Alvotech Provides Update on Status of Biologics License Applications for AVT02 and AVT04
By Dr. Matthew Watson
Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the reinspection of Alvotech’s facility in Iceland by the U.S. Food and Drug Administration (FDA) which started on January 10, 2024, has been concluded. Following the FDA inspection, Alvotech received a form 483 with one observation. Alvotech expects to provide the FDA with a response in the following days.
See the article here:
Alvotech Provides Update on Status of Biologics License Applications for AVT02 and AVT04
Related Post
- 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
- Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron KP.2-adapted COVID-19 Vaccine in the European Union - September 23rd, 2024
- Novo Nordisk A/S: Monlunabant phase 2a trial in obesity successfully completed - September 23rd, 2024
- Ipsen’s Iqirvo® (elafibranor) approved in the European Union as first new treatment for primary biliary cholangitis in nearly a decade - September 23rd, 2024
- Firefly Neuroscience Advances AI-Driven BNA™ Technology in Neuroscience Drug Development after Completing Successful Research Collaborations with... - September 23rd, 2024
- T2 Biosystems Achieves Successful Defense of Patent for Direct-From-Whole Blood Pathogen Detection Method in the European Union - September 23rd, 2024
- Qualigen Therapeutics, Inc. Received Extension from Nasdaq Hearings Panel - September 23rd, 2024
- Altamira Therapeutics to Host First Half 2024 Financial Results and Business Update Call on September 24, 2024 - September 23rd, 2024
- Psyence Group Enters into Agreement to Dispose of Stake in PsyLabs - September 23rd, 2024
- Onconetix, Inc. Announces 1-for-40 Reverse Stock Split and Results of the Annual Meeting of Stockholders - September 23rd, 2024
- Sutro Biopharma Announces Inducement Grant Under Nasdaq Listing Rule 5635(c)(4) - September 23rd, 2024
- Universe Pharmaceuticals INC Reports Financial Results for The First Six Months of Fiscal Year 2024 - September 23rd, 2024
- Press Release: Sarclisa approved in the US as the first anti-CD38 therapy in combination with standard-of-care treatment for adult patients with newly... - September 23rd, 2024
- New Data Provide Treatment Insights into Options for Switching Adult Patients Diagnosed with Schizophrenia to UZEDY® (risperidone) Extended-Release... - September 23rd, 2024
- Teva Presents New Phase 3 Efficacy, Safety and Tolerability Data from SOLARIS Trial Evaluating TEV-‘749 (olanzapine) as a Once-Monthly Subcutaneous... - September 23rd, 2024
- Black Diamond Therapeutics to Host Webcast Presentation of Initial Phase 2 BDTX-1535 Data in Patients With Recurrent EGFRm NSCLC - September 23rd, 2024
- WHO endorses dual-stain cytology (CINtec PLUS) testing in its cervical cancer prevention guidelines, advancing patient care and underlining Roche’s... - September 23rd, 2024
- Teva Announces Long Term Efficacy and Safety of Deutetrabenazine in European Patients with Debilitating Movement Disorder Tardive Dyskinesia - September 23rd, 2024
- GENFIT: Ipsen’s Iqirvo® (Elafibranor) Receives EU Approval as a First-in-Class Treatment for Primary Biliary Cholangitis following U.S. FDA... - September 23rd, 2024
- Nicox and Glaukos Sign Exclusive NCX 1728 Research and Global Licensing Option Agreement - September 23rd, 2024
- Synergia Medical Successfully Implants First Patients With NAO.VNS™ - September 23rd, 2024
Global News Feed
Comments Off on Alvotech Provides Update on Status of Biologics License Applications for AVT02 and AVT04 |
January 22nd, 2024
This author published 5852 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