Bavarian Nordic Submits Supplemental BLA Seeking U.S. FDA Approval of Freeze-Dried Formulation of Smallpox and Mpox Vaccine
By Dr. Matthew Watson
COPENHAGEN, Denmark, May 31, 2024 – Bavarian Nordic A/S (OMX: BAVA) today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of a freeze-dried formulation of JYNNEOS® for prevention of smallpox and mpox disease in adults 18 years of age and older.
Originally posted here:
Bavarian Nordic Submits Supplemental BLA Seeking U.S. FDA Approval of Freeze-Dried Formulation of Smallpox and Mpox Vaccine
Related Post
- Recce Pharmaceuticals Granted Australia Patent for RECCE® Anti-Infectives - November 29th, 2024
- CytomX Therapeutics to Present at the 36th Annual Piper Sandler Healthcare Conference - November 29th, 2024
- Apyx Medical Corporation to Participate in the Piper Sandler 36th Annual Healthcare Conference - November 29th, 2024
- Kane Biotech Announces Change in US Distribution Partner for revyve™ Antimicrobial Wound Gel - November 29th, 2024
- Inozyme Pharma to Participate in the Piper Sandler 36th Annual Healthcare Conference - November 29th, 2024
- PHAXIAM Therapeutics presents an ambitious development strategy to take advantage of the rapidly evolving Phages therapy area - November 29th, 2024
- SELLAS Announces Positive Data from Preclinical Studies Indicating ASXL1 Mutations as Predictor of Response to SLS009 in Solid Cancers - November 29th, 2024
- Coherus Management to Participate in the 2024 Citi Global Healthcare Conference - November 29th, 2024
- Windtree Therapeutics Reports Third Quarter 2024 Financial Results and Provides Key Business Updates - November 29th, 2024
- Revolution Medicines to Host RAS(ON) Inhibitor Clinical Update Webcast on December 2, 2024 - November 29th, 2024
- Sensei Biotherapeutics to Participate in Citi’s 2024 Global Healthcare Conference - November 29th, 2024
- QIAGEN launches novel tools for customizing digital PCR assays and NGS panels for microbial analysis - November 29th, 2024
- Titan Pharmaceuticals, Inc. Announces Receipt of Notice from Nasdaq - November 29th, 2024
- Applied Therapeutics Receives Complete Response Letter from U.S. FDA Regarding New Drug Application for Govorestat for Classic Galactosemia - November 29th, 2024
- Celularity Inc. Announces Receipt of Nasdaq Notification - November 29th, 2024
- HUTCHMED Announces Continued Inclusion of ORPATHYS® (savolitinib) in the National Reimbursement Drug List in China at Current Terms - November 29th, 2024
- Kane Biotech Announces Third Quarter 2024 Financial Results - November 29th, 2024
- Rakovina Therapeutics Announces Private Placement Offering - November 29th, 2024
- MEDSIR, Featured Company at the Shanghai International Medical Oncology Symposium (7th SIMOS) - November 29th, 2024
- Rakovina Therapeutics Announces Increase in Private Placement Offering to $2.5 Million - November 29th, 2024
- Panbela Provides Business Update and Reports Q3 2024 Financial Results - November 15th, 2024
- Scorpius Holdings Reports Third Quarter 2024 Results, Highlighting Strategic Partnerships, Cost Savings, and Progress Toward Profitability - November 15th, 2024
- Plus Therapeutics Reports Third Quarter 2024 Financial Results and Recent Business Highlights - November 15th, 2024
- TFF Pharmaceuticals Announces It Will Wind Down Operations - November 15th, 2024
- Akari Therapeutics Announces Successful Completion of Merger of Akari Therapeutics and Peak Bio - November 15th, 2024
- GRI Bio Reports Third Quarter 2024 Financial Results and Outlines Progress Towards Clinical Data Readout of GRI-0621 in Ongoing Phase 2a Study for... - November 15th, 2024
- Benitec Biopharma Releases First Quarter 2025 Financial Results and Provides Operational Update - November 15th, 2024
- HCW Biologics Reports Third Quarter 2024 Financial Results and Business Highlights - November 15th, 2024
