dosing – Talk Bio

FDA Grants Regeneron Two Eylea HD Approvals in One Day

3 weeks ago talkbio0Tagged aflibercept, Approved, dosing, Eylea, Hodgkin Disease, Macular retinal edema, monthly, Ophthalmology specialty, Regeneron, Retinal Vein Occlusion, RVO, United States Food and Drug Administration

Regeneron; FDA approval; Eylea HD; macular edema; retinal vein occlusion; monthly dosing; aflibercept; ophthalmology; RVO

FDA Approves New Indication and Monthly Dosing for Regeneron’s Eylea HD

3 weeks ago talkbio0Tagged aflibercept, Approved, dosing, Eylea, Hodgkin Disease, Macular retinal edema, monthly, Ophthalmology specialty, Pre-filled Syringe, Regeneron, Retinal Diseases, Retinal Vein Occlusion, United States Food and Drug Administration

FDA approval; Eylea HD; Regeneron; macular edema; retinal vein occlusion; monthly dosing; ophthalmology; aflibercept; retinal diseases; pre-filled syringe

Eisai Expands Leqembi Subcutaneous Label, Accelerates Early U.S. Launch Progress for Alzheimer’s Disease

1 month ago talkbio0Tagged Alzheimer 's disease, at-home injection, dosing, Eisai, expansion, Labels (device), Leqembi, Maintenance, sBLA, starting dose, status - In progress, Subcutaneous Autoinjector, supplemental biologics, United States Food and Drug Administration

Eisai; Leqembi; subcutaneous autoinjector; label expansion; Supplemental Biologics License Application (sBLA); FDA; maintenance dosing; starting dose; early Alzheimer’s disease; at-home injection; launch progress

Closed Loop Medicine Secures Additional Key GLP-1 Patent for Its AI-Based Dosing Platform: Powering Personalized, Direct-to-Patient Therapies

1 month ago talkbio0Tagged adaptive dosing, AI-based, Closed Loop Medicine, dosing, Glucagon-Like Peptide 1, incretin drugs, Legal patent, personalized therapies, semaglutide, WeDosify

Closed Loop Medicine; GLP-1; patent; AI-based dosing; personalized therapies; semaglutide; incretin drugs; WeDosify; adaptive dosing; direct-to-patient

Pfizer Acquires Metsera to Compete with Zepbound in Obesity Market

3 months ago talkbio0Tagged Acquisition, Amylin, Clinical Trials, dosing, Glucagon-Like Peptide 1, MET-097i, MET-233i, Metsera, mimetics, monthly, Obesity, Pfizer, Zepbound

Pfizer; Metsera; obesity treatment; Zepbound; GLP-1 therapies; MET-233i; monthly dosing; amylin mimetic; MET-097i; acquisition; clinical trials

Eisai Secures FDA Approval for Leqembi Autoinjector for Maintenance Dosing in Alzheimer’s Patients

3 months ago talkbio0Tagged Alzheimer 's disease, Approved, at-home, AutoInjector, Biogen, dosing, Eisai, Lecanemab, Leqembi, Maintenance, Subcutaneous Injections, United States Food and Drug Administration

Eisai; Leqembi; lecanemab; FDA approval; autoinjector; subcutaneous injection; maintenance dosing; Alzheimer’s disease; at-home treatment; Biogen

Regeneron Faces Another FDA CRL for Eylea HD, Predicts August PDUFA Delay

4 months ago talkbio0Tagged Application procedure, dosing, Eylea HD, IL31RA gene, Interval, PDUFA, Regeneron, Retinal Diseases, Supplement, United States Food and Drug Administration

Regeneron; Eylea HD; CRL; FDA; PDUFA; supplemental Biologics License Application; dosing intervals; retinal diseases

FDA Approves Updated Dosing for Lilly’s Kisunla to Lower Brain Swelling Risk

5 months ago talkbio0Tagged Alzheimer 's disease, Cerebral Edema, dosing, eli lilly, Kisunla, label update, Neuregulins, Safety, Treatment Protocols, United States Food and Drug Administration

FDA; Kisunla; Eli Lilly; Alzheimer’s disease; dosing regimen; brain swelling; ARIA; safety; label update; TRAILBLAZER-ALZ 6

FDA Approves CSL’s Andembry, Directly Competing With Takeda’s Takhzyro in HAE

6 months ago talkbio0Tagged Andembry, Angioedemas, Hereditary, Approved, dosing, factor XIIa, garadacimab-gxii, Inhibitor, SMPX gene, Subcutaneous Injections, Takeda, Takhzyro, United States Food and Drug Administration

Andembry; garadacimab-gxii; FDA approval; hereditary angioedema; HAE; CSL; Takhzyro; Takeda; factor XIIa inhibitor; once-monthly dosing; subcutaneous injection

Leqembi’s Expansion and Blood Test Impact: Analyst Sees Gradual Uptake Boost

7 months ago talkbio0Tagged Adoption, Alzheimer 's disease, Approved, AutoInjector, Biogen, dosing, Eisai, Hematologic Tests, launch, Leqembi, Maintenance, Market, subcutaneous, United States Food and Drug Administration

Leqembi; Eisai; Biogen; Alzheimer’s disease; FDA approval; blood test; launch; maintenance dosing; autoinjector; subcutaneous; market adoption