Approvals
However, a lack of regulatory harmonization risks undermining the effective implementation of these technology-driven approaches.
Bristol Myers Squibb announced Monday that Reblozyl is now approved as a first-line treatment for adults with anemia due to myelodysplastic syndromes who may require regular blood transfusions.
A second trial shows Novo Nordisk’s Wegovy improves heart health. Meanwhile, many other drugs are beginning to face generic competition, including from newly approved biosimilars.
Amid one of the industry’s steepest patent cliffs, the regulator Thursday approved Sandoz’s Tyruko, the first biosimilar for treating relapsing multiple sclerosis in adults. Sandoz is a division of Novartis.
In the next two weeks, the FDA will hand out regulatory verdicts to BMS, Outlook Therapeutics and BioLineRx.
As the new executive VP and chief development officer of BrainStorm, Dagher is tasked with securing FDA approval of NurOwn for the treatment of ALS.
The FDA on Monday gave the greenlight to Pfizer’s RSV vaccine for expectant mothers, given during the third trimester of pregnancy, designed to protect newborn babies through the first six months of life.
Following a prior rejection due to manufacturing problems, Regeneron’s higher-dose Eylea won the FDA’s approval Friday, allowing for more infrequent dosing for the treatment of various eye diseases.
The regulator’s greenlight on Friday for Regeneron Pharmaceuticals’ monoclonal antibody Veopoz (pozelimab) makes it the first and only treatment indicated for children and adults with CHAPLE disease.
Boehringer Ingelheim will launch three Phase III studies for its obesity drug candidate; third time is a charm for Ipsen as it gets FDA approval; and Pfizer takes multiple myeloma battle to J&J.
PRESS RELEASES