- Lowell Farms Inc. Announces Unaudited Third Quarter 2024 Financial and Operational Results - November 15th, 2024
- Osteal Therapeutics Announces Positive 12-Month Results from the APEX Clinical Trial Program at the 2024 American Association of Hip and Knee Surgeons... - November 15th, 2024
- UPDATE - Tevogen Founder Reflects on Importance of Preserving Shareholder Value While Navigating Growth as it Prepares to File Quarterly Financials - November 15th, 2024
- Avicanna Reports Q3 2024 - November 15th, 2024
- Reviva Reports Third Quarter 2024 Financial Results and Recent Business Highlights - November 15th, 2024
- MediciNova Receives Notice of Allowance from United States Patent and Trademark Office for New Patent Covering MN-001 for Triglyceride Synthesis in... - November 15th, 2024
- Firefly Neuroscience Reports Third Quarter 2024 Results and Provides Stockholder Update - November 15th, 2024
- Dupixent® (dupilumab) sBLA Accepted for FDA Review for the Treatment of Chronic Spontaneous Urticaria (CSU) - November 15th, 2024
- Sandoz receives European Commission approval for Afqlir® (aflibercept), further strengthening leading biosimilar portfolio - November 15th, 2024
- Press Release: Dupixent sBLA accepted for FDA review for the treatment of chronic spontaneous urticaria - November 15th, 2024
- NINER Pharmaceutical Strengthens Global Presence with Strategic IV Fluid Supply Initiative for the U.S. and Latin American Markets - November 15th, 2024
- Bavarian Nordic Announces Interim Results for the First Nine Months of 2024 - November 15th, 2024
- ViaNautis Bio appoints Dr Adi Hoess as Chief Executive Officer - October 21st, 2024
- Phase III trial results of novel triple combination pill for hypertension published in The Lancet - October 21st, 2024
- UPDATE -- Better Choice Company Chairman Issues Letter to Shareholders as Company Continues to Make Progress Towards the Closing of its SRx Health... - October 21st, 2024
- Madrigal Pharmaceuticals to Release Third-Quarter 2024 Financial Results and Host Webcast on October 31, 2024 - October 21st, 2024
- Arcutis Announces Health Canada Approval of ZORYVE® (Roflumilast) Foam 0.3% to Treat Seborrheic Dermatitis in Individuals 9 Years of Age and Older - October 21st, 2024
- Oragenics, Inc. to Present at The Centurion One Capital 2nd Annual Bahamas Summit - October 21st, 2024
- Significant Positive Results from Osteoarthritis Clinical Study in Dogs Treated with Piclidenoson - October 21st, 2024
- Editas Medicine to Host Strategic Update Webinar to Detail Progress Towards 2024 Goals, Including Achievement of Establishing In Vivo Preclinical... - October 21st, 2024
- DBV Technologies to Participate in Upcoming ACAAI 2024 Congress - October 21st, 2024
- Roche’s Vabysmo improved vision in underrepresented populations with diabetic macular edema (DME) in a first-of-its-kind study - October 21st, 2024
- Three-year Results for EYLEA HD® (aflibercept) Injection 8 mg Demonstrate Continued Durable Vision Gains and Anatomic Improvements with Extended... - October 21st, 2024
- Celularity Inc. Receives Notice from Nasdaq; Confirms Intention to File an Appeal - October 21st, 2024
- Tevogen CEO Expresses Gratitude for Unprecedented Public Support of Company’s Business Model of Commercial Success Through Patient Accessibility and... - October 21st, 2024
- NYSE American to Commence Delisting Proceedings with Respect to the Warrants of Calidi Biotherapeutics, Inc. (CLDI WS) - October 21st, 2024
- Nurix Therapeutics Presents Positive Results from the Ongoing Clinical Trial of Its BTK Degrader NX-5948 in Patients with Relapsed/Refractory... - October 21st, 2024
- Angelini Pharma Enters Into An Exclusive Option Agreement With Cureverse to License Global Development and Commercialization Rights For A Novel and... - October 21st, 2024
