Organic Chemical – Page 3

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

3 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

ASH 2025: Breakthroughs in In Vivo CAR-T Data from Kelonia; Phase 3 Wins for Lilly, J&J, and Novartis

3 weeks ago talkbio0Tagged 2025, Asymmetric Septal Hypertrophy, CAR-T, CAR-T therapy, Eli Lilly, in vivo, Kelonia Therapeutics, Multiple Myeloma, Novartis, Phase 3 trials

ASH 2025; in vivo CAR-T; Kelonia Therapeutics; KLN-1010; multiple myeloma; Johnson & Johnson; Lilly; Novartis; CAR-T therapy; Phase 3 trials

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

3 weeks 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

Inhibikase Therapeutics Announces Pricing of $100 Million Public Offering of Common Stock and Pre-Funded Warrants

3 weeks ago talkbio0Tagged 4,4-difluoro-5,7-dimethyl-4-bora-3a,4a-diaza-3-indacene, Cantor, clinical-stage pharmaceutical, Inhibikase Therapeutics, Jefferies, pre-funded, Pricing, public entity

Inhibikase Therapeutics; public offering; common stock; pre-funded warrants; $100 million; Jefferies; BofA Securities; Cantor; clinical-stage pharmaceutical; pricing

EDAP Receives FDA 510(k) Clearance for Advanced Focal One Robotic HIFU System Enhancements

3 weeks ago talkbio0Tagged algorithm, Clearance, Edap, Malignant neoplasm of prostate, Medical Devices, robotic HIFU, United States Food and Drug Administration

EDAP; FDA 510(k) clearance; Focal One; robotic HIFU; high intensity focused ultrasound; ultrasound imaging; prostate cancer treatment; AI algorithms; medical devices

Novartis Raises Sales Targets for Key Cancer Drugs, Tweaks Yearly Growth Guidance

3 weeks ago talkbio0Tagged cancer drugs, Drug Industry, Kisqali, leukemia, Malignant neoplasm of breast, Novartis, peak sales, Pluvicto, sales guidance, Scemblix

Novartis; Kisqali; Scemblix; Pluvicto; sales guidance; peak sales forecast; cancer drugs; breast cancer; leukemia; pharmaceutical industry

Agios’ Sickle Cell Trial Falls Short as Mitapivat Fails to Significantly Reduce Pain Crises

3 weeks ago talkbio0Tagged Agios, Anemia, Sickle Cell, Clinical Trials, hemoglobin response, mitapivat, pain crises, Pyrukynd, Rise Up trial

Agios; mitapivat; Pyrukynd; sickle cell disease; pain crises; clinical trial; Rise Up trial; hemoglobin response

GSK and LTZ Therapeutics Announce $50M Partnership to Develop First-in-Class Myeloid Cell Engagers for Cancer

3 weeks ago talkbio0Tagged Biotechnology, engagers, hematologic cancers, Immunotherapy, letrozole, Myeloid Progenitor Cells, Neoplasms, preclinical programs, SmithKline Beecham, Solid Neoplasm, strategic collaboration, upfront

GSK; LTZ Therapeutics; myeloid cell engagers; oncology; hematologic cancers; solid tumors; immunotherapy; strategic collaboration; biotechnology; $50 million upfront; preclinical programs

US-Backed Group Reports Success with New Tuberculosis Treatment in Phase 2 Study

3 weeks ago talkbio0Tagged Clinical Trials, drug-resistant TB, linezolid, Phase 2 clinical trial, pretomanid, sorfequiline, SPaL, TB Alliance, Treatment Protocols, Tuberculosis, U.S., ultra-short regimen

tuberculosis; TB Alliance; Phase 2 clinical trial; sorfequiline; SPaL regimen; pretomanid; linezolid; drug-resistant TB; ultra-short regimen; US support; clinical trial results

FDA Pushes for Onshoring and Improved Data Fidelity in Generic Drug User Fee (GDUFA IV) Negotiations

3 weeks ago talkbio0Tagged bioequivalence, Data Fidelity, GDUFA IV, Manufacturing, Metric (substance), onshoring, Performance, public health medicine (field), United States Food and Drug Administration, user fee

FDA; onshoring; data fidelity; generic drugs; user fee; GDUFA IV; manufacturing; bioequivalence; public health; performance metrics