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Immunological and Autoimmune Disorders

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Notizia - Recent Pharma, Healthcare and Biotech Happenings

FDA Approves Ascendis Pharma’s YORVIPATH; ARS Pharma Gets FDA Green Light for First Nasal Spray; FDA Rejects Lykos’ MDMA-Assisted PTSD Therapy; Novartis’ FABHALTA Receives FDA Accelerated Approval; Servier Snags FDA Approval for Voranigo

Ascendis Pharma Lands Long-Awaited FDA Drug Approval in Rare Hormone Deficiency Ascendis Pharma A/S has announced that the FDA has approved YORVIPATH (palopegteriparatide; developed as TransCon PTH) for the treatment of hypoparathyroidism in adults. YORVIPATH, a prodrug of parathyroid hormone (PTH[1-34]), is administered once daily and designed to provide continuous exposure to PTH over a 24-hour period. Hypoparathyroidism, affecting an estimated ~270K people in the 7MM, is a rare endocrine disease caused by insufficient levels of parathyroid hormone. Jan Mikkelsen, Ascendis Pharma’s President and CEO, expressed gratitude for the approval, stating, “FDA approva...

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Pharma News for GSK, Sanofi, Biogen, Artiva

Survodutide Phase II trial Shows Groundbreaking Results in Liver Disease; GSK Announces Positive Headline Results from EAGLE-1 Phase III Trial; Dupixent sBLA Accepted for FDA Priority Review; Biogen’s QALSODY Received Positive Opinion from CHMP; FDA Granted Orphan Drug Designation to Immune-Onc’s IO-202; Artiva Biotherapeutics’s AlloNK® in Lupus Nephritis

Pharma News for Novartis, Iovance, Certa, Innovent

FDA Approves Xolair for Food Allergies; FDA Accelerated Approval for Iovance’s AMTAGVI; Astellas and Kelonia Enter into Research and License Agreement; Fast Track Designation to Certa’s FT011; Innovent Announces Phase 3 Clinical Trial Updates for IBI311; Orphan Drug Designation to Cardiol’s Pericarditis Drug Candidate

Pressure Relief Devices Market Analysis

Pressure Relief Devices: Charting the Course of Market Evolution and Major Developments

Navigating the Healthcare Horizon: Odyssey of Mergers, Funding, and Acquisitions in 2024

Pharma News For Astellas, AnaMar, Biosyngen

4DMT Presents Data From Phase II PRISM Clinical Trial; Adaptimmune Announces FDA Acceptance of Biologics License Application for Afami-cel; Astellas Submits Supplemental New Drug Application in Japan for PADCEV with KEYTRUDA; AnaMar Announces US and EU Orphan Drug Designation for AM1476; Biosyngen Announces FDA Fast Track Designation for BST02; Acepodia Announces FDA Clearance of IND Application for ACE2016

A Glance at Key Insights From 42nd J.P. Morgan Annual Healthcare Conclave

Pharma News for Merck, AbbVie, Abbisko

Merck to Acquire Harpoon Therapeutics; Novo Nordisk Enters Into Collaborations with Omega Therapeutics and Cellarity; AbbVie’s Lutikizumab’s Phase II Trial Result for Hidradenitis Suppurativa; Abbisko’s CSF-1R Inhibitor Pimicotinib (ABSK021); Cabaletta Bio’s CABA-201; FDA Grants Fast Track” Designation for Soligenix’s Dusquetide

Pharma News for Eisai, Biogen, Merck, BMS, Kyverna

Eisai Submits Marketing Authorization Application for Tasurgratinib; CHMP Issues Positive Opinion for Biogen’s SKYCLARYS; European Commission Approves Merck’s KEYTRUDA + Chemotherapy HER2-ve Gastric or GEJ Adenocarcinoma; BMS Provides Update on RELATIVITY-123 Trial; Kyverna Therapeutics Granted FDA Fast Track Designation for KYV-101; Verrica and Torii Pharma Announces Positive Top-line Results from a Confirmatory Phase 3 Trial of TO-208

Implantable Drug Delivery Devices Market Outlook

Assessing the Emerging Trends in the Evolving Implantable Drug Delivery Device Landscape

stelara-biosimilar-wezlana

Could Amgen’s Biosimilar Wezlana Pose a Challenge to Johnson & Johnson’s Stelara

Pharma News for Sanofi, Sosei, AstraZeneca, Arcturus

Dupixent Significantly Reduced COPD Exacerbations; Sosei Heptares to Regain Ownership of GSK4381406; AstraZeneca Gains Rights to Usynova’s KRAS Inhibitor; FDA Approvs OGSIVEO for Desmoid Tumors; Orphan Drug Designation for ARCT-032 for the Cystic Fibrosis; FDA Fast Track Designation for ADP101 for Food Allergies

Pharma News for Takeda, AskBio, Bayer, Lipella

Takeda’s ADZYNMA Approved by FDA; AskBio Presents Preliminary Data from Phase I Trial of Gene Therapy for CHF; Bayer’s Aflibercept 8 mg Recommended for Approval in EU; FDA Orphan Drug Designation to MAIA Biotechnology’s THIO; First Patient Dosed in Phase III ProstACT GLOBAL Study; FDA Grants Orphan Designation for Lipella’s LP-310 Drug Candidate

Pharma News for Pfizer, UCB, BioMarin

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

Allergy Diagnostics Market Trends

Allergy Diagnostics: Unraveling the Science, Market Trends, and Future Prospects

Immunomodulators Market and Key Applications

Harnessing the Power of Immunomodulators: Applications and Implications

Pharma News for Amgen, Anaptys, Sanofi, Boehringer

Amgen to Acquire Horizon Therapeutics; Sanofi and Teva Announce Collaboration; Boehringer Obesity Drug Trial Update; FDA Places Partial Clinical Hold on IND for Lacutamab in CTCL/PTCL; Anaptys Announces Phase 3 Clinical Trial Results of Imsidolimab; Orphan Drug Designation to GC Biopharma’s GC1126A

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