Central drug regulator creating guidelines for gene therapies, biosimilars: DCGI
Cell and gene therapies, which involve the transfer of genetic material or cells into a patient for treatment, have been on ...
Fierce Healthcare6d
FDA declares semaglutide shortage over, spelling end to compounded GLP-1 market, for now
The Food and Drug Administration on Friday announced that semaglutide, the active ingredient in weight loss drugs Ozempic and ...
Viatris Falls to 52-Week Low; FDA Import Alert for India Facility Weighs on Guidance
Viatris shares fell to a 52-week low after the drug company said issues related to a India facility are expected to hurt 2025 total revenue by about $500 million. The stock was recently down 14% to $9 ...
FDA cancels March meeting on flu vaccine composition without explanation
The FDA's decision to cancel the March meeting raises questions about flu vaccine guidance for manufacturers this year ...
JD Supra3d
FDA Reveals AI Development Cheat Sheet in Highly Anticipated Draft Guidances
Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial ...
ClearPoint Neuro: Drug Delivery Prospects Continue To Strengthen
ClearPoint's Q4 updates: neurosurgery growth, expanding services, controlled cash burn and high-potential partner programs ...
manilatimes9h
MAPS Releases Template to Assist in Federal Drug Sentencing Reform Efforts
In January, the U.S. Sentencing Commission announced proposed amendments to federal drug sentencing guidelines, including ...
JD Supra3d
FDA Continues Push to Improve Food Labeling Practices in the United States
In September 2022, former President Biden convened the White House Conference on Hunger, Nutrition, and Health, during which ...
Generic Wegovy, Ozempic compounds may become harder to get as FDA removes drug from shortage list
Compounding pharmacies producing cheaper semaglutide products have been given notice they will soon have to stop, as the drug ...
Hims stock tumbles 20% following Q4 report, 2025 guidance
Hims & Hers (HIMS) stock tumbled 20% post-market after the company released its Q4 earnings report and 2025 guidance amid a ...
India's drug regulator to streamline export process to reduce workload
India's drug regulator aims to implement various reforms, including streamlining export clearances for unapproved drugs and ...
Researchers helping to develop the first US guidelines for ADHD in adults
Thirty years ago, medical and psychological experts believed attention deficit hyperactivity disorder (ADHD) was a childhood ...