Tentative approval will help enhance access to WHO-recommended pediatric medicine and reduce the cost of HIV treatment for children in low- and middle-income countries
Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced that the New Drug Application (NDA) was resubmitted to the U.S. Food and Drug Administration (FDA) for HTX-011, an investigational agent for the management of postoperative pain.
FDA strongly endorsed diversity in clinical trials as central to good science and drug safety." said Dr. Jane L. Delgado, PhD, MS, President and CEO of the National Alliance for Hispanic Health, the nation's leading Hispanic health advocacy group. "Now responsibility for making it happen is with clinical trial sponsors and FDA review boards. The guidance must be a part of any future COVID-19 vaccine or drug approval."
PDUFA date extended by FDA from March 5, 2021 to June 5, 2021
As the weather gets cooler, you may find yourself wanting to spend more time baking or cooking in your kitchen or sipping a cup of cider. What better way to get cozy this fall than with a warm treat? To help you safely bake, cook, and enjoy your cider this season, the U.S. Food and Drug Administration (FDA) offers food safety tips that can help you avoid foodborne illness (also known as food poisoning).
As the U.S. Food and Drug Administration continues our work to address the current pandemic, we are also looking ahead to prepare for the next potential public health emergency.
In three pivotal Phase 3 studies, RINVOQ met co-primary and all secondary endpoints in adult and adolescent patients with moderate to severe atopic dermatitis
Embody, Inc., a privately-held medical device company developing novel collagen-based technologies for sports medicine and soft tissue repair, announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its TAPESTRY Biointegrative Implant for tendon and ligament repair.
EpiVax and CUBRC announce $1.1M contract award from the OGD in CDER of the FDA in response to FDA BAA-20-00123.
Subsequent clinical trials expected to commence in 2020
Final Rule, Guidance Fulfill Plan for Safe Importation of Certain Drugs Originally Intended for Foreign Markets
U.S. Food and Drug Administration announced it is launching the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH).
The FDA has proposed a new rule that lays the foundation for the end-to-end food traceability across the food industry that we’ll be working toward over the next decade as part of the New Era of Smarter Food Safety initiative.
September is National Food Safety Education Month and it's the perfect time to learn the key steps for food safety: Clean, Separate, Cook and Chill.
Clover's technology-first approach brings a new perspective to group of legacy payors
Novel technology defines new product category for accessible, cost-effective point-of-care magnetic resonance imaging.
Enzychem Lifesciences (KOSDAQ: 183490) announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug Application (IND) to evaluate its lead therapeutic candidate EC-18, in a Phase 2 clinical trial in patients with Acute Respiratory Disease Syndrome (ARDS) due to COVID-19 pneumonia. A Phase 2 study for EC-18 in Preventing ARDS due to novel coronavirus pneumonia is currently ongoing in South Korea.