Approvals
ARS Pharmaceuticals, Intarcia Therapeutics and Taysha Gene Therapies this week got stark reminders of the difficulties in getting treatments through the regulator’s approval process.
Following a regulatory victory for Jemperli in endometrial cancer last month, GSK continued its oncology winning streak with an FDA approval for momelotinib in adult myelofibrosis patients with anemia.
The FDA will finish September with three action dates and one of the year’s most highly-anticipated advisory committee meetings.
The regulator Monday approved the companies’ supplemental Biologics License Applications for their respective mRNA shots formulated to more closely target currently circulating variants.
Amid a supply shortage of the attention-deficit/hyperactivity disorder and binge-eating disorder medication, the regulator has cleared a slew of generic drugs of Takeda’s Vyvanse pill.
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.
PRESS RELEASES