Approvals
Eli Lilly’s Jardiance scores expanded heart failure approval from the FDA and will now be available to all patients with heart failure to reduce the risk of death and hospitalization.
The FDA’s decision to approve Purdue’s drug Nalmefene earned mixed reactions, especially as the company is in the middle of lawsuits. Here’s what you need to know.
With IND approval, the therapeutics have become the first LBPs for Parkinson’s disease cleared by the FDA.
A new packaging and labeling manufacturing facility has derailed the potential approval of Malinckrodt’s investigational hepatorenal syndrome (HRS) treatment, terlipressin.
The end of February picks up significantly from early this year for the U.S. Food and Drug Administration and its PDUFA dates.
Bayer is heading back to the FDA to seek approval for a new indication of its prostate cancer drug Nubeqa, following positive Phase III results.
The FDA has approved Agios Pharmaceuticals’ Pyrukynd for a rare type of hemolytic anemia treatment. Continue reading the article to know more about the new drug.
It’s not clear if the recent deaths reported in FAERS resulted from the patients taking Aduhelm. This article takes a deep dive into this controversy.
In April 2021, the U.S. Food and Drug Administration issued Acadia a Complete Response Letter (CRL) related to its previous attempt to expand the approved indication for Nuplazid.
The FDA will evaluate AMX0035, an investigational oral fixed-dose drug intended for people diagnosed with ALS.
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