Food and Drug Administration (FDA)
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As COVID-19 infections continue to increase in the U.S., the FDA has expanded the EUA for Eli Lilly’s monoclonal antibody to include treatment with or without remdesivir.
Semglee was approved under the FDA’s 351(k) pathway, a biologics license application process. It ensures that the bio similarity is based on animal studies, clinical trials, and analytical studies.
Several biotech and biopharmaceutical companies have announced new wins with the U.S. Food and Drug Administration (FDA), with these wins ranging from Investigational New Drug (IND) application approvals for cancer treatment candidates to Fast Track Designations for investigational agents aimed toward opioid use disorder (OUD).
One of the eagerly anticipated presentations at the AAIC being held this week is Biogen and its partner Eisai on their controversial drug ADUHELM™ (aducanumab). Biogen is also presenting new data on a different Alzheimer’s drug with another partner, Ionis Pharmaceuticals.
Merck’s Keytruda won FDA approval for the treatment of patients with high-risk, early-stage triple-negative breast cancer. The approval marked the 30th for Keytruda.
Bristol Myers Squibb (BMS) announced Friday its decision to withdraw from the U.S. market the indication for its immune checkpoint inhibitor Opdivo® (nivolumab) as monotherapy for hepatocellular carcinoma (HCC) in patients previously treated with sorafenib.
It’s a busy week for GlaxoSmithKline, although much of it is related to the upcoming demerger of its Consumer Healthcare business. Here’s a look.
The FDA called for Iterum to conduct an additional clinical study that uses a different drug for comparison and to determine optimal dosing.
The FDA’s ODAC met to discuss retifanlimab and voted 13-4 that a regulatory decision for the drug for this indication should be deferred until more data was available.
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