Business Wire

Ifinatamab Deruxtecan Granted Breakthrough Therapy Designation by U.S. FDA for Patients with Pretreated Extensive-Stage Small Cell Lung Cancer

Data from IDeate-Lung01 trial will be presented at upcoming IASLC 2025 World Conference on Lung Cancer First Breakthrough Therapy Designation for Daiichi Sankyo and Merck’s ifinatamab deruxtecan based ...
Ibj.com

Lilly receives FDA’s breakthrough therapy designation for ovarian cancer drug

Eli Lilly and Co. has received the U.S. Food and Drug Administration’s breakthrough therapy designation for a drug in development to treat certain ovarian cancer patients. The Indianapolis-based ...

FDA Grants Orchestra BioMed Additional Breakthrough Device Designation for AVIM Therapy

Therapy Food and Drug Administration (“FDA”) Breakthrough Device Designations span the broader population of patients with uncontrolled hypertension despite medication at increased cardiovascular risk ...
Monthly Prescribing Reference

Rinatabart Sesutecan Designated Breakthrough Therapy for Advanced Endometrial Cancer

Findings showed in the rinatabart sesutecan 100mg/m 2 cohort, the confirmed ORR was 50%, with 2 patients achieving complete response. The Food and Drug Administration (FDA) has granted Breakthrough ...

Jaguar Health stock surges on FDA breakthrough discussions for rare disease therapy

Jaguar Health Inc JAGX shares are climbing Wednesday morning. The momentum follows the company’s announcement of preliminary ...
Yahoo Finance

Terns Pharmaceuticals Announces FDA Breakthrough Therapy Designation Granted to TERN-701 for Certain Patients with Chronic Myeloid Leukemia

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Healio

FDA grants breakthrough designation for litifilimab in cutaneous lupus

Please provide your email address to receive an email when new articles are posted on . FDA has granted breakthrough designation for litifilimab in patients with cutaneous lupus erythematosus. The ...
Business Wire

Innate Pharma Announces U.S. FDA Granted Breakthrough Therapy Designation to Lacutamab for Relapsed or Refractory Sézary Syndrome

MARSEILLE, France--(BUSINESS WIRE)--Regulatory News: Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) ...
The American Journal of Managed Care

Bepirovirsen for Chronic Hepatitis B Receives Breakthrough Therapy Designation, Priority Review

FDA regulatory momentum includes priority review and breakthrough therapy designation for a potential first-in-class CHB ...

Terns Pharmaceuticals Gets Breakthrough Designation for Leukemia Treatment

Terns Pharmaceuticals said it received a breakthrough therapy designation from U.S. regulators for its leukemia treatment. The Food and Drug Administration granted the designation to TERN-701, which ...
Taiwan News

Clearmind Medicine Announces Evaluation of its Psychedelic-Based Treatment (MEAI) for Potential FDA Breakthrough Therapy Designation

Clearmind Medicine Inc. (Nasdaq: CMND) (“Clearmind” or the "Company"), a clinical-stage biotech company focused on the discovery and development of novel, non-hallucinogenic, second generation, ...