argenx Announces FDA Acceptance of Supplemental Biologics License Application with Priority Review for VYVGART Hytrulo in Chronic Inflammatory…

By adminFebruary 20, 2024Global News Feed

Prescription Drug User Fee Act (PDUFA) target action date is June 21, 2024

See the original post:
argenx Announces FDA Acceptance of Supplemental Biologics License Application with Priority Review for VYVGART Hytrulo in Chronic Inflammatory...

Related Posts

Todos Medical Announces Commercial Launch of Todos Branded COVID-19 qPCR Test Kits in the United States [Last Updated On: September 12th, 2020] [Originally Added On: September 12th, 2020]
Sanofi : Information concerning the total number of voting rights and shares - July 2020 [Last Updated On: September 12th, 2020] [Originally Added On: September 12th, 2020]
Neurocrine Biosciences and Voyager Therapeutics Present New Long-Term Three-Year Data Demonstrating that One-Time Treatment with an Investigational... [Last Updated On: September 12th, 2020] [Originally Added On: September 12th, 2020]
Harrow Health to Attend Lake Street’s Virtual 4th Annual (BIG4) Conference September 17, 2020 [Last Updated On: September 12th, 2020] [Originally Added On: September 12th, 2020]
Novartis presents data at ACTRIMS-ECTRIMS for Kesimpta® (ofatumumab) in newly diagnosed treatment-naïve adults with relapsing multiple sclerosis [Last Updated On: September 12th, 2020] [Originally Added On: September 12th, 2020]
Novartis data show early treatment with Mayzent® (siponimod) delays disability progression and show benefits in cognitive performance in patients... [Last Updated On: September 12th, 2020] [Originally Added On: September 12th, 2020]
Zealand Pharma increases its share capital as a consequence of exercise of employee warrants [Last Updated On: September 12th, 2020] [Originally Added On: September 12th, 2020]
Surface Oncology to Participate in the H.C. Wainwright Global Healthcare Conference [Last Updated On: September 12th, 2020] [Originally Added On: September 12th, 2020]
Artelo Biosciences to Present at the H.C. Wainwright 22nd Annual Global Investment Conference on September 15th [Last Updated On: September 12th, 2020] [Originally Added On: September 12th, 2020]
Adamas presents new post-hoc data analysis for GOCOVRI® in Parkinson’s disease patients with dyskinesia at the 2020 Movement Disorder Society... [Last Updated On: September 12th, 2020] [Originally Added On: September 12th, 2020]
Pfizer and BioNTech Propose Expansion of Pivotal COVID-19 Vaccine Trial [Last Updated On: September 12th, 2020] [Originally Added On: September 12th, 2020]
Axiom Presenting and Exhibiting at SCDM 2020 Virtual Conference September 13-16, 2020 [Last Updated On: September 12th, 2020] [Originally Added On: September 12th, 2020]
Avadel to Present at H.C. Wainwright 22nd Annual Global Investment Conference [Last Updated On: September 12th, 2020] [Originally Added On: September 12th, 2020]
imber Pharmaceuticals to Present at H.C. Wainwright 22nd Annual Global Investment Conference [Last Updated On: September 12th, 2020] [Originally Added On: September 12th, 2020]
AnaptysBio to Present at the 2020 Cantor Global Virtual Healthcare Conference [Last Updated On: September 12th, 2020] [Originally Added On: September 12th, 2020]
Resverlogix Provides Update Regarding Extension of its Filing Calendar [Last Updated On: September 12th, 2020] [Originally Added On: September 12th, 2020]
Timber Pharmaceuticals to Present at H.C. Wainwright 22nd Annual Global Investment Conference [Last Updated On: September 12th, 2020] [Originally Added On: September 12th, 2020]
Adamas Announces New Employment Inducement Grant [Last Updated On: September 12th, 2020] [Originally Added On: September 12th, 2020]
Cassava Sciences to Hold Conference Call on Monday, September 14, 2020 at 8:30 am ET [Last Updated On: September 12th, 2020] [Originally Added On: September 12th, 2020]
Keros Therapeutics Presents Results from Preclinical Studies Investigating KER-012 at the American Society for Bone and Mineral Research 2020 Annual... [Last Updated On: September 12th, 2020] [Originally Added On: September 12th, 2020]
electroCore Provides Business Update and Select Financial Guidance [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
PMV Pharma Granted FDA Fast Track Designation of PC14586 for the Treatment of Advanced Cancer Patients that have Tumors with a p53 Y220C Mutation [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
Arbutus to Participate in Virtual Fireside Chat at H.C. Wainwright Hepatitis B Virus (HBV) Mini-Conference [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
Novavax Appoints Leadership Team to Advance NanoFlu through Regulatory Licensure [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
STEM Animal Health Appoints New President and CEO [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
GenMark Diagnostics Provides Preliminary Financial Results for Third Quarter 2020 [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
Indus Holdings, Inc. Pre-Announces Record Q3 2020 Revenues in Excess of $14 Million, ~15% EBITDA Margins, and Positive Operating Income [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
Todos Medical Reports $2.0 Million in Revenue for the Third Quarter of 2020 [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
Monthly information regarding the total number of voting rights and total number of shares of the Company as of September 30, 2020 [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
Telo Genomics Announces that Positive Results of Smoldering Multiple Myeloma Study Selected for Online Publication Within ASH 2020 Proceedings [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
Motus GI Hosting Key Opinion Leader Call on Improving Endoscopy Outcomes with the Pure-Vu® System [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
Stabilization measures taken [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
Better Choice Announces Closing of Expanded Series F Financing and Acceleration of Asian Expansion [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
CohBar’s CEO to Participate on the Emerging Companies Panel at the Targeting Metabesity Conference [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
Abeona Therapeutics’ Board of Directors Forms Special Committee to Oversee Operations, Develop Strategic Direction and Leadership Plan [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
Acacia Pharma announces BYFAVO™ (remimazolam), its Newly Approved Product for Procedural Sedation, Clears Final Hurdle on Path to Commercial Launch... [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
Tauriga Sciences Inc. Officially Approved to Operate as a U.S. Government Vendor [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
