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In 2023, the FDA approved six vaccines, including 2 for respiratory syncytial virus (RSV), and the first vaccine to prevent the mosquito-borne virus chikungunya.
Innovation in the vaccine area continues. In 2023, the FDA approved six vaccines, including several important firsts. But they face a difficult landscape where federal policies dictate coverage.
CDC to weigh who should get updated COVID-19 vaccines after FDA approval, Novavax says its updated COVID-19 vaccine is ready for distribution, and Walgreens partners with Pearl Health to expand primary care services.
The federal agencies said that they will continue to work closely with manufacturers to maintain the availability of the vaccines through the end of 2023 and early 2024 to meet the demand during the RSV season.
The FDA approved a licensure request for Fluzone High-Dose Quadrivalent, Flublok Quadrivalent, and Fluzone Quadrivalent for use in the upcoming 2022-2023 flu season, providing influenza vaccination for adults 65 years of age and older.
This year, there are new vaccines to help at-risk populations ward off severe sickness, including that caused by RSV. Here’s what you need to know about the new FDA-approved RSV vaccine. Is there a vaccine for RSV? Not all vaccines work via the same science. Is there an RSV vaccine for children? What is RSV?
AC Immune SA has received Fast Track designation from the US Food and Drug Administration (FDA) for its anti-amyloid beta (Abeta) active immunotherapy vaccine candidate for Alzheimer’s disease. The anti-Abeta therapy “specifically targets the most toxic forms of Abeta” according to Dr Andrea Pfeifer, CEO of AC Immune SA.
The US Food and Drug Administration (FDA)-approved treatment, is the first RSV vaccine indicated for infants from birth to six months of age. US FDA granted approval of Abrysvo to Pfizer Inc. This news follows similar regulatory action by the US FDA in recent months. percent within 90 days after birth.
PENBRAYA (meningococcal groups A, B, C, W and Y vaccine), the first and only pentavalent vaccine that provides the broadest serogroup coverage of any meningococcal vaccine available in the US for meningococcal disease in individuals aged 10 to 25 years old, has been approved by the US Food and Drug Administration (FDA).
The R21/Matrix-M malaria vaccine, developed by the University of Oxford , has been approved for use in Ghana (13 April 2023) and was authorised for use in Nigeria on 17 April. Granted full national licensure by the country’s Food and Drugs Authority (FDA Ghana), it is authorised for children aged 5 to 36 months.
Sanofi has added to its vaccine pipeline with an agreement to acquire Austria’s Origimm Biotechnology and its vaccine-based immunotherapy for people with acne. It will highlight vaccines for pneumococcal disease, meningitis, respiratory syncytial virus (RSV), influenza, and chlamydia. Photo by Scott Webb on Unsplash.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended authorising an adapted COVID-19 Comirnaty vaccine targeting the Omicron XBB.1.5 Additionally, the updated COVID-19 vaccine is recommended for children from six months to four years old. subvariant. Omicron XBB.1.5
” Post-construction, the facility “will harness mRNA science that aims to develop and deliver innovative vaccines to the UK public that address emerging threats from respiratory viruses.” Construction will begin in 2023. The MITC will also include a clinical biomarker laboratory.
For 20 of the leading biopharmaceutical companies, the second quarter (Q2) of 2023 has brought an aggregate market capitalisation growth of 2.3 trillion in the Q1 of 2023 to $3.56 trillion in Q2 2023. Q2 2023 biopharma market capitalisation results Eli Lilly “Eli Lilly witnessed the largest market capitalisation growth of 36.1
Recently there have been several key advances in the clinical development of messenger RNA (mRNA) vaccines, including vaccines for RSV and a personalised cancer vaccine. Progress on mRNA vaccines for RSV Moderna’s mRNA vaccine mRNA-1345 demonstrated vaccine efficacy of 83.7
Clinical trial results presented at the US IDWeek conference, revealed a three-dose series of the HEPLISAV-B vaccine prevents hepatitis B virus (HBV) in HIV patients not previously vaccinated against or infected with the virus. At week 28, the study assessed the vaccine’s safety and levels of anti-HBV surface antibodies (HBsAbs).
The present article focuses on opportunity, the unmet need which lies at the heart of better healthcare provision, and two areas of growth and opportunity: Point of Care Diagnostics, and the new pharmacotherapy classes which will commercialise for the first time in 2023. Innovation will power the market.
Pfizer has announced that the FDA has accepted its application for a respiratory syncytial virus (RSV) vaccine for older adults, with the FDA expected to come to a decision by Spring 2023. read more.
The success of the Covid-19 messenger ribonucleic acid (mRNA) vaccines highlighted the major advantages of utilising mRNA technology in vaccine development.
The FDA has started its review of Pfizer’s respiratory syncytial virus (RSV) vaccine for older adults, fast-tracking the biologics license application (BLA) with a decision due in May 2023. Pfizer is also developing a version of the vaccine aimed at expectant mothers, designed to protect against RSV illness in newborns.
The US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has accepted the Biologics License Application (BLA) for nirsevimab for the prevention of respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI) in all infants. The FDA has indicated they will work to expedite their review.
Peter Marks, MD, PhD Director, Center for Biologics Evaluation and Research CBER/FDA Peter Marks, MD, PhD, Director, Center for Biologics Evaluation and Research, US FDA, presented on “The Importance of Manufacturing in Cell and Gene Therapy Development” in an afternoon keynote on 1 February.
Food and Drug Administration (FDA) announced its approval of the Boostrix vaccine, commonly known as Tdap (combination of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis) for immunization administration during the third trimester of pregnancy to prevent pertussis in infants younger than two months of age.
Food and Drug Administration put a clinical hold on a Novavax application for a combination Covid-19 and influenza vaccine and stand-alone flu inoculation , The Wall Street Journal writes. who received the vaccine in January 2023.
The US Department of Health and Human Services (HHS) and the Department of Defense have modified their existing agreement with Novavax to secure additional doses of the Covid-19 vaccine, Adjuvanted (NVX-CoV2373). million additional doses of its Covid-19 vaccine. Under the modified deal, Novavax will deliver up to 1.5
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