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FDA approves first companion diagnostic that uses liquid biopsy and NGS technology

Today, the U.S. Food and Drug Administration approved the first liquid biopsy companion diagnostic that also uses next-generation sequencing (NGS) technology to identify patients with specific types of mutations of the epidermal growth factor receptor (EGFR) gene in a deadly form of metastatic non-small cell lung cancer (NSCLC).

7 Aug 2020

FDA approves first oral drug for treatment of spinal muscular atrophy

The U.S. Food and Drug Administration today approved Evrysdi (risdiplam) to treat patients two months of age and older with spinal muscular atrophy (SMA), a rare and often fatal genetic disease affecting muscle strength and movement.

7 Aug 2020

OU Health Sciences Center awarded five-year grant for suicide prevention

The University of Oklahoma Health Sciences Center has been awarded a five-year, $38 million grant to lead and expand a national program dedicated to suicide prevention.

6 Aug 2020

Carefully engineered spike protein can help develop COVID-19 vaccine

The experimental vaccine against SARS-CoV-2 that was the first to enter human trials in the United States has been shown to elicit neutralizing antibodies and a helpful T-cell response with the aid of a carefully engineered spike protein that mimics the infection-spreading part of the virus.

6 Aug 2020

Hospital mobility programs can improve outcomes in older patients

A paper published today in the Journal of the American Geriatrics Society reported results of an initiative designed to enhance implementation of hospital mobility programs aimed at improving quality of care and outcomes for older patients.

6 Aug 2020

NIH-Moderna investigational vaccine protects mice from infection with SARS-CoV-2

The investigational vaccine known as mRNA-1273 protected mice from infection with SARS-CoV-2, the virus that causes COVID-19, according to research published today in Nature.

5 Aug 2020

NIH harnesses artificial intelligence and medical imaging to fight COVID-19

The National Institutes of Health has launched the Medical Imaging and Data Resource Center, an ambitious effort that will harness the powers of artificial intelligence, and medical imaging to fight COVID-19.

5 Aug 2020

Could labs that test livestock ease covid testing backlog for people? Well … maybe.

In a heated exchange late last month on CNN's State of the Union, host Jake Tapper pressed Adm. Brett Giroir, the Health and Human Services assistant secretary who oversees COVID testing efforts for the Trump administration, on why the government isn't requiring commercial labs to increase testing capacity in order to speed turnaround time.

5 Aug 2020

NIH trial to evaluate potential new therapeutics for mild, moderate COVID-19

A Phase 2 clinical trial will evaluate the safety and efficacy of potential new therapeutics for COVID-19, including an investigational therapeutic based on synthetic monoclonal antibodies (mAbs) to treat the disease.

4 Aug 2020

Clinical trial to test safety, efficacy of antibody treatment in hospitalized COVID-19 patients

Patients admitted with COVID-19 at select hospitals may now volunteer to enroll in a clinical trial to test the safety and efficacy of a potential new treatment for the disease.

4 Aug 2020

FDA authorizes first two COVID-19 serology tests

Today, the U.S. Food and Drug Administration authorized the first two COVID-19 serology tests that display an estimated quantity of antibodies present in the individual's blood.

1 Aug 2020

FDA approves CBD oral solution for treatment of seizures related to tuberous sclerosis complex

Today, the U.S. Food and Drug Administration approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with tuberous sclerosis complex (TSC) in patients one year of age and older.

31 Jul 2020

NIH invests $248.7 million in new COVID-19 testing technologies to meet U.S. demand

The National Institutes of Health is investing $248.7 million in new technologies to address challenges associated with COVID-19 testing (which detects SARS-CoV-2 coronavirus).

31 Jul 2020

FDA announces manufacturers' voluntary commitment to phase-out certain PFAS used in food packaging

Today, the U.S. Food and Drug Administration is announcing that the manufacturers of certain per- and polyfluoroalkyl substances (PFAS) used for grease-proofing in paper and paperboard for food packaging (for example, as coatings on some fast-food wrappers, to-go boxes, and pizza boxes) have voluntarily agreed to phase-out their sales of these substances for use as food contact substances in the United States.

