The U.S. Food and Drug Administration’s approval-review schedule for August includes the Biologics License Application for Bristol Myers Squibb and Juno Therapeutics’ lisocabtagene maraleucel (liso-cel) for relapsed or refractory large B-cell lymphoma after at least two previous therapies.
The U.S. Food and Drug Administration and Health Canada approved Inqovi (decitabine and cedazuridine) tablets as the first orally administered hypomethylating agent for the treatment for adults with intermediate and high-risk myelodysplastic syndromes (MDS).
The U.S. Food and Drug Administration approved Seattle Genetics’ Tukysa (tucatinib) in combination with chemotherapy agents trastuzumab and capecitabine for adults with HER2+ breast cancer that cannot be surgically removed or has metastasized to other parts of the body.
Vivek Ramaswamy’s Roivant Sciences has launched another “vant” company, this time in China, in a partnership with Hong Kong-based Sinovant Sciences.
Tricida reported that it closed an oversubscribed Series D financing worth $57.5 million. The round brings the company’s total capital raised to $153.5 million.
Boehringer Ingelheim announced that the supplemental New Drug Application for Gilotrif (afatinib) was accepted for filing and granted Priority Review by the U.S. Food and Drug Administration.
The U.S. FDA turned down Acorda Therapeutics’ New Drug Application for Inbrija, which was being evaluated for OFF periods in Parkinson’s disease.
Shares of Paratek rocketed upward after the antibiotics specialist posted a “for sale” sign on the doors.
Although the dust may have settled from a Canadian lawsuit Eli Lilly lost over patents for two of its drugs, Zyprexa and Strattera, questions remain over the manner in which the Indianapolis-based company fought in court.
Feb. 12, 2018, is the day the U.S. FDA is expected to review Gilead Sciences’ HIV treatment that some analysts suggest could become a blockbuster.