FDA sign

The U.S. Food and Drug Administration issued a partial clinical hold for Foghorn Therapeutics’ Phase I clinical study, investigating the safety and efficacy of FHD-286 in patients with relapsed and/or refractory acute myelodysplastic leukemia (AML) and myelodysplastic syndromes (MDS). The hold follows a serious adverse event in which a study participant died after developing possible differentiation syndrome.

Magenta Therapeutics is reducing the company’s workforce by 14 percent in a revised operating plan to prioritize research and development.

The American Association for Cancer Research (AACR) Annual Meeting is running from April 7-13 in New Orleans, with hundreds of presentations on cutting-edge cancer research. The presentations run the gamut from preclinical studies to late-stage clinical trials. BioSpace looks at some of the preclinical and early-stage studies presented.

Gilead Sciences Inc. said on April 11 the U.S. Food and Drug Administration had lifted the partial clinical hold placed on the company’s trials testing a blood cancer drug combination.

Shares of MEI Pharma Inc. plunged more than 60% in trading on March 25 after the company announced that additional clinical research will be needed in order for the its phosphatidylinositol-3-kinase (PI3K) inhibitor zandelisib to be considered for regulatory approval.

Bristol Myers Squibb’s blockbuster cancer drug Revlimid finally has a competitor as Teva Pharmaceuticals announced the launch of a generic version of Revlimid, which could significantly cut into the global biopharmaceutical company’s earnings.

A U.S. patient with leukemia has become the first woman and the third person to date to be cured of HIV after receiving a stem cell transplant from a donor who was naturally resistant to the virus that causes AIDS, researchers reported on February 15.

The U.S. Food and Drug Administration is investigating a possible death risk for TG Therapeutics’ Ukoniq (umbralisib), which is indicated for two types of lymphoma.

Temps are falling and so is investor cash as BioSpace reviewed which biotech companies are scooping up the dollars.

Incyte Corporation withdrew the New Drug Application (NDA) for the company’s candidate drug for various types of lymphoma.