Biodexa Pharmaceuticals announces outcome of a Type C meeting with FDA on eRapa
Biodexa Pharmaceuticals (BDRX) announced the results of its Type C meeting with the U.S. Food and Drug Administration, FDA, regarding the ...
After canceling meeting of independent advisers, FDA issues 2025-26 flu vaccine recommendations
The US Food and Drug Administration on Thursday issued recommendations for the composition of influenza shots for the ...
Biodexa Announces Successful Outcome of a Type C Meeting with FDA Regarding the Phase 3 Program for eRapa in FAP
Biodexa Announces Successful Outcome of a Type C Meeting with FDA Regarding the Phase 3 Program for eRapa in FAPClears the way to ...
BioSpace9h
FDA Makes Flu Vaccine Recommendations Without Convening Advisors
The recommendations were made in a closed session with representatives from CBER, the CDC and Department of Defense.
Healio8d
FDA approves Encelto for macular telangiectasia type 2
Encelto is the first FDA-approved treatment for macular telangiectasia type 2. The cell therapy slows the loss of macular photoreceptors through continuous delivery of ciliary neurotrophic factor.
STAT13h
A ‘conflict of interest-free’ FDA advisory committee policy is a terrible idea
But beware. Health and Human Services Secretary Robert F. Kennedy, Jr. has called for “conflict-free” advisory committee ...
FierceBiotech17d
Tandem Diabetes Care insulin-dosing algorithm nets FDA clearance for Type 2 diabetes
Tandem Diabetes Care has secured a new FDA clearance for its insulin dose-calculating algorithm, opening up its use to adults with Type 2 diabetes ... for Diabetes meeting scheduled for next ...
The Washington Post21d
FDA says Ozempic shortage is over, chilling boom in off-brand versions
Novo Nordisk’s Ozempic and Lilly’s Mounjaro treat Type 2 diabetes ... of the only real, FDA-approved semaglutide medicines is resolved, affirming that Novo Nordisk is meeting or exceeding ...
Yahoo Finance8d
Clearside Biomedical Announces Successful End-of-Phase 2 Meeting with the FDA and Alignment on Phase 3 Plans for Suprachoroidal CLS-AX in Wet AMD
ALPHARETTA, Ga., March 06, 2025 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD) (“Clearside” or the “Company”), a biopharmaceutical company ...
The American Journal of Managed Care7d
FDA Approves Revakinagene Taroretcel for Macular Telangiectasia Type 2
Revakinagene taroretcel-lwey (Encelto; Neurotech), an allogeneic encapsulated cell-based gene therapy, is the first therapy to be approved for macular telangiectasia type 2. The FDA approved ...
Monthly Prescribing Reference8d
FDA Approves Encelto for Macular Telangiectasia Type 2
Encelto, the first FDA-approved treatment for MacTel, is implanted intravitreally during a surgery performed by a qualified ophthalmologist. The Food and Drug Administration (FDA) has approved ...