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Bluebird Bio is pulling out all the regulatory stops for its investigational sickle cell disease (SCD) gene therapy lovotibeglogene autotemcel (lovo-cel), submitting a BLA with a request for priority review in addition to the four expedited approval designations the FDA had already granted the drug. Read More
Genentech has won full approval for its first-in-class combination therapy aimed at providing curative treatment for patients with previously untreated diffuse large B-cell lymphoma (DLBCL), the most common form of non-Hodgkin lymphoma in the U.S. Read More
Before the passage of the Orphan Drug Act (ODA) in 1983, the logistical challenges and financial downsides of developing a drug for a very small population affected by a rare disease meant few drugs on the horizon. Read More
The FDA has approved Omisirge (omidubicel-onlv), Gamida Cell’s first-in-class allogeneic umbilical cord-blood stem cell treatment for blood cancers, which carries a unique twist that increases their immune-boosting potential. Read More
Alvotech has drawn an FDA Complete Response Letter (CRL) for manufacturing facility deficiencies in its BLA for AVT02, a biosimilar candidate for AbbVie’s mega-blockbuster anti-inflammatory therapy Humira (adalimumab). Read More
A joint FDA advisory committee has cleared the way for Otsuka and Lundbeck’s Rexulti (brexpiprazole) as a new treatment for dementia-related agitation. Read More
The FDA offers several pathways to expedite approval of new drugs to help get them to market much more quickly while still evaluating their safety. Read More
New FDA drug approvals in the past month include treatments for rare diseases and an aggressive form of skin cancer, as well as the first new treatment for invasive fungal infections in over a decade. Additionally, the FDA approved a new device for use in patients with arterial occlusive disease. Read More
AbbVie and Johnson & Johnson (J&J) are voluntarily withdrawing accelerated approval for their blockbuster oncology drug Imbruvica (ibrutinib) for two blood cancers following disappointing confirmatory trial results. Read More