FDA shakes up weight loss market as Mounjaro shortage ends
Federal regulators shook up the booming weight loss drug marketplace when they announced Mounjaro and Zepbound to be no longer in shortage after nearly two years. Pharmacies that sold ...
STAT2d
In stark reversal, FDA to reconsider removal of Eli Lilly weight loss drug from shortage list
The FDA, in a stark reversal, on Friday said it would reconsider its decision to remove Eli Lilly’s tirzepatide from its ...
US FDA to reconsider decision barring compounded versions of Lilly weight loss drug
The U.S. Food and Drug Administration on Friday agreed to reconsider its recent decision barring drug compounders from ...
The American Journal of Managed Care2d
FDA Approves Imuldosa, a Fifth Biosimilar to Stelara
Imuldosa (ustekinumab-srlf) is the fifth ustekinumab biosimilar referencing Stelara to receive regulatory approval in the US.
Pfizer’s Hympavzi Approved for Treatment of Certain Types of Hemophilia
The FDA approved Pfizer’s Hympavzi, which can be an alternative to intravenous infusions often administered multiple times a ...
Pfizer wins FDA approval for hemophilia B drug that will be first once-weekly treatment
The new drug would allow patients to produce the needed clotting protein for an extended period, reducing the need for ...
Business Wire2d
US FDA Approves Dong-A ST’s IMULDOSA™ (ustekinumab-srlf), a Biosimilar to STELARA
FDA approves the biologics license application (BLA) that Dong-A submitted in 2023 for Imuldosa, a biosimilar referencing Stelara.
US FDA approves Pfizer's drug for rare bleeding disorder
The U.S. Food and Drug Administration approved Pfizer's once-a-week injection for the two main types of a rare bleeding ...
MassDevice2d
Astellas subsidiary Iota wins FDA IDE nod to study implantable bladder device
Iota Biosciences, anAstellas subsidiary, announced that it received FDA investigational device exemption (IDE) for its ...
Becker's Hospital Review4d
FDA approves 1st combination COVID-flu test: 4 things to know
The FDA reported that the test accurately identified 99% of negative COVID-19 samples and 92% of positive samples. For the flu, the test showed 99.9% accuracy for negative samples and 92.5% and 90.5% ...