- Press Release: Sanofi and CD&R partner to fuel Opella’s ambitions in consumer healthcare - October 21st, 2024
- ViaNautis Appoints Ray Jupp as Chief Scientific Officer - October 21st, 2024
- AAVantgarde appoints Ms. Lauren Kaskiel as Chief Business Officer - October 21st, 2024
- Verona Pharma to Report Third Quarter 2024 Financial Results and Provide Corporate Update - October 21st, 2024
- Sagimet Biosciences Announces Publication of Results from Phase 2b FASCINATE-2 Clinical Trial of Denifanstat in Biopsy-Confirmed F2/F3 MASH in The... - October 13th, 2024
- Better Choice Company to Expand into Veterinary Medicine in 2025 Following the Acquisition of SRx Health - October 13th, 2024
- NMD Pharma to Present Data on its Skeletal Muscle Targeted Therapy for Rare Neuromuscular Diseases at the 2024 AANEM Annual Meeting - October 13th, 2024
- Tourmaline Bio to Showcase Two Poster Presentations at the 2024 Cardiometabolic Health Congress - October 13th, 2024
- Alterity Therapeutics Announces Presentation of New Data Describing Neuroprotection of ATH434 at Neuroscience Meeting - October 13th, 2024
- Assertio to Participate in the Maxim Group Healthcare Virtual Summit on October 15, 2024 - October 13th, 2024
- Disc Medicine Announces Presentation of New Data from Phase 1b Trial of DISC-0974 in Patients with Chronic Kidney Disease (CKD) and Anemia at 2024... - October 13th, 2024
- Auron Announces Poster Presentation at 2024 PCF Annual Scientific Retreat - October 13th, 2024
- 23andMe Announces 1-for-20 Reverse Stock Split - October 13th, 2024
- INmune Bio Inc. to Participate in the Maxim Healthcare Virtual Summit - October 13th, 2024
- Firefly Neuroscience to Participate in Upcoming October Investor Conferences - October 13th, 2024
- Capricor Therapeutics Announces Positive Long-Term Data from HOPE-2 OLE Study in Duchenne Muscular Dystrophy at 2024 World Muscle Society Congress - October 13th, 2024
- PacBio Enters Cancer Genomics Research Collaboration in Singapore with Advanced Onso Sequencing - October 13th, 2024
- Vivoryon Therapeutics N.V. Announces Late-breaking Oral Presentation at the American Society of Nephrology Kidney Week 2024 - October 13th, 2024
- Tevogen Bio Extends Pipeline Prioritizing Oncology and Long COVID - October 13th, 2024
- Climb Bio Announces Abstract Selected for Presentation at the American Society of Nephrology Kidney Week 2024 - October 13th, 2024
- Tevogen Bio Plans to Share $1B+ Revenue Potential of its Pipeline Portfolio Beginning Week of October 14, 2024 - October 13th, 2024
- Nurix Therapeutics Reports Third Quarter Fiscal 2024 Financial Results and Provides a Corporate Update - October 13th, 2024
- Quest PharmaTech Announces Results from AGM - October 13th, 2024
- Benitec Biopharma Reports Positive Data from Two Subjects Treated with Low-Dose BB-301 in Phase 1b/2a Study Presented at 29th Annual Congress of the... - October 13th, 2024
Global News Feed
Comments Off on Bavarian Nordic Submits Supplemental BLA Seeking U.S. FDA Approval of Freeze-Dried Formulation of Smallpox and Mpox Vaccine |
June 2nd, 2024
This author published 5872 posts in this site.Share
Comments are closed.
Personalized Gene Medicine
| Mesenchymal Stem Cells
| Stem Cell Treatment for Multiple Sclerosis
| Stem Cell Treatments
| Board Certified Stem Cell Doctors
| Stem Cell Medicine
| Personalized Stem Cells Therapy
| Stem Cell Therapy TV
| Individual Stem Cell Therapy
| Stem Cell Therapy Updates
| MD Supervised Stem Cell Therapy
| IPS Stem Cell Org
| IPS Stem Cell Net
| Genetic Medicine
| Gene Medicine
| Longevity Medicine
| Immortality Medicine
| Nano Medicine
| Gene Therapy MD
| Individual Gene Therapy
| Affordable Stem Cell Therapy
| Affordable Stem Cells
| Stem Cells Research
| Stem Cell Breaking Research