ILLUMINOSS MEDICAL: Receives FDA Clearance for Expanded Clinical Use for Pelvic, Clavicle and Small-Bone Fractures
The new indication expansion significantly broadens the opportunities to address the geriatric fragility fracture market
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FDA: Coronavirus (COVID-19) Update: FDA Issues Warning Letters to Companies Inappropriately Marketing Antibody Tests, Potentially Placing Public Health at Risk
Agency Continues Effort to Help Protect Public Health from Fraudulent Products
FDA: Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Chembio Antibody Test
The U.S. Food and Drug Administration revoked the emergency use authorization (EUA) of the Chembio Diagnostic System, Inc. (Chembio) DPP COVID-19 IgM/IgG System, a SARS-CoV-2 antibody test, due to performance concerns with the accuracy of the test.
CURIS: Announces FDA Clearance of IND Application for CI-8993, the First-In-Class Monoclonal Anti-VISTA Antibody
Phase 1a/1b dose escalation study to begin in the second half of 2020
CELLENKOS® INC.: Announces FDA Clearance to Initiate Phase 1 Double- Blinded, Randomized, Placebo-Controlled Trial of Cryopreserved Cord Blood-Derived T-Regulatory Cells (CK0802) for Treatment of COVID-19 Associated Acute Respiratory Distress Syndrome
Cellenkos Inc., a privately held, clinical stage biotech company announced today that the US Food & Drug Administration (FDA) has cleared the way to initiate a Phase 1 clinical trial of CK0802 (Cryopreserved Cord Blood Derived T-Regulatory Cells) for treatment of COVID-19 associated acute respiratory distress syndrome (ARDS).
FDA: Coronavirus (COVID-19) Update: FDA Takes Action to Protect Public Health; Increase Supply of Alcohol-Based Hand Sanitizer
The FDA has taken additional action to help ensure widespread access to hand sanitizers during the COVID-19 public health emergency.
CYTRX CORPORATION: Highlights Orphazyme's Receipt of FDA Fast Track Designation for the Development of Arimoclomol in Amyotrophic Lateral Sclerosis (ALS)
CytRx Corporation (OTCQB: CYTR), a biopharmaceutical research and development company specializing principally in oncology and neurodegenerative diseases, today highlighted that Orphayzme A/S announced they have received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the development of arimoclomol for the treatment of amyotrophic lateral sclerosis (ALS).
TRINETX: TriNetX & Harvard Pilgrim Health Care Institute Partner on FDA Sentinel System to Monitor COVID-19 Drug Usage
COVID-19 Clinical Real-World Data Being Utilized to Monitor for Potential Drug Shortages
AUTOMATED MARKING INCORPORATED: Solutions For The New FDA Mandated COVID-19 Supply Chain Requirements
Marking, Coding, and Packaging Products are a Key Part of the Critical Supply Chain Overhaul
G MEDICAL INNOVATIONS: VSMS ECG Patch receives US FDA 'Emergency Use Authorisation' for patients being treated for COVID-19
Patch now authorised in the USA for emergency use for patients undergoing treatment for COVID-19
FDA: USDA, FDA Strengthen U.S. Food Supply Chain Protections
The following statement is attributed to Mindy Brashears, Ph.D., USDA Under Secretary for Food Safety, and Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response
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FDA: Issues warning letters to two breast implant manufacturers as part of ongoing efforts to protect patients
Allergan cited for failure to comply with post-approval study requirements; Ideal Implant Inc. cited for failures relating to quality system and medical device reporting regulations
ICOMETRIX: FDA permits use of icometrix's AI-based quantification for chest CT in COVID-19
icometrix announced today that the FDA has allowed the clinical use of their icolung AI algorithms for fast and objective quantification of lung pathology on chest CT scans in admitted COVID-19 patients.
FDA: Coronavirus (COVID-19) Update: FDA Takes New Actions to Accelerate Development of Novel Prevention, Treatment Options for COVID-19
The U.S. Food and Drug Administration took important actions to help accelerate the development of prevention and treatment options for COVID-19 by providing new guidance with recommendations for innovators and researchers conducting work in this area.
FDA: Coronavirus (COVID-19) Update: FDA Authorizes First Diagnostic Test Using At-Home Collection of Saliva Specimens
U.S. Food and Drug Administration authorized the first diagnostic test with the option of using home-collected saliva samples for COVID-19 testing.
BEXION PHARMACEUTICALS: Receives Orphan Drug Designation for BXQ-350 for Malignant Glioma from FDA
Bexion Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted the company Orphan Drug Designation for its proprietary drug, BXQ-350, for the treatment of malignant glioma, including diffuse intrinsic pontine glioma (DIPG).
BIO-RAD: Bio-Rad’s SARS-CoV-2 (COVID-19) Serology Test Granted FDA Emergency Use Authorization, the First Total Antibody Test to Receive EUA from the FDA
Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb), a global leader of life science research and clinical diagnostic products, today announced that it was granted U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for the company’s SARS-CoV-2 Total Ab test, the first total antibody test receiving EUA from the FDA.