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.
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.
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.
Roivant Sciences launched the new subsidiary Hemavant, which hit the ground running with a licensing agreement from Eisai for RVT-2001, a potential first-in-class small molecule SF3B1 modulator.
The U.S. Food and Drug Administration placed a partial clinical hold on studies conducted by Gilead Sciences assessing the combination of magrolimab plus azacitidine due to concerns of unexpected serious adverse events between study arms.
Japanese biopharmaceutical firm Takeda Pharmaceutical announced that the company’s drug candidate for leukemia failed to meet the primary endpoint in a late-stage study.
Dr. Reddy’s Laboratories Ltd. along with the company’s subsidiaries announced that Reddy-Lenalidomide, a generic equivalent to Revlimid (lenalidomide) capsules, was approved by Health Canada and launched in the Canadian market.
The U.S. Food and Drug Administration placed a clinical hold on Boston-based Aprea Therapeutics’ lymphoid malignancy trial after the regulatory agency expressed concerns regarding the safety and efficacy data from a previous myelodysplastic syndromes (MDS) study.
Shares of bluebird bio were down more than 24 percent after the company announced that the U.S. Food and Drug Administration placed a clinical hold on studies of the gene therapy elivaldogene autotemcel (eli-cel) for cerebral adrenoleukodystrophy (CALD).
The U.S. Food and Drug Administration greenlit the classification of California-based biotechnology firm Genentech’s Venclexta (venetoclax) and azicitidine combination as a Breakthrough Therapy Drug.