Lynozyfic wins FDA accelerated approval for treating RRMM adults
Linvoseltamab, now branded as Lynozyfic, has received accelerated approval from the U.S. Food and Drug Administration (FDA) for treating adults with relapsed or refractory…
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SENTI-202 granted FDA orphan drug designation for blood cancers
Senti Biosciences‘ experimental cell therapy SENTI-202 has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) as a potential therapy…
GLIX1 named FDA orphan drug as potential malignant glioma therapy
The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to GLIX1, a cancer treatment now in the preclinical stages of development, as…
Trial of BAT8006 for form of ovarian cancer doses 1st patient
The first patient has been dosed in a Phase 3 trial testing the investigational therapy BAT8006 in people with platinum-resistant ovarian cancer, according to the…
EU panel backs 1st-line Sarclisa for transplant-eligible myeloma
A European Medicines Agency committee has recommended that Sarclisa (isatuximab), used in combination with standard-of-care medications, be approved for the treatment of adults newly…
Revuforj gets FDA priority review for AML with NPM1 mutations
U.S. regulators have granted priority review to Syndax’s application to extend the approval of Revuforj (revumenib) to treat relapsed or refractory acute myeloid leukemia (AML)…
Medicovestor’s pancreatic cancer therapy named FDA orphan drug
The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to ADoBind MC001, an experimental treatment for pancreatic cancer that’s being developed…
Reyobiq trial for high-grade pediatric glioma approved by FDA
Reyobiq (Rhenium Re186 Obisbemeda), an experimental radiation therapy being developed by Plus Therapeutics, has been cleared by the U.S. Food and Drug Administration (FDA)…
Ovarian cancer immunotherapy found to boost immune response
IMNN-001, Imunon’s experimental immunotherapy for advanced ovarian cancer, boosts the body’s natural immune response by increasing levels of immune signaling proteins that aid in…
EU panel backs Darzalex for high-risk smoldering multiple myeloma
A European Medicines Agency (EMA) committee recommended that Darzalex (daratumumab) given as an under-the-skin injection be approved for people with smoldering multiple myeloma (SMM)…