31 Jul 2020

Avoiding care during the pandemic could mean life or death

These days, Los Angeles acting teacher Deryn Warren balances her pain with her fear. She's a bladder cancer patient who broke her wrist in November. She still needs physical therapy for her wrist, and she's months late for a cancer follow-up.

31 Jul 2020

Novel vaccine candidate robustly protects non-human primates against SARS-CoV-2

The development of a safe and effective vaccine will likely be required to end the COVID-19 pandemic. A group of scientists, led by Beth Israel Deaconess Medical Center immunologist Dan H. Barouch, MD, PhD, now report that a leading candidate COVID-19 vaccine developed at BIDMC in collaboration with Johnson & Johnson raised neutralizing antibodies and robustly protected non-human primates against SARS-CoV-2, the virus that causes COVID-19.

30 Jul 2020

Scientists discover new set of channels that link deadliest malaria parasite and blood cells

Researchers at the National Institutes of Health and other institutions have discovered another set of pore-like holes, or channels, traversing the membrane-bound sac that encloses the deadliest malaria parasite as it infects red blood cells.

30 Jul 2020

New model can help local entities to prevent COVID-19 cases and hospitalizations

With communities throughout the United States combating surges in COVID-19 cases and hospitalizations, researchers at The University of Texas at Austin and Northwestern University have created a framework that helps policymakers determine which data to track and when to take action to protect their communities.

30 Jul 2020

FDA posts new template for over-the-counter COVID-19 diagnostic tests

Today, the U.S. Food and Drug Administration posted a new template for commercial developers to help them develop and submit emergency use authorization requests for COVID-19 diagnostic tests that can be performed entirely at home or in other settings besides a lab, such as offices or schools, and that could be available without a prescription.

29 Jul 2020

FDA issues warning letters to companies for illegally selling hangover remedies

Today, the U.S. Food and Drug Administration announced it has issued warning letters to seven companies for illegally selling unapproved products labeled as dietary supplements that claim to cure, treat, mitigate or prevent hangovers, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

29 Jul 2020

Health and Human Services News and Research

FDA approves first companion diagnostic that uses liquid biopsy and NGS technology

FDA approves first oral drug for treatment of spinal muscular atrophy

OU Health Sciences Center awarded five-year grant for suicide prevention

Carefully engineered spike protein can help develop COVID-19 vaccine

Hospital mobility programs can improve outcomes in older patients

NIH-Moderna investigational vaccine protects mice from infection with SARS-CoV-2

NIH harnesses artificial intelligence and medical imaging to fight COVID-19

Could labs that test livestock ease covid testing backlog for people? Well … maybe.

NIH trial to evaluate potential new therapeutics for mild, moderate COVID-19

Clinical trial to test safety, efficacy of antibody treatment in hospitalized COVID-19 patients

FDA authorizes first two COVID-19 serology tests

FDA approves CBD oral solution for treatment of seizures related to tuberous sclerosis complex

NIH invests $248.7 million in new COVID-19 testing technologies to meet U.S. demand

FDA announces manufacturers' voluntary commitment to phase-out certain PFAS used in food packaging

Avoiding care during the pandemic could mean life or death

Novel vaccine candidate robustly protects non-human primates against SARS-CoV-2

Scientists discover new set of channels that link deadliest malaria parasite and blood cells

New model can help local entities to prevent COVID-19 cases and hospitalizations

FDA posts new template for over-the-counter COVID-19 diagnostic tests

FDA issues warning letters to companies for illegally selling hangover remedies

Event guide: 6th Operationalize Expanded Access Programs Summit East eBook

Advancing Neuroscience Research Through Collaboration and Patient-Centered Innovation

The impact of vibration on microscopy

How Omics Technologies Are Transforming Biological Research and Drug Discovery

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