August 22, 2023
Via: PMLiVEThe FDA’s decision allows Abrysvo to be given to those who are 32 to 36 weeks into their pregnancy to prevent lower respiratory tract disease (LRTD) and severe LRTD in infants from birth until they are six months old. RSV […]
August 22, 2023
Via: Drugs.comWomen may soon have a vaccine they can take during a pregnancy to help protect their newborn from respiratory syncytial virus (RSV), following U.S. Food and Drug Administration approval of the shot, called Abrysvo, on Monday The vaccine is designed […]
August 14, 2023
Via: Biopharma DiveThe Food and Drug Administration has delayed by three months its decision on what could be the first vaccine available in the U.S. for chikungunya virus. In an announcement Monday, French vaccine maker Valneva said the FDA extended an evaluation […]
August 11, 2023
Via: PMLiVESchool-aged children will receive the flu vaccine either at school or at community clinics, and those who are aged two and three years or have long-term health condition will be offered the vaccine at GP surgeries. The rollout follows the […]
August 3, 2023
Via: Drugs.comWhile both the Moderna and Pfizer COVID-19 vaccines are considered safe and highly effective, new research finds the Moderna shot has been the safest and most effective for seniors. “The results of this study can help public health experts weigh […]
July 31, 2023
Via: PMLiVEThe modelling study, Global and regional burden of attributable and associated bacterial antimicrobial resistance avertable by vaccination, was carried out by the World Health Organization (WHO), the International Vaccine Institute, Korea (IVI) and the London School of Hygiene and Tropical […]
July 25, 2023
Via: Drugs.comMost early childhood vaccines require three or four doses for best protection, but more than 1 in 6 toddlers aren’t getting them all, leaving them vulnerable to potentially deadly infections, a new study finds. There are many reasons that kids […]
July 21, 2023
Via: Biopharma DiveAdults over the age of 60 now have two RSV vaccines to choose from in the U.S. and Europe. A new antibody treatment is available to prevent infants from infections, too. So far, Pfizer is the only drugmaker to reach […]
July 12, 2023
Via: Biopharm InternationalBiosynth announced on July 11, 2023 that it has acquired celares, a leader in the development and manufacture of conjugate vaccines and bioconjugate drugs, activated PEGs, and polymer-based drug delivery excipients, according to a company press release. The acquisition will […]
July 7, 2023
Via: Contract PharmaSanofi is partnering with Saudi drugmakers Arabio and Lifera to increase the production of vaccines in Saudi Arabia. Lifera and Sanofi signed a Memorandum of Understanding (MOU) enabling the two companies to strengthen local manufacturing. With the MOU Sanofi, LIfera […]
June 29, 2023
Via: Drugs.comAmericans ages 60 and up can get their vaccine for respiratory syncytial virus (RSV) this fall, the U.S. Centers for Disease Control and Prevention announced Thursday. On Thursday, Dr. Rochelle Walensky, the outgoing CDC director, gave her signature to a […]
June 19, 2023
Via: PMLiVEThe Vaccines and Related Biological Products advisory committee (VRBPAC) voted 21 to zero in favour of the monovalent XBB-lineage vaccines, and generally agreed that vaccines targeting the XBB.1.5 subvariant would be preferred. XBB.1.5, which is another descendant of the Omicron […]
June 15, 2023
Via: Drugs.comAn advisory panel to the U.S. Food and Drug Administration voted unanimously on Thursday to recommend that COVID booster shots be updated for the fall to protect solely against one of the three XBB variants that have taken hold in […]
June 14, 2023
Via: Drugs.comCOVID-19 boosters may be offered this fall, but first scientists need to determine what strains to target and who should receive the shots. Advisers to the U.S. Food and Drug Administration are slated to meet Thursday to discuss plans for […]
June 9, 2023
Via: Drugs.comA U.S. Food and Drug Administration advisory panel on Thursday recommended that the agency approve an RSV vaccine for infants and some toddlers. The monoclonal antibody shot would protect against respiratory syncytial virus (RSV) in infants born during or entering […]
June 8, 2023
Via: Biopharma DiveThe development of therapeutic vaccines for cancer has met repeated disappointment over the years, as treatments aimed at cancers of the brain, lung and kidney have failed in clinical testing. But now, developers like Moderna, BioNTech and Gritstone Bio are […]
FDA, Industry, Regulations, Vaccines
June 1, 2023
Via: Drugs.comOlder adults may have a second vaccine option for RSV following the U.S. Food and Drug Administration’s approval of a Pfizer vaccine on Wednesday. The other shot for adults 60 and up is made by GSK. It was approved May […]
May 30, 2023
Via: Drugs.comThe U.S. Food and Drug Administration has approved Brixadi (buprenorphine) extended-release injection to treat moderate-to-severe opioid use disorder. Brixadi is approved for both weekly (8 mg, 16 mg, 24 mg, 32 mg) and monthly (64 mg, 96 mg, 128 mg) […]
May 26, 2023
Via: PMLiVEPfizer’s oral antiviral, which has now been granted full approval to treat mild-to-moderate COVID-19 in adults at a high risk for progression to severe disease, has been available in the US since December 2021 under the FDA’s accelerated approval pathway. […]
May 25, 2023
Via: Drugs.comAmericans with COVID-19 have been taking Paxlovid since it was approved under emergency use in late 2021. Today, the U.S. Food and Drug Administration granted full approval to the drug. This approval will allow drugmaker Pfizer to sell the medication […]