FP008 is designed for patients with solid tumors that have not responded to existing immunotherapies targeting PD-1.

The U.S. Food and Drug Administration (FDA) has approved Fapon Biopharma’s Investigational New Drug (IND) application for ...

The US Food and Drug Administration has accepted Sobi’s supplemental biologics licence application for Gamifant ...

The positive CHMP opinion is supported by data from the pivotal LINKER-MM1 trial, which evaluated linvoseltamab in adults with R/R MM. Earlier this month, the FDA accepted for review the Biologics ...

Pharmaceuticals announced that the European Medicines Agency’s, EMA, Committee for Medicinal Products for Human Use, CHMP, has ...

Fapon Biopharma, a biotech innovator in developing therapeutic antibodies and fusion proteins, is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved the Investigational ...

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human ...

US FDA grants priority review to Sobi’s sBLA for Gamifant for use in adult and paediatric patients with HLH/MAS in Still’s disease: Stockholm Friday, February 28, 2025, 09:00 ...

Regeneron on Friday said the recommendation covers adults with adults with relapsed and refractory multiple myeloma who have received at least three prior therapies, including a proteasome inhibitor, ...

Roche (OTCQX:RHHBY) said the European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended ...

Rare Disease Day, an annual gathering hosted by the FDA and National Institutes of Health, was postponed. Medicare spending on 10 diabetes drugs, including popular GLP-1s, more than quadrupled over a ...

Following a flurry of activity at this month’s meeting of the European Medicines Agency’s Committee for Medicinal Products ...