2nd Investigational Gene Therapy in Clinic, Potential 3rd Therapy in PKU Franchise, 15+ Year Commitment to PKU Community
BD FACSDuet™ Sample Preparation System, now available in the U.S., as the first fully automated sample-to-answer solution when integrated with the BD FACSLyric™ Flow Cytometer
Haemonetics Corporation (NYSE: HAE), a global medical technology company focused on delivering innovative hematology solutions to drive better patient outcomes, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its NexSys PCS® system with Persona™ technology.
Ajinomoto Bio-Pharma Services ("Aji Bio-Pharma"), a leading provider of biopharmaceutical contract development and manufacturing services, is pleased to announce that the US FDA has approved the first commercial drug manufactured via Aji Bio-Pharma's proprietary AJIPHASE® production process.
Automated, dual antigen serological testing for SARS-CoV-2 IgG antibodies now EUA approved and ready to ship!
WAKIX is the first and only non-scheduled treatment approved for excessive daytime sleepiness or cataplexy in adult patients with narcolepsy
World's Simplest High Throughput RT-PCR Test for COVID-19 has the potential to increase testing capacity by millions per week
RLF-100™ therapy associated with a 9-fold increased probability of survival and recovery from respiratory failure in an open-label, prospective study
First compound from pipeline of six early-stage oncology programs to advance into clinical development-
Alkermes plc (Nasdaq: ALKS) announced positive voting outcomes from the joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, appointed by the U.S. Food and Drug Administration (FDA).
Personalized digital surgery platform can simulate surgery and print 3D surgical splints and guides for the operating room
Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO) today announces that the Company has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA), for OPD5 - a second drug candidate based on the proprietary Peptide Drug Conjugate platform (PDC).
Fresenius Medical Care North America Announces Next Generation Solution Bags to Support Continued Home Dialysis Expansion
Ezra's Prostate AI is the first to ever be cleared by the FDA for prostate and lesion segmentation using AI
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas" ) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of ASP0367/MA-0211 ("ASP0367") as a potential treatment for primary mitochondrial myopathies (PMM).
Comprehensive portfolio is the first of several planned plating releases for the distal extremities
This is the company's 6th FDA clearance and further solidifies its leadership as the most comprehensive acute AI vendor in the market
Cannabics Pharmaceuticals Inc. recently issued the following announcement.Cannabics Pharmaceuticals Inc. (OTCQB: CNBX), a global leader in the development of cancer related cannabinoid-based therapeutic formulations and medicines, announced today that it has signed an agreement with a leading clinical quality and validation processes consultancy to oversee the preparation and submission of a Pre-IND Meeting request to the FDA on its anti-tumor Drug Candidate CANNABICS™ RCC-33, the world's first cannabinoid-based antitumor Drug Candidate for the treatment of Colorectal Cancer.
Dr. David Berger of Wholistic Pediatrics & Family Care comments on FDA's actions concerning public input on COVID-19 vaccine
The First Ever Solution to Enable Digitization and Analysis of Full Field Peripheral Blood Smears with Decision Support System (DSS) Tailored to Augment Hematology Diagnostics