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Today’s FDAapproval of Cabenuva represents a shift in the way HIV is treated, offering people living with HIV a completely new approach to care,” said Lynn Baxter, Head of North America, ViiV Healthcare. Cabenuva reduces the treatment dosing days from 365 days to 12 days per year. Janssen is a Johnson & Johnson company.
Gene therapy could potentially treat a range of severe genetic brain disorders, which currently have no cures and few treatment options. Sonia Vallabh and Eric Minikel , two researchers at the Broad who are developing treatments for prion disease, are excited by the potential of the AAVs to deliver brain therapies in humans.
FDAApproves Veklury (remdesivir) for the Treatment of COVID-19. Food and Drug Administration (FDA) has approved the antiviral drug Veklury (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization. The speed and rigor with which Veklury has been developed and approved in the U.S.
Several FDA-approved drugs – including for type 2 diabetes, hepatitis C and HIV – significantly reduce the ability of the Delta variant of SARS-CoV-2 to replicate in human cells, according to new research led by scientists at Penn State. ” The findings published today (Feb. ” The findings published today (Feb.
Valentine — On November 22, 2022, FDAapproved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.
Food and Drug Administration (FDA) has approved TICOVAC (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older. 1 TICOVAC is the only FDA-approved vaccine to help protect U.S. Following today’s FDAapproval, the U.S. in 1-15 year olds and 98.7-100%
Approval is for Cytomegalovirus, a Type of Herpes Virus. Livtencity works by preventing the activity of human cytomegalovirus enzyme pUL97, thus blocking virus replication. director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research. Today, the U.S.
Although the novel coronavirus is the subject of nearly every media story right now, several years ago it was the Zika virus (ZIKV) gathering a great deal of attention. There are currently no targeted therapeutics for its treatment, nor is there an existing vaccine.
The newest FDA-approved gene therapy treats the severe, skin-peeling condition dystrophic epidermolysis bullosa (DEB). The gene treatment has been a long time coming, but it differs from the handful of other approved gene therapies: it isn’t a one-and-done.
Gilead Sciences has asked the FDA to approve its drug remdesivir to treat COVID-19 patients. The treatment is already available on an emergency basis for people suffering with severe symptoms from coronavirus. It has not received general approval to treat the virus in the US, but has in several European countries and Japan.
By Allessandra DiCorato February 8, 2024 Credit: NIAID Integrated Research Facility (IRF) in Fort Detrick, Maryland Scanning electron image of the Lassa virus budding off a cell. Other scientists had discovered that this gene was critical for the Lassa virus to enter cells. Finding participants for the study would be challenging too.
After the outbreak ended, it took another three years for the first Ebola vaccine by Merck to be approved. When COVID-19 emerged in 2019, by contrast, mRNA vaccines developed by Pfizer and Moderna took just 326 days from the initial sequencing of the virus to gaining approval for emergency use.
Food and Drug Administration (“FDA”) has approved the Investigation New Drug (IND) application for TG-1000, a novel treatment for influenza A and B. The first US patent for TG-1000 was successfully prosecuted and granted by the United States Patent and Trademark Office on Jan 14 th , 2020.
Pfizer’s PAXLOVID™ receives FDAapproval for adult patients at high risk of progression to severe COVID-19 Pfizer Inc. million treatment courses of PAXLOVID have been prescribed in the U.S. 1) “Great advancements have been made in the fight against COVID-19, yet the virus remains a present and unpredictable concern.
Food and Drug Administration (FDA) approval for the cobas® HIV-1/HIV-2 Qualitative Test for use on the fully automated cobas® 6800/8800 Systems in the U.S. Among them, more than 160,000 people did not know their HIV status, and only 53 percent were virally suppressed having low amounts of virus circulating in their blood.
Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for baricitinib for the treatment of adults with moderate to severe atopic dermatitis (AD). OLUMIANT is a once-daily, oral JAK inhibitor approved in the U.S.
AnQlar is a nanoparticle intended to help prevent the spread of negatively charged viruses such as COVID-19 and influenza via intranasal spray, and has been shown to inhibit the ability of the virus to replicate at non-toxic concentrations. We look forward to further collaboration with Virpax in the near-future.”
Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for upadacitinib in the treatment of adults and adolescents with moderate to severe atopic dermatitis. The approved dose for RINVOQ in rheumatoid arthritis is 15 mg. vice chairman and president, AbbVie.
Food and Drug Administration issued an emergency use authorization (EUA) for a new monoclonal antibody for the treatment of COVID-19 that retains activity against the omicron variant. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. director of the FDA’s Center for Drug Evaluation and Research.
60,000 people across Britain may have been suffering from prolonged symptoms of coronavirus months after contracting the virus. Genetech scores sixth FDAapproval in lung cancer with Gavreto. FDAapproves GlaxoSmithKline’s Trelegy for treating asthma. FDAapproves GlaxoSmithKline’s Trelegy for treating asthma.
In a clinical trial of patients with COVID-19, casirivimab and imdevimab, administered together, were shown to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo. SILVER SPRING, Md. , Hahn , M.D.
The messenger RNA (mRNA) vaccines encode a form of the spike (S) protein of SARS-CoV-2 virus. The vaccine teaches the cells to make a piece of the spike protein, which triggers an immune response to help prevent illness if later exposed to the virus.
