JD Supra1h
FDA Issues Draft Guidance on Accelerated Approval Focused on How the Agency Will Implement New Authorities
On December 5, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled Expedited Program for ...
BioSpace1h
When Are Confirmatory Trials ‘Underway’? FDA Releases New Accelerated Approval Guidance
Amid recent backlash stemming from market withdrawals and trial delays, the FDA seeks to further clarify its requirements for ...
BioSpace3h
FDA’s New AI Guidance Highlights Risks of Technology, Urges Early Sponsor Engagement
The FDA’s guidance on AI in drug development points to potentially life-threatening consequences of the technology, ...
Oculis Trial Shows Potential for Optical Neuroprotective Therapy
By Karen Roman Oculis Holding AG (Nasdaq: OCS) said Phase 2 of its neuroprotective candidate OCS-05 met key endpoints of ...
FiercePharma21h
FDA looks to clarify confirmatory trial mandate for accelerated approvals
In recent years, the FDA has amped up its supervision of accelerated approvals, including by requiring that confirmatory ...
STAT21h
FDA’s new guidance on AI in drug development centers the risk introduced by the technology
After nearly a decade of machine learning innovations, the FDA has issued its first draft guidance on the use of AI in drug ...
FDA issues first draft guidance on use of AI in drug, medical device development
Recognizing the increased use of artificial intelligence in the development of new therapies, the U.S. FDA on Monday released ...
dermatologyadvisor1d
FDA Alert: Dermatology Drug News Roundup
FDA experts report changes in drug approvals, warnings, and indications for products for use by dermatologists and aesthetic medicine professionals.
Targeted Oncology1d
Top 10 Lung Cancer Advances of 2024
Significant advancements in lung cancer treatment were seen throughout 2024, from new drug approvals to promising clinical ...
Fortress Biotech and Cyprium Therapeutics Announce U.S. FDA Acceptance and Priority Review of NDA for CUTX-101 for Treatment of Menkes Disease
Priority review granted for CUTX-101 with PDUFA target action date set for June 30, 2025Cyprium is eligible to receive royalties and up to $129 ...
Contract Pharma1d
Asieris & CDC Sign Investigational Drug Supply Agreement for APL-1202
Nitroxoline has not been approved by the FDA, and its use is therefore considered investigational. FLA patients will receive ...
Fortress, Cyprium announce FDA acceptance, priority review of NDA for CUTX-101
Fortress Biotech (FBIO) and its majority-owned subsidiary, Cyprium Therapeutics announced the acceptance for review of the New Drug Application ...