Regeneron Pharmaceuticals said the U.S. FDA has declined approval for its blood cancer therapy for two forms of lymphoma, raising concerns over the progress of ongoing confirmatory trials.
Tag Archive for: FDA
The combo pill is indicated for chronic use in pulmonary arterial hypertension (PAH) patients falling under the World Health Organization’s functional classes II to III. These classes include patients who may have no symptoms at rest but experience shortness of breath or discomfort during normal activities such as climbing stairs or running errands.
The full approval makes Elahere the “first and only antibody-drug conjugate (ADC) approved in the U.S. for” ovarian cancer, a “difficult-to-treat malignancy,” AbbVie CMO of global therapeutics Roopal Thakkar, said in a statement.
The oral drug, to be sold under the brand name Duvyzat, is the first nonsteroidal drug approved to treat patients with all genetic variants of DMD, according to the FDA.
Yesterday the agency classified the recall of privately held Vyaire Medical’s respiratory support devices as most serious and said their use could cause major injuries or death.
Takeda secured another label expansion for the kinase inhibitor, this time in the first-line setting for the treatment of Philadelphia chromosome-positive acute lymphoblastic leukemia.
The FDA’s busy March continues with six target action dates remaining on the calendar. Over the next two weeks, the regulator will decide on investigational therapies for Duchenne muscular dystrophy, chronic kidney disease anemia, a rare metabolic disorder and more.
Yesterday’s approval comes months after Novartis turned its back on tislelizumab, returning global rights to BeiGene. The companies signed a collaboration contract for tislelizumab in January 2021, but ran into several regulatory roadblocks.
The drug was approved under the accelerated approval pathway, which allows for earlier approval of drugs that treat serious conditions and address an unmet medical need, based on a surrogate or intermediate clinical endpoint that is reasonably likely to predict clinical benefit.
The FDA approved Bristol Myers Squibb’s Breyanzi for chronic lymphocytic leukemia and small lymphocytic leukemia prior to Friday’s adcomm for the company’s other CAR-T therapy, Abecma.
