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Notizia - Recent Pharma, Healthcare and Biotech Happenings

FDA Approves Sanofi/Regeneron’s DUPIXENT as First New CSU Therapy in Over a Decade; Gilead’s TRODELVY + KEYTRUDA Shows PFS Benefit in PD-L1+ TNBC; Tempest’s TPST-1495 Gets FDA Orphan Tag for FAP; uniQure’s AMT-130 Granted FDA Breakthrough for Huntington’s; NeuroNOS’ BA-102 Secures FDA Orphan Status for Phelan-McDermid Syndrome

FDA Approves Sanofi/Regeneron’s DUPIXENT as First New Targeted Therapy in Over a Decade for Chronic Spontaneous Urticaria Regeneron Pharmaceuticals and Sanofi have announced that the FDA has approved DUPIXENT (dupilumab) for the treatment of adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite treatment with histamine-1 (H1) antihistamines. This approval marks the first new targeted therapy for CSU in over a decade. The decision is based on the results of two Phase III trials, which showed that DUPIXENT significantly reduced itch severity and urticaria activity when used in combination with antihista...

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Neurotech’s ENCELTO Becomes First FDA-Approved Treatment for MacTel Type 2; Plus Therapeutics’ Rhenium Obisbemeda Gets FDA Orphan Status; Novo Nordisk Cuts WEGOVY to $499/Month; Capricor’s Deramiocel Wins FDA Priority Review; Celltrion’s OMLYCLO Becomes First Interchangeable XOLAIR Biosimilar

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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

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FDA Approves Vertex’s ALYFTREK for Cystic Fibrosis; ZEPBOUND Gets FDA Approval for Obstructive Sleep Apnea in Obese Adults; Tonix’s TNX-102 SL NDA Accepted for Fibromyalgia; Quoin’s QRX003 Clears FDA for Netherton Syndrome Study; FDA Approves First Mesenchymal Stromal Cell Therapy for Acute GvHD

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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.

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FDA Approves PTC’s AADC Gene Therapy; DUPIXENT sBLA Acceptance for Urticaria; CHMP Recommends TAGRISSO for EGFR Lung Cancer; FDA Approves DANZITEN for CML; Syndax Wins FDA Approval for REVUFORJ in Acute Leukemia

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5 Promising Exosome-based Therapies Paving the Way for Personalized Medicine

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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

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7 Hidradenitis Suppurativa Drugs Set to Hit the Market in the Next 5 Years

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Could Hidradenitis Suppurativa Be Another Psoriasis?

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IMFINZI’s AEGEAN Phase III Trial Data for Treating Resectable NSCLC; Ipsen and Day One’s Exclusive Agreement to License and Market Tovorafenib Outside the US; Alzheimer’s Drug LEQUEMBI Rejected by EU; EU Apporves Pfizer’s Gene Therapy DURVEQTIX; CHMP Approves SPEVIGO’s New Indications

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STRATA Skin Sciences’ XTRAC Momentum™ 1.0 Device Approved in Japan; eCential Robotics Received FDA 510(k) Clearance for Spine Navigation and Robotic-Assistance Device; MicroVention Announced the Results of the Clinical Evaluation of WEB™ 17 Device; Neuspera Medical, Inc.’s SANS-UUI Pivotal Clinical Trial; GE HealthCare Announced an Agreement to Acquire the Clinical Artificial Intelligence Business; Sutter Health Implemented World’s First Wearable Doppler Ultrasound Patch

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ZORYVE for Atopic Dermatitis Treatment: Is the Breakthrough We’ve Been Waiting for?

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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

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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

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Atopic Dermatitis Treatment: Rich Portfolio of Therapeutic Options Shaping the Future

Latest Developments in the US Psoriasis Treatment Market

Revolutionizing Psoriasis Treatment: Advancements in the US Market

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