Approved – Page 2

Boehringer Ingelheim breaks into oncology as FDA grants accelerated approval to Hernexeos (zongertinib) for HER2 TKD–mutated NSCLC

2 weeks ago talkbio0Tagged Accelerated, Approved, Beamion, Boehringer Ingelheim, competition, Confirmatory Trial, Enhertu, erbB-2 Receptor, Frequency of Responses, HER2-mutant, Hernexeos, Identifier, LUNG-1, Mutation, Non-Small Cell Lung Carcinoma, non-squamous NSCLC, Oncomine Dx Target Test, oral targeted therapy, Priority Review, Requirement, TKD, United States Food and Drug Administration, Zongertinib

Boehringer Ingelheim; Hernexeos; zongertinib; FDA approval; accelerated approval; non-squamous NSCLC; HER2 TKD mutations; Oncomine Dx Target Test; Beamion LUNG-1; objective response rate; first oral targeted therapy for HER2-mutant NSCLC; priority review; breakthrough therapy designation; confirmatory trial requirement; competition with Enhertu

AbbVie and Genmab Move to Expand Use of T Cell Engager Epkinly Following Strong Phase III Results

3 weeks ago talkbio0Tagged AbbVie, Antibodies, Bispecific, Approved, Epcoritamab, EPKINLY, expansion, Genmab, Labels (device), lenalidomide, Lymphoma, Follicular, Phase 3 Clinical Trials, rituximab, T-Cell engager, United States Food and Drug Administration

Epkinly; epcoritamab; AbbVie; Genmab; follicular lymphoma; T cell engager; bispecific antibody; Phase III trial; FDA approval; label expansion; Rituximab; Lenalidomide

FDA Grants Accelerated Approval to Jazz’s Dordaviprone (Modeyso), the First Treatment for Ultra-Rare Brain Tumor

3 weeks ago talkbio0Tagged Accelerated, Approved, Brain Neoplasms, Chimerix acquisition, Confirmatory Trial, Dordaviprone, midline glioma, Modeyso, pediatric brain cancer, United States Food and Drug Administration

Dordaviprone; Modeyso; FDA approval; H3 K27M-mutant diffuse midline glioma; ultra-rare brain tumor; Jazz Pharmaceuticals; accelerated approval; pediatric brain cancer; Chimerix acquisition; confirmatory trial

Vertex Drops Next-Generation Pain Drug After Phase 2 Failure, Casts Doubt on Broader Journavx Expansion

3 weeks ago talkbio0Tagged Acute onset pain, Approved, Drug Development, Journavx, non-opioid pain drugs, Pain management, Peripheral neuropathic pain, Sodium Channel Blockers, United States Food and Drug Administration, VX-993

Vertex Pharmaceuticals; Journavx; VX-993; pain management; acute pain; phase 2 clinical trial; sodium channel inhibitor; non-opioid pain drugs; FDA approval; peripheral neuropathic pain; drug development

Replimune Awaits FDA Direction After Complete Response Letter for Advanced Melanoma Therapy

3 weeks ago talkbio0Tagged Accelerated, Advanced Melanoma, Approved, Cancer Therapeutic Procedure, Complete, IGNYTE trial, nivolumab, Replimune, Response Letter, RETINITIS PIGMENTOSA 1, United States Food and Drug Administration, vusolimogene oderparepvec

Replimune; FDA; Complete Response Letter; RP1; vusolimogene oderparepvec; nivolumab; advanced melanoma; cancer treatment; IGNYTE trial; accelerated approval

FDA Approves LENZ Therapeutics’ VIZZ Eye Drop for Presbyopia

4 weeks ago talkbio0Tagged aceclidine, Approved, Eye Drops, LENZ, Myopia, presbyopia, United States Food and Drug Administration, VIZZ

FDA approval; VIZZ; LENZ Therapeutics; presbyopia; aceclidine; eye drop; near vision

Apellis’ Empaveli Gains FDA Approval for Broad C3 Glomerulopathy Use, Setting Up Competition with Novartis’ Fabhalta

4 weeks ago talkbio0Tagged Apellis, Approved, C3 glomerulopathy, Empaveli, Fabhalta, Iptacopan, Kidney Diseases, membranoproliferative glomerulonephritis, Novartis, pegcetacoplan, Proteinuria, United States Food and Drug Administration

Apellis; Empaveli; FDA approval; C3 glomerulopathy; primary immune complex membranoproliferative glomerulonephritis; Novartis; Fabhalta; pegcetacoplan; iptacopan; proteinuria; kidney disease

LEO Pharma Scores FDA Approval for Anzupgo as First Treatment for Chronic Hand Eczema

1 month ago talkbio0Tagged Anzupgo, Approved, Chechen language, chronic hand eczema, delgocitinib, pan-JAK inhibitor, Pharma, topical treatment, United States Food and Drug Administration

LEO Pharma; Anzupgo; delgocitinib; FDA approval; chronic hand eczema; pan-JAK inhibitor; moderate-to-severe CHE; topical treatment

FDA Rejects Roche’s Columvi for Earlier-Line Diffuse Large B-Cell Lymphoma

1 month ago talkbio0Tagged Accelerated, Approved, Columvi, Complete, Diffuse Large B-Cell Lymphoma, gemcitabine, genentech, oxaliplatin, Rejection, Response Letter, Roche (company), second, second-line treatment, STARGLO, Third line treatment, United States Food and Drug Administration

FDA rejection; Columvi; Roche; Genentech; diffuse large B-cell lymphoma; DLBCL; STARGLO study; second-line treatment; Complete Response Letter; gemcitabine; oxaliplatin; accelerated approval; third-line therapy

FDA Declines Approval of Ultragenyx’s Sanfilippo Gene Therapy Due to Manufacturing Issues

1 month ago talkbio0Tagged Approved, gene therapy, manufacturing issues, Mucopolysaccharidosis Type IIIA, Regulatory Setback, Response Letter, Ultragenyx, United States Food and Drug Administration, UX111

FDA; Ultragenyx; Sanfilippo syndrome type A; gene therapy; manufacturing issues; UX111; regulatory setback; complete response letter; approval delay