ROCHE: Receives FDA Emergency Use Authorization for new semi-quantitative test to measure the level of SARS-CoV-2 antibodies
Elecsys® Anti-SARS-CoV-2 S test specifically detects antibodies against the SARS-CoV-2 spike protein
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JANSSEN: Submits Application to U.S. FDA Seeking Approval of Amivantamab for the Treatment of Patients with Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
Expanded Access Program Established for Patients in the U.S. Who May Benefit from Investigational Therapy While Application is Under Review
GUERBET LLC USA: US FDA Approves Guerbet's Optiray® (Ioversol Injection) Imaging Bulk Package
Guerbet (GBT), a global leader in medical imaging, announced today that it received US Food and Drug Administration approval for the commercial sale of the Optiray® Imaging Bulk Package (IBP) in the United States, as well as FDA clearance of the LF IBP Transfer Set.
3B MEDICAL: FDA Grants 3B Medical Emergency Use for Lumin UV System Use in Nursing Homes, Ambulatory Care and Primary Care for SARS-CoV-2 N95 Re-Use
3B Medical announced receiving Emergency Use Authorization from the FDA to permit use of Lumin, a UVC system, on N95 respirators during the COVID-19 pandemic.
PRESSURE BIOSCIENCES: Proposed Acquisition Partner Cannaworx, Inc. Announces December 2020 Launch Date for FDA Registered Immune Booster
Designed to Help the Immune System Provide Important Protection Against Invading Pathogens
ENSEMBLE ORTHOPEDICS: Receives FDA Clearance For PyroCarbon CMC Interpositional Implant
Ensemble Orthopedics Inc. today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for its Ensemble CMC Implant. The Ensemble CMC was designed to treat patients with early-stage osteoarthritis of the carpometacarpal (CMC) joint using a minimally invasive, simple surgical procedure.
ACCP: Statement of Support for US FDA: Science & Evidence-based Review and Approval of COVID-19 Vaccines for Use in the US
The COVID-19 pandemic has resulted in an immense number of deaths, disrupted economies worldwide and is a public health emergency.
VOLTA MEDICAL: VX1 AI software for use in atrial fibrillation mapping now FDA cleared
Volta Medical, a pioneering French-based HealthTech startup is pleased to announce that it has obtained FDA clearance for its revolutionary VX1 AI (artificial intelligence) software.
WHOLISTIC PEDIATRICS & FAMILY CARE: Dr. David Berger of Tampa to Address FDA COVID-19 Vaccine Approval Committee Regarding Public Concerns and Hesitations
Dr. David Berger of Wholistic Pediatrics & Family Care presents to the FDA's vaccine approval committee regarding alleviating public concerns and hesitations.
CULTIVATE(MD): Medical Ingenuities Receives FDA 510(k) Clearance for PH Band
Novel radial artery occlusion device removes the guesswork from achieving Patent Hemostasis
VERANTOS: Receives FDA Support to Demonstrate Advanced Approaches to Real-World Evidence
Verantos today announced it has received a grant award from the U.S. Food and Drug Administration (FDA) to implement a multi-year advanced real-world evidence (RWE) study.
FDA: Authorizes First Direct-to-Consumer COVID-19 Test System
Test system is authorized for at-home sample collection with laboratory test processing
FDA: Holds Advisory Committee Meeting to Discuss Authorization of COVID-19 Vaccine Candidate as Part of Agency’s Review of Safety and Effectiveness Data
The following is attributed to FDA Commissioner Stephen M. Hahn, M.D.
FDA: Statement on Vaccines and Related Biological Products Advisory Committee Meeting
The following is attributed to FDA Commissioner Stephen M. Hahn, M.D., and Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.
FDA: Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine
Action Follows Thorough Evaluation of Available Safety, Effectiveness, and Manufacturing Quality Information by FDA Career Scientists, Input from Independent Experts
NSC: National Safety Council Statement on the FDA Advisory Panel Approval of COVID-19 Vaccine and Employers' Subsequent Role
The National Safety Council applauds today's formal recommendation of the Pfizer COVID-19 vaccine and the CDC recommendations that prioritize distributing the vaccine first to healthcare personnel and long-term care facility residents, who need it most urgently.
FDA: Approves First-of-its-Kind Intentional Genomic Alteration in Line of Domestic Pigs for Both Human Food, Potential Therapeutic Uses
Alteration intended to eliminate alpha-gal sugar on surface of pigs’ cells
FARAPULSE: Pivotal Trial to Assess Its Leading Pulsed Field Ablation System for The Treatment of Atrial Fibrillation Receives FDA Conditional Approval
Large, Randomized Controlled ADVENT Trial Designed to Establish New Gold Standard for AF Ablation
MOLECULIN: Announces FDA Permission to Begin Clinical Study of Annamycin for Sarcoma Lung Metastases
Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced that the US Food and Drug Administration (FDA) is allowing the company's Investigational New Drug (IND) application to study Annamycin for the treatment of soft tissue sarcoma lung metastases to go into effect.
KARYOPHARM: Announces FDA Approval of XPOVIO® (Selinexor) as a Treatment for Patients with Multiple Myeloma After At Least One Prior Therapy
Oral XPOVIO Now Available as a Treatment Option for Patients with Multiple Myeloma As Early as First Relapse; Significantly Expands Addressable Patient Population