Approved – Talk Bio

FDA Approves GSK’s Gepotidacin (Blujepa) for Uncomplicated Urogenital Gonorrhea

4 hours ago talkbio0Tagged Antibiotics, Approved, Blujepa, gepotidacin, Gonorrhea, SmithKline Beecham, United States Food and Drug Administration

GSK; gepotidacin; Blujepa; FDA approval; gonorrhea; antibiotic

Dyne Therapeutics Reports Positive Results for Duchenne Drug DYNE-251, Plans FDA Approval Submission

3 days ago talkbio0Tagged Accelerated, Approved, Biological Factors, Breakthrough Therapy Designation, Clinical Trials, DELIVER (veterinary product), Dyne Therapeutics, DYNE-251, License Application, Muscular Dystrophy, Duchenne, United States Food and Drug Administration

Dyne Therapeutics; DYNE-251; Duchenne muscular dystrophy; exon 51 skipping; DELIVER trial; FDA Breakthrough Therapy Designation; Biologics License Application; accelerated approval

Keytruda Breaks New Ground with FDA Approval for Perioperative Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma

2 weeks ago talkbio0Tagged Adjuvant Therapy, Approved, Clinical Trials, Event-Free Survival, Gene Expression, KEYNOTE-689 trial, Keytruda, Neoadjuvant Therapy, PD-L1, pembrolizumab, perioperative, Squamous cell carcinoma of the head and neck, United States Food and Drug Administration

Keytruda; pembrolizumab; perioperative treatment; head and neck squamous cell carcinoma; HNSCC; FDA approval; KEYNOTE-689 trial; neoadjuvant therapy; adjuvant therapy; PD-L1 expression; event-free survival; clinical trial

FDA Delays Decision on Ascendis’ Dwarfism Drug by Three Months

2 weeks ago talkbio0Tagged Achondroplasia, Approved, Ascendis Pharma, CNP gene, Deferred, Dwarfism, navepegritide, PDUFA, post-marketing requirement, TransCon, United States Food and Drug Administration

FDA; Ascendis Pharma; TransCon CNP; navepegritide; achondroplasia; dwarfism; PDUFA; post-marketing requirement; delay; approval

Otsuka’s Anti-APRIL Antibody (Voyxact/Sibeprenlimab) Receives FDA Approval for IgA Nephropathy (IgAN)

2 weeks ago talkbio0Tagged anti-APRIL antibody, Approved, IGA Glomerulonephritis, Monoclonal Antibodies, Otsuka, Proteinuria, Sibeprenlimab, United States Food and Drug Administration, Voyxact

Otsuka; anti-APRIL antibody; Voyxact; sibeprenlimab; FDA approval; IgA nephropathy; IgAN; proteinuria; monoclonal antibody

Imfinzi Gains FDA Approval for Early Gastric and GEJ Cancers; BiomX Nebulizer Faces FDA Scrutiny

2 weeks ago talkbio0Tagged Approved, BiomX, Clinical, Imfinzi, Malignant neoplasm of cardioesophageal junction of stomach, Malignant neoplasm of stomach, Nebulizers, perioperative, United States Food and Drug Administration

Imfinzi; FDA approval; gastric cancer; gastroesophageal cancer; perioperative; BiomX; nebulizer; clinical hold

Dupixent Gains EU Approval as First Targeted Therapy for Chronic Spontaneous Urticaria in Over a Decade

2 weeks ago talkbio0Tagged Approved, Chronic Spontaneous Urticaria, Dupixent, EU, Interleukin-13, interleukin-4, Monoclonal Antibodies, Regeneron, sanofi, type 2 inflammation

Dupixent; chronic spontaneous urticaria (CSU); EU approval; Sanofi; Regeneron; monoclonal antibody; IL-4; IL-13; CUPID phase 3 trials; type 2 inflammation

FDA Approves Novartis’ Itvisma: Expanding Gene Therapy to Older Spinal Muscular Atrophy Patients

2 weeks ago talkbio0Tagged Adult, Approved, gene therapy, intrathecal formulation, Itvisma, Novartis, older children, Spinal Muscular Atrophy, United States Food and Drug Administration, Zolgensma

Novartis; FDA approval; Itvisma; Zolgensma; Spinal Muscular Atrophy (SMA); Gene Therapy; Older Children; Adults; Intrathecal Formulation

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