FDA
The South Korean company’s Epysqli is now FDA-approved for paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome in the U.S., having grabbed the lead in the Soliris biosimilar market in Europe.
FEATURED STORIES
New FDA expert panels, such as recent meetings on SSRI use during pregnancy and on hormone replacement therapy during menopause, are drawing criticism for being one-sided. One leader says such panels are designed to reach a specific conclusion.
Amid an unprecedented turnover in leadership at the FDA and mass layoffs of staff, communication has crumbled and uncertainty runs rampant, leaving small and medium biopharma companies without a clear path forward for their therapies.
Aside from the rare disease market, Novo Nordisk also scored a key regulatory win last month for its blockbuster GLP-1 drug Wegovy, which can now be used to treat patients with metabolic dysfunction-associated steatohepatitis.
Subscribe to ClinicaSpace
Clinical trial results, research news, the latest in cancer and cell and gene therapy, in your inbox every Monday
THE LATEST
The companies on Wednesday secured the regulator’s approval for their eye drop Ryzvumi for the reversal of pharmacologically-induced mydriasis, as Viatris looks to add $1 billion in sales by 2028.
The FDA on Monday approved the Canadian biopharma’s liquid antibiotic metronidazole, an alternative for patients who are unable to use pills or injections.
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.