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 ...
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Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial ...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 ...
policymed.com15d
FDA Releases Draft Guidance on the Accelerated Approval Process
The United States Food and Drug Administration (FDA) recently released a draft guidance, Expedited Program for Serious ...
Drug compounders sue US FDA over removal of Wegovy, Ozempic from shortage list
Drug compounders sued the U.S. Food and Drug Administration on Monday over its decision last week to remove Novo Nordisk's ...
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 ...
JD Supra3d
FDA Final Rule for “Healthy” Nutrient Content Claims Effective Date Looms but Rule’s Future Is Uncertain
After years of rulemaking with impassioned input from food producers, industry stakeholders, and consumer groups, on December ...
FDA meeting to choose flu vaccine composition canceled without explanation
A March meeting of outside advisers to the United States Food and Drug Administration to discuss the composition of flu ...