Atopic dermatitis
Jun 24, 2025
Incyte’s MONJUVI Combo Approved by FDA for Relapsed/Refractory Follicular Lymphoma; Gilead’s YEZTUGO Becomes First FDA-Approved HIV Prevention with 6-Month Protection; FDA Reviewing Incyte’s OPZELURA for Pediatric Atopic Dermatitis (Ages 2–11); Archeus Technologies Receives FDA Clearance for Prostate Cancer Therapy ART-101; Cycle Pharmaceuticals’ HARLIKU Gets First FDA Approval for Alkaptonuria
Incyte’s MONJUVI Combo Approved by FDA for Relapsed/Refractory Follicular Lymphoma Incyte has announced that the FDA has approved MONJUVI (tafasitamab-cxix) in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). This makes it the f...
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Feb 18, 2025
EU Approves Galderma’s NEMLUVIO for Atopic Dermatitis and Prurigo Nodularis; GSK’s Penmenvy Wins FDA Nod; Ono Pharmaceuticals’ ROMVIMZA Gets Green Light from FDA for Symptomatic TGCT; Bristol Myers Squibb Updates on RELATIVITY-098 Phase III Trial Findings; FDA Expands Label for Astellas’ IZERVAY in Geographic Atrophy Treatment
EU Approves Galderma’s NEMLUVIO for Atopic Dermatitis and Prurigo Nodularis Galderma has announced that the European Commission has approved NEMLUVIO in the European Union (EU) to treat both moderate-to-severe atopic dermatitis and prurigo nodularis. The approval allows Nemluvio to be used subcutaneously for pat...
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Dec 30, 2024
6 Emerging Treg Cell-based Therapies Shaping the Future of Immunotherapy
Treg (regulatory T-cell) therapies utilize the immunosuppressive abilities of regulatory T-cells to address various conditions, such as autoimmune diseases, inflammatory disorders, and transplant rejection. These treatments take advantage of Tregs’ natural role in maintaining immune balance by suppressing overactiv...
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Dec 17, 2024
FDA Approves Neurocrine’s CRENESSITY for Congenital Adrenal Hyperplasia; Checkpoint’s UNLOXCYT Approved; MAIA’s THIO Gets Rare Pediatric Disease Designation; JEMPERLI Receives Breakthrough Therapy for Rectal Cancer; Galderma’s NEMLUVIO Approved for Atopic Dermatitis.
Neurocrine Announces FDA Approval of CRENESSITY for Congenital Adrenal Hyperplasia Neurocrine Biosciences, Inc. announced that the FDA has approved CRENESSITY™ (crinecerfont) as an adjunctive treatment to glucocorticoid replacement for controlling androgens in adult and pediatric patients aged four years and old...
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Oct 25, 2024
5 Promising Exosome-based Therapies Paving the Way for Personalized Medicine
Exosome therapies represent an exciting frontier in the development of novel treatments for a wide range of diseases. The ability to harness the natural communication system of cells offers unparalleled potential for precise and effective treatments. While challenges remain, ongoing research and technological advan...
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Oct 07, 2024
DUPIXENT Receives First-Ever Biologic Approval for COPD: Adds Another Jewel in its Crown
After more than ten years without significant therapeutic advancements in chronic obstructive pulmonary disease (COPD), patients with this progressive condition now have two new treatment options, with more likely to follow. Regeneron and Sanofi recently announced that the FDA has broadened the use of the highly...
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Sep 17, 2024
Johnson & Johnson’s TREMFYA Approved for Ulcerative Colitis; Roche’s Tecentriq Hybreza Approved as Subcutaneous Anti-PD-(L)1; OCREVUS ZUNOVO Receives Twice-a-Year Multiple Sclerosis Injection Approval; Lilly’s EBGLYSS Greenlit for Moderate-to-Severe Atopic Dermatitis; DUPIXENT Approved for Adolescents with Chronic Rhinosinusitis
TREMFYA Approved for Moderately to Severely Active Ulcerative Colitis Johnson & Johnson announced that the FDA has approved TREMFYA (guselkumab) for treating adults with moderately to severely active ulcerative colitis. TREMFYA is the first fully human, dual-acting monoclonal antibody that blocks IL-23 and b...
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Jul 19, 2024
ZORYVE for Atopic Dermatitis Treatment: Is the Breakthrough We’ve Been Waiting for?
After a few days of investor anxiety, Arcutis Biotherapeutics announced that the FDA has approved ZORYVE for a new indication: atopic dermatitis. The FDA was scheduled to announce its decision on ZORYVE (roflumilast) for this new use on the 7th of this month, but the date passed without news. In an uncommon move to...
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Jul 16, 2024
Immutep’ First-Line Treatment Positive Outcomes; Pfizer’s Once-Daily Oral GLP-1 Agonist Danuglipron; FDA Issues Complete Response Letter to Novo Nordisk; Arcutis’ ZORYVE® Cream 0.15% FDA Approval; NICE Recommends Ebglyss For Moderate To Severe Atopic Dermatitis
Immutep Announces Promising Outcomes for First-Line Treatment in PD-L1 Negative Head and Neck Squamous Cell Carcinoma Patients Immutep Limited announced positive results from Cohort B of the TACTI-003 (KEYNOTE-PNC-34) Phase IIb trial, evaluating eftilagimod alfa (efti) combined with MSD’s anti-PD-1 therapy KEYTR...
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May 21, 2024
Amgen’s IMDELLTRA FDA Approval; J&J’s Proteologix Acquisition; Bristol Myers Squibb’s BREYANZI FDA Approval; AbbVie and Gilgamesh Pharmaceuticals’ Agreement; Eisai’s LEQEMBI FDA Fast Track Status
IMDELLTRA Receives FDA Approval as the First T-Cell Engager Therapy for Advanced Small Cell Lung Cancer Amgen has reported that the FDA has approved IMDELLTRA™ (tarlatamab-dlle) for treating adult patients with extensive-stage small cell lung cancer (ES-SCLC) who have experienced disease progression following pl...
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