionizing Psoriasis Treatment: Advancements in the US Market
Psoriasis is one of the most frequent chronic inflammatory dermatoses in the world, with variable prevalence globally. Important factors in the variation of the prevalence of psoriasis include age, gender, geography, and ethnicity, probably due to genetic and environmental factors. Higher prevalence rates have been...
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Oct 24, 2023
FDA Approves PENBRAYA for Most Common Serogroups Causing Meningococcal Disease; BIMZELX Approved Moderate to Severe Plaque Psoriasis; FDA Approves BioMarin’s VOXZOGO; FDA Fast Track Designation to ANPD001 for Parkinson’s Disease; UCB Announces FDA Approval of ZILBRYSQ; EMA Granted Orphan Drug Designation to Lisata’s LSTA1
UCB announces FDA approval of ZILBRYSQ for the Treatment of Adults with Generalized Myasthenia Gravis On the 17th of October 2023, UCB (Euronext Brussels: UCB) made an announcement regarding the approval of ZILBRYSQ® (zilucoplan) by the US FDA for the management of generalized myasthenia gravis (gMG) in adult pa...
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Apr 07, 2023
What Does the Future of Plaque Psoriasis Treatment Market Look Like?
Psoriasis is a common skin condition that accelerates the life cycle of skin cells. More than 3% of the adult population in the United States suffers from psoriasis. That equates to more than 7.5 million US adults. According to the World Psoriasis Day Consortium, 125 million people worldwide (2-3% of the total popu...
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Mar 21, 2023
AbbVie Announces Results of Study Evaluating SKYRIZI; FDA Fast Track Designation to Arrowhead’s ARO-APOC3; FDA Approves Dabrafenib Plus Trametinib for BRAF V600E–Mutated Low-Grade Glioma; FDA Grants ODD to Novel BRAF Inhibitor for Brain/CNS Malignancies; EP0042 Wins FDA Orphan Drug Status; Karuna Therapeutics Announces Results from Phase 3 EMERGENT-3 Trial of KarXT in Schizophrenia
AbbVie Announces Positive Results of Study Evaluating SKYRIZI in Plaque Psoriasis Patients AbbVie announced new 52-week data from an open-label, a single-arm study demonstrating improved plaque psoriasis signs and symptoms in a difficult-to-treat patient population who received SKYRIZI® (risankizumab), an IL-23 ...
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Sep 13, 2022
Amgen Announced the Result of its CodeBreak-200 Trial; FDA Clears Bristol-Myers Squibb’s Deucravacitinib; BioNTech’s Amplified CAR-T Therapy; TIL Therapy Improves on Yervoy in Melanoma; GSK’s Daprodustat will have to face FDA Advisory Committee; Breakthrough Therapy Status to Pfizer’s Group B Strep Vaccine; EU Approves Gilead’ Tecartus; Gilead’ Trodelvy Results in TROPiCs-02 Trial
Amgen Reveals the Top-line Result of its CodeBreak-200 trial of Lumakras in Lung Cancer The top-line result of Amgen's CodeBreak-200 trial of Lumakras in lung cancer was presented in abstract form at ESMO two weeks ago, showing a 34% improvement in progression-free survival (PFS) compared to chemotherapy. The fu...
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Aug 02, 2022
Bristol-Myers Squibb’s Opdivo & Yervoy Combo Trial; Sarepta’s Gene Therapy SRP-9001 for DMD; Ionis’s End-Stage Renal Disease Drugs; FDA Approves Arcutis’s Zoryve Cream; Gilead’s Biktarvy for HIV and Hepatitis B; FDA to Review Biogen’s ALS Therapy Tofersen
Bristol-Myers Squibb’s Opdivo and Yervoy Combo Fails in Phase III Trial Bristol-Myers Squibb has reported that their Opdivo and Yervoy checkpoint inhibitor combo failed a phase III trial as adjuvant (post-surgery) therapy for renal cell carcinoma (RCC), the most frequent type of kidney cancer. The CheckMate -914...
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