Qualitative Concept – Page 5

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

2 months 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

Recent Developments in Medical Affairs Reputation and Hemophilia A Management in the US (2025)

2 months ago talkbio0Tagged Acquired (qualifier value), Centers for Disease Control and Prevention (U.S.), federal funding, gene therapy, Health Policy, Hemophilia A, Hemophilia A Pipeline, Hemophilia Treatment Centers, HRSA, Medical Affairs, Programs - Publication Format, public health policy, reputation, U.S.

Medical Affairs; Reputation; Hemophilia A; US; 2025; Gene Therapy; Public Health Policies; Hemophilia Treatment Centers; 340B Program; Federal Funding; Acquired Hemophilia A Pipeline; Healthcare Policy; CDC; HRSA

FDA Delays Decision on Ascendis’ Dwarfism Drug by Three Months

2 months 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 months 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 months 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

CMS Unveils Negotiated Prices for Ozempic, Wegovy, and Other Drugs in Second Round of IRA Talks

2 months ago talkbio0Tagged drug price, Effectiveness, Inflation Reduction Act, Medicare Part D, Myasthenic Syndromes, Congenital, negotiation, Ozempic, Prices, semaglutide, Wegovy

CMS; Ozempic; Wegovy; Inflation Reduction Act; drug price negotiation; Medicare Part D; semaglutide; negotiated prices; 2027 effective date

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

2 months 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 months 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

2 months 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

Aspen Neuroscience Secures $115 Million Series C to Advance Parkinson’s Cell Therapy; IPO Considered for 2026

2 months ago talkbio0Tagged Aspen, Bach Flower Essence, Autologous (qualifier value), Cell Therapy, Clinical Trials, Induced Pluripotent Stem Cells, IPO, manufacturing scale-up, Neuroscience discipline, Parkinson 's disease, plans, Regenerative Medicine, Series C financing

Aspen Neuroscience; Series C financing; Parkinson’s disease; cell therapy; ANPD001; autologous iPSC; clinical trials; manufacturing scale-up; IPO plans; regenerative medicine