Arcutis Biotherapeutics Announces Closing of Public Offering and Concurrent Private Placement of Common Stock [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
SetPoint Medical Receives FDA Breakthrough Device Designation for its Novel Bioelectronic Platform [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
Tauriga Sciences Inc. Secures $135,000 in Inventory Factoring Capital to Support its Accelerating Revenue Growth [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
Derm-Biome Pharmaceuticals, Inc. Reports Positive Results from a Preclinical Study In Psoriasis [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
GenMark Diagnostics’ ePlex® Respiratory Pathogen Panel 2 (RP2) Receives EUA from FDA [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
Enzo Biochem to Report Fourth Quarter and Fiscal Year 2020 Financial Results on Tuesday, October 13 [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
Outlook Therapeutics Announces Initiation of Supplemental Open-Label Safety Study for ONS-5010 / LYTENAVA™ (bevacizumab-vikg) [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
Caladrius Biosciences Opens Study of CLBS119 to Repair COVID-19-Induced Lung Damage [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
XORTX Receives Positive Feedback from FDA on COVID-19 Related Acute Kidney Injury [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
Mustang Bio Announces MB-105 Data Selected for Presentation at the Virtual 27th Annual Prostate Cancer Foundation Scientific Retreat [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
Syneos Health Wins Society for Clinical Research Sites Eagle Award for Fourth Consecutive Year [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
Zynerba Pharmaceuticals Announces the Acceptance of Two Posters at the Virtual Joint 49th Annual Child Neurology Society & 16th International... [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
Celldex Therapeutics Initiates Phase 1b Study of CDX-0159 in Chronic Spontaneous Urticaria [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
Selecta Biosciences and IGAN Biosciences Enter into Research License and Option Agreement to Study Selecta’s ImmTOR™ Immune Tolerance Platform in... [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
BioCorRx Partners with Truusight Health to Integrate Recovery Program Into Self-Funded Health Plans [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
Susan Hirsch Joins Agenus’ Board of Directors [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
C4 Therapeutics Announces Closing of Initial Public Offering and Full Exercise of the Underwriters’ Option to Purchase Additional Shares [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
Eton Pharmaceuticals Announces Acceptance for Filing of New Drug Application for Orphan Drug Dehydrated Alcohol Injection [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
Larimar Therapeutics Announces Formation of Scientific Advisory Board [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
PCI Biotech: Employee share option scheme [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
Rafarma Approves Issuance of Majority of Voting Shares to Board Chairman Ilya Shpurov [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
American Gene Technologies to Present at 2020 Virtual Cell & Gene Meeting on the Mesa [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
Zynerba Pharmaceuticals Announces Oral Presentations at the Virtual American Academy of Child and Adolescent Psychiatry (AACAP) 2020 Annual Meeting [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
Generex Subsidiary NuGenerex Immuno-Oncology Announces Publication of a Review Article on Cancer Vaccines Highlighting AE37 (Ii-Key-HER2)... [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
Auris Medical Announces Initiation of Part B of TRAVERS Phase 2 Study with AM-125 in Vertigo [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
AnaptysBio Reports Positive Topline Data from GALLOP Phase 2 Clinical Trial of Imsidolimab in Moderate-to-Severe Generalized Pustular Psoriasis (GPP) [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
Recent Peer-Reviewed Publication Supports Immunotherapy for the Treatment of Food Allergies [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
Aligos Therapeutics Presents Coronavirus Therapeutic Screening Assay Development at ISIRV-AVG Conference [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
FibroGenesis Named Top 20 Most Innovative Companies of 2020 and Lands at the #2 Spot on Global Smart Leaders Magazine List [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
Catalyst Pharmaceuticals Announces Issuance of U.S. Patent for Firdapse® [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
Oyster Point Pharma Announces Board of Directors Leadership Changes and New Appointment as the Company Advances into Next Phase of Growth [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
Novo Nordisk raises sales and operating profit outlook for 2020 [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
X4 Pharmaceuticals Announces Fast Track Designation Granted by the FDA to Mavorixafor for the Treatment of WHIM Syndrome [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
Enlivex: After Expedited Review, Israeli Ministry of Health Authorizes Initiation of Phase II Clinical Trial Evaluating Allocetra in COVID-19 Severe... [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
CorMedix to Participate in BIO Investor Forum Digital [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
Eton Pharmaceuticals Submits New Drug Application to the FDA for Topiramate Oral Solution (ET-101) [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
PRA Health Sciences selected by BARDA to be a member of its exclusive Clinical Studies Network [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
SpringWorks Therapeutics Announces Proposed Public Offering of Common Stock [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
VYNE Therapeutics Announces ZILXI™ (minocycline) topical foam, 1.5% is Available in Pharmacies Nationwide Today, October 1st [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
CytomX Therapeutics Announces the Planned Retirement of Chief Scientific Officer, W. Michael Kavanaugh, M.D. [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
Hyloris appoints Dr. Dietmar Aichhorn as Chief Operating Officer [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
Caladrius Biosciences to Present at the BIO Investor Forum Digital [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]
Athira Pharma Announces Initiation of Patient Dosing for the LIFT-AD Study, a Phase 2/3 Clinical Trial to Evaluate ATH-1017 for Treatment of... [Last Updated On: October 17th, 2020] [Originally Added On: October 17th, 2020]