FDAApproves First-In-Class Topical Klisyri to Treat Actinic Keratosis .
Food and Drug Administration as part of its review of our Emergency Use Authorization submission, and we continue to focus on completing our ongoing trials evaluating REGN-COV2 for the treatment and prevention of COVID-19.” Serious adverse events were numerically more frequent with placebo than REGN-COV2 treatment (0.8%
For laboratory workers: TBE vaccination is recommended for those with a potential exposure to the TBE virus (TBEV). Food and Drug Administration (FDA) approved TicoVac™ for active immunization to prevent TBE in individuals 1 year of age and older. 1 TicoVac™ is the only FDA-approved vaccine to help protect U.S.
While the preliminary nature of Phase 2 results from COVID-19 neutralizing monoclonal antibodies may have limited acceptance of treatment, these Phase 3 data further strengthen the available evidence,” said Daniel Skovronsky, M.D., It remains under review by the FDA. have reached record highs. . have reached record highs.
The end-of-year FDAapproval of the first CRISPR-based therapy , for sickle cell disease, came a mere dozen years after Jennifer Doudna and Emmanuelle Charpentier introduced the technology. Sickle Cell Disease The CRISPR-based treatment for sickle cell disease is Casgevy , from CRISPR Therapeutics and Vertex Pharmaceuticals.
Now, new research led by investigators at Harvard Medical School and Boston Children’s Hospital points to a well-known and widely available drug called disulfiram as a possible treatment for COVID-19. If disulfiram’s effect against SARS-CoV-2 is confirmed, it could become a useful tool against the virus. A Pandemic Pivot.
Hepatitis C virus (HCV) infection is a global health problem with complications that place a significant economic burden on national health systems. Despite advances in clinical research, there remain significant challenges as only 20% of HCV cases are diagnosed, and of these, only 15% receive treatment.
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) has granted Orphan Drug Designation (ODD) to Annamycin for treatment of soft tissue sarcomas. .
The applications of mRNA-based therapies in cancer research represent one of the next groundbreaking steps toward improved cancer treatments. Adoptive T Cell therapies, therapeutic antibodies, and immunomodulatory proteins represent just some of the potentially beneficial treatment strategies for successful mRNA cancer trials.
“Our vision is to discover and deliver life-transforming treatments guided by our commitment to patients, our people and the planet,” said Christophe Weber, Takeda president and chief executive officer. To date, it has received both Breakthrough Therapy designation and Orphan Drug designation from the FDA.
It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. AZD1222 (SARS-CoV-2 vaccine) FDAApproval History. Source: AstraZeneca . Source link.
It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. AZD1222 (SARS-CoV-2 vaccine) FDAApproval History. Source: AstraZeneca. Source link.
Food and Drug Administration (FDA). The casirivimab and imdevimab antibody cocktail is designed to mimic what a well-functioning immune system does by using very potent antibodies to neutralize the virus,” said George D. Please see the Fact Sheet and FDA Letter of Authorization at [link]. Yancopoulos, M.D.,
We hope this effective, well-tolerated and simple-to-administer vaccine will now begin to have a real impact on this deadly virus. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body. AZD1222 (SARS-CoV-2 vaccine) FDAApproval History.
Trial participants to date are aged 18 years or over, who are healthy or have medically stable chronic diseases and are at increased risk for being exposed to the SARS-CoV-2 virus. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.
Food and Drug Administration (FDA) for the treatment of AA. There are currently no FDA-approvedtreatments for AA. “This level of high-quality research is needed to advance our understanding and the treatment of this frequently devastating disease.”
Patients, caregivers and healthcare providers can find sites with COVID-19 antibody treatments through these links to the HHS or National Infusion Center Association locator tools. . “Additionally, as expected, the virus continues to mutate, with the possibility of developing resistance to any one antibody. Yancopoulos , M.D.,
That company’s breast cancer treatment Trodelvy, which was granted accelerated approval from the U.S. billion acquisition of Germany-based Myr GmbH, a company focused on developing therapies for treatment of chronic hepatitis delta virus (HDV), the most severe form of viral hepatitis. Most Read Today. Source link.
It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. AZD1222 (SARS-CoV-2 vaccine) FDAApproval History. Source: AstraZeneca. Source link.
Yet the quest to save more lives from COVID-19 isn’t even close to being finished, and researchers continue to work intensively to develop new and better treatments. Another arm of this trial has just started, testing inhaled, easy-to-administer interferon beta-1a treatment in adults with mild-to-moderate COVID-19 who are not hospitalized.
These follow-on data provided the first definitive prospective evidence demonstrating anti-viral activity for a treatment regimen now available for COVID-19, and also further documented the ability of this treatment to decrease the need for further medical attention,” said George D. Yancopoulos , M.D.,
NASDAQ: REGN) received today a recommendation from the independent data monitoring committee (IDMC) for the REGN-COV2 antibody cocktail treatment trials for COVID-19 that the current hospitalized patient trial be modified. TARRYTOWN, N.Y. , Regeneron Pharmaceuticals, Inc.
To evaluate the immunogenicity of the Sanofi-GSK vaccine as a booster, human immune sera samples were tested by Monogram Biosciences San Francisco, CA using an FDA-approved standardized pseudovirus neutralization test (pVNT) against the D614G prototype virus. for efficacy, immunogenicity and safety compared to a placebo.
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