COVID-19
Shionogi Inc. has made significant progress in the development of an oral antiviral medication for COVID-19 prevention, submitting a New Drug Application (NDA) to the U.S. FDA for ensitrelvir fumarate. The FDA has accepted the NDA and set a target date for completion of the review (PDUFA date) as
COVID-19
As the Food and Drug Administration (FDA) restricts access to the COVID-19 vaccine for children due to conflicting guidance from Health Secretary Robert F. Kennedy Jr., pediatricians and health experts are expressing concerns about the potential for reduced vaccine availability and its impact on public health. The FDA's
COVID-19
Shionogi & Co., Ltd. has announced that the US FDA has accepted the New Drug Application (NDA) for ensitrelvir, an oral antiviral therapy for the prevention of COVID-19 following exposure to an infected individual. This marks a significant milestone in the development of ensitrelvir, which has shown promise in preventing
COVID-19
In a shift from previous guidelines, the Food and Drug Administration (FDA) has rescinded emergency use authorizations for Covid-19 vaccines for adults under 65, unless they have at least one underlying condition that puts them at higher risk for severe Covid. The new restrictions come as a new Covid variant,
COVID-19
Amid the ongoing debate over federal vaccine policy, CVS and Walgreens pharmacies are withholding Covid-19 vaccines in more than a dozen states. The decision is a result of the current regulatory environment and unclear messaging from the Food and Drug Administration. The uncertainty at the pharmacies is linked to the
COVID-19
As COVID-19 activity rises nationwide, the federal Food and Drug Administration has restricted who is eligible to receive the vaccine, narrowing its approval to those over 65 and individuals with existing health problems. This new policy breaks with the previous US recommendation for annual COVID-19 vaccines for all Americans older
COVID-19
A recent study from the University of Southern Denmark aimed to investigate the sensitivity and specificity of rapid antigen SARS-CoV-2 tests in preapproval and postapproval studies. Researchers analyzed 61 rapid antigen tests, identifying postapproval studies for 13 of them. The analysis incorporated 13 preapproval studies and 26 postapproval studies, involving
COVID-19
California is experiencing a significant surge in Covid-19 cases, driven by a new subvariant of the Omicron virus, with hospital admissions nearly doubling since July. Public health officials warn that the situation is concerning, especially for vulnerable populations, as the approval of updated vaccines is being slowed down by the
Securities law
Faruqi & Faruqi, LLP is investigating potential claims against Replimune Group, Inc. ("Replimune" or the "Company") (NASDAQ: REPL) and reminds investors of the September 22, 2025 deadline to seek the role of lead plaintiff in a federal securities class action that has been filed against the
Securities law
BioXcel Therapeutics, Inc., a biopharmaceutical company, has received positive preliminary meeting comments from the U.S. Food and Drug Administration (FDA) regarding its planned pre-sNDA meeting scheduled for August 20, 2025. The company is evaluating the feedback and plans to provide an update next week. The meeting is aimed at
Securities law
Faruqi & Faruqi, LLP, a leading national securities law firm, is investigating potential claims against Replimune Group, Inc. ("Replimune" or the "Company") (NASDAQ: REPL) following a federal securities class action filed against the Company. The lawsuit alleges that Replimune and its executives violated federal securities laws
Diseases
The development of biosimilars offers a cost-effective solution for treating immune-related diseases, but regulatory inconsistencies across different countries and agencies hinder their adoption. According to researchers at Wake Forest University School of Medicine, the current regulatory framework for biologics and biosimilars is complex and varies across the US, Europe, and
