Hinova Pharmaceuticals’ HP518 gets FDA fast track designation in triple-negative breast cancer

Hinova Pharmaceuticals’ HP518 gets FDA fast track designation in triple-negative breast cancer

Hinova Pharmaceuticals Inc. (688302.SH), a trailblazer in the biopharmaceutical industry, has achieved a significant milestone with the U.S. Food and Drug Administration (FDA) granting Fast Track designation to its investigational drug, HP518. This drug is being developed specifically for the treatment of Androgen-receptor positive (AR+) triple-negative breast cancer (TNBC), a notably aggressive subtype of breast […]

Zentalis Pharmaceuticals reports promising results from Phase 1 trial of azenosertib, gemcitabine combo

Zentalis Pharmaceuticals reports promising results from Phase 1 trial of azenosertib, gemcitabine combo

Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), a trailblazer in developing small molecule therapeutics for cancer, has released the final results of its Phase 1 trial combining azenosertib with gemcitabine for relapsed or refractory osteosarcoma. The study findings, presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, showcased a notable improvement in […]

PharmaMar’s lurbinectedin granted orphan drug designation by FDA for small cell lung cancer treatment

PharmaMar’s lurbinectedin granted orphan drug designation by FDA for small cell lung cancer treatment

Spanish pharmaceutical company PharmaMar has announced that its cancer drug, lurbinectedin, has received orphan drug designation from the US Food and Drug Administration (FDA) for the treatment of small cell lung cancer (SCLC). This designation marks a critical milestone in the development of lurbinectedin, highlighting its potential in treating this aggressive form of cancer. Lurbinectedin […]

India’s CDSCO grants APAC Biotech license for immuno-oncology drug Apceden

The Indian FDA (CDSCO - Central Drugs Standard Control Organization) has granted a commercial license to APAC Biotech to market Apceden, a Dendritic cell-based autologous Immuno-oncology drug for prostate, ovarian, colo-rectal and non small cell lung carcinoma form of cancers.

India’s CDSCO grants APAC Biotech license for immuno-oncology drug Apceden

The Central Drugs Standard Control Organization (CDSCO), India’s regulatory authority, has granted a commercial license to APAC Biotech for the marketing of Apceden, a Dendritic cell-based autologous immuno-oncology drug. This approval marks a significant advancement in the treatment of various cancer types, including prostate, ovarian, colorectal, and non-small cell lung carcinoma. Pioneering Cancer Therapy Approved […]