Securities law
Sarepta Therapeutics, Inc., a biopharmaceutical company, has announced a clinical hold on its investigational gene therapy clinical trials for limb girdle muscular dystrophy (LGMD) by the U.S. Food and Drug Administration (FDA). The hold includes four product candidates: SRP-9003, SRP-9004, SRP-6004, and SRP-9005. This decision follows the company'
Securities law
BioXcel Therapeutics, Inc. has announced the submission of a pre-supplemental New Drug Application (pre-sNDA) meeting package to the U.S. Food and Drug Administration (FDA) for IGALMI(r) in support of a potential label expansion for outpatient use for the acute treatment of agitation associated with bipolar disorders or schizophrenia.
Restaurants
The Maharashtra Food and Drug Administration (FDA) has temporarily suspended the licence of Goodluck Cafe in Pune after a glass shard was found in its signature dish, the bun maska. The incident came to light after a couple claimed to have discovered the shard in the food item they had
Restaurants
Cafe Goodluck, one of the oldest and most popular eateries in Pune, has been temporarily closed after the Food and Drug Administration (FDA) suspended its food licence over alleged violations of the Food Safety Act. The incident was triggered by a viral video showing glass shards in the cafe'
Food supply
The Environmental Working Group has applauded the reintroduction of a House bill that requires the Food and Drug Administration to review the safety of food chemicals. The Food Chemical Reassessment Act of 2025, introduced by Rep. Jan Schakowsky (D-Ill.), aims to ensure the safety of chemicals that have entered the
Food supply
The Food and Drug Administration (FDA) has made significant strides in its first 100 days under new leadership, marking a notable shift towards a more transparent, science-driven approach. With a focus on addressing long-standing issues and championing consumer protection, the agency has initiated dozens of key initiatives across its purview.
COVID-19
The U.S. Food and Drug Administration has ordered Pfizer and Moderna to expand their warning labels on COVID-19 vaccines due to a rare risk of heart inflammation in teen boys and young men. The updated warnings highlight data from FDA safety monitoring and a 2023 study, which indicates a
COVID-19
As the United States transitioned from a pandemic to endemic phase, the Food and Drug Administration (FDA) has announced a new framework for COVID-19 vaccine distribution. The agency has stated that it will only approve new versions of the vaccine for adults 65 years of age and older, as well
COVID-19
The US Food and Drug Administration's (FDA) Vaccine and Related Biological Products Advisory Committee voted unanimously to recommend targeting the JN.1 family of viruses for the 2025-26 Covid-19 vaccines, giving the agency latitude to keep the current shots or update its formulas to more closely match circulating
Cable News Network
Tens of thousands of patients in the United States who have come to rely on compounded GLP-1 medications for weight loss and diabetes treatment are facing uncertainty as a federal deadline approaches to halt the sale and production of off-brand products. The shortage, which began in 2022 due to increased
COVID-19
The Food and Drug Administration (FDA) has announced a significant shift in its approach to Covid-19 boosters, limiting access to healthy Americans under 65 without clear evidence of clinical benefit. In a commentary piece published in the New England Journal of Medicine, FDA Commissioner Marty Makary and Vinay Prasad, director
COVID-19
The Food and Drug Administration (FDA) is redefining its approach to COVID-19 vaccine approval, shifting its focus towards prioritizing high-risk groups, including older adults and those with certain health conditions. This change marks a significant shift in the agency's strategy, narrowing the scope of vaccine eligibility to those
