FierceBiotech4d
FDA scraps adcomm for Applied's rare disease drug ahead of November decision
After pushing back the decision date for Applied Therapeutics’ metabolic disorder drug govorestat, the FDA has now decided ...
GlobalData on MSN9d
FDA approves Roche’s Tecentriq Hybreza for cancer
The US Food and Drug Administration (FDA) has approved Roche's Tecentriq Hybreza, a subcutaneous anti-PD-(L)1 cancer ...
FierceBiotech9d
FDA pushed to be more open, collaborative to accelerate rare disease R&D
The FDA should be more open and collaborative to unleash a surge in approvals of rare disease drugs, according to a report by ...
Neuralink Brain Implant Wins an FDA Nod to Tackle Blindness
The regulatory approval is just the first phase of a long project, but Neuralink owner Elon Musk is already touting his brain ...
FiercePharma10d
Intercept's Ocaliva approval in jeopardy after FDA flags concerns in advisory committee briefing doc
For Intercept Pharmaceuticals’ beleaguered liver disease drug Ocaliva, the hits just keep coming. | Ahead of an advisory ...
centerforbiosimilars13d
BioRationality: FDA Clarification Provides New Indications and Process Change for Biosimilars
Sarfaraz K. Niazi, PhD, explains the FDA's new guidelines on post-approval changes for biosimilars, emphasizing the processes ...
Acsh.org12d
Making America Healthy Again: Conflicted Interests
Calley Means, co-founder of TruMed, recently raised concerns about conflicts of interest within the FDA and the influence of ...
Medscape11d
AI's Drug Revolution, Part 2: New Uses for Old Drugs
Hoping to skirt the slow pace of new drug development, researchers are leaning on AI to uncover fresh uses for known ...
Analytics Insight4d
Neural Ink's Blindsight Implant Gets FDA Green Light
Elon Musk's brain-chip startup has just received its first big win, the breakthrough device, experimental implant, Blindsight ...
Public Radio Tulsa1d
No needles required: The FDA approves an at-home flu vaccine
The nasal spray option could encourage more people who have fears of doctors or needles to inoculate themselves against the ...
Ozempic: GLP-1 Drugs May Help Prevent 34,000 Heart Attacks and Strokes Per Year
GLP-1 drugs like Ozempic and Wegovy may help reduce the risk of cardiovascular disease and prevent more than 34,000 heart ...
National Academies of Sciences%2c Engineering%2c and Medicine10d
To Increase Pace and Volume of Drug Approvals for Rare Diseases, Report Recommends FDA Enhance Information Sharing, Improve Collaboration
and then scale up and expand successful programs and modify or sunset those that are not improving the regulatory process. Much of the data to support licensure applications for new drugs submitted ...