By Chris Wack Amneal Pharmaceuticals shares were up 9% after the Food and Drug Administration approved an abbreviated new drug application ...
The FDA has approved Amneal Pharmaceuticals’ ( NASDAQ: AMRX) OTC Naloxone HCl nasal spray, a generic version of the opioid ...
"The FDA is committed to fostering new antibiotic availability when they prove to be safe and effective, and Zevtera will provide an additional treatment option for a number of serious bacterial ...
HER2 is a protein that stimulates quick growth of cancer cells. Its presence in solid tumor form includes biliary tract, bladder, cervical, endometrial, ovarian and pancreatic cancers, according to ...
The US Food and Drug Administration on Friday allowed the expanded use of Johnson and Johnson Legend Biotech's Carvykti cell therapy as an earlier treatment for patients with a type of blood cancer.
The FDA has approved Janssen/Johnson & Johnson’s Carvykti (ciltacabtagene autoleucel) for use as earlier treatment in patients who have relapsed/refractory multiple myeloma (RRMM) that is ...
Enhertu has been approved by the FDA for certain patients with unresectable or metastatic HER2-positive solid tumors. The Food and Drug Administration has granted Enhertu (fam-trastuzumab ...
US FDA Approves Daiichi, AstraZeneca Drug for Treatment of Solid Tumors (Reuters) - The U.S. Food and Drug Administration on Friday gave accelerated approval for the expanded use of Daiichi Sankyo ...
Abecma had previously been approved by the FDA for patients who received at least four prior lines of therapy. The approval, based on findings from the phase 3 KarMMa-3 trial, makes Abecma earlier for ...
Due to adcomm panel meet, the FDA pushed the approval date for Abecma from 16 December 2023. Abecma helped extend the time before disease progression by 13.3 months vs. 4 months in standard care ...
The US Food and Drug Administration (FDA) has approved the first-ever prescription app for major depressive disorder (MDD). The app, Rejoyn, was developed by Otsuka Pharmaceutical and Click ...
On April 3, 2024 FDA approved Zevtera (ceftobiprole medocaril sodium for injection) as a treatment for three types of bacterial infections: adults with Staphylococcus aureus bloodstream infections ...