The Globe and Mail14d
U.S. FDA approves injectable version of cancer drug from Bristol Myers Squibb
The U.S. Food and Drug Administration said on Friday that it has approved an injectable version of Bristol Myers Squibb’s BMY-N blockbuster cancer drug, Opdivo. Opdivo is part of a class of ...
New York Post17d
FDA approves Hikma’s generic version of Novo’s diabetes drug Victoza
Hikma said on Monday it was “pleased to have FDA approval to launch this important medicine and to provide broader access and greater affordability for the patients who rely on it”.
WebMD18d
FDA Approves Zepbound for Obstructive Sleep Apnea
Dec. 23, 2024 -- The FDA has approved the first prescription drug, Zepbound, for treating moderate to severe obstructive sleep apnea (OSA) in adults with obesity. Studies have shown that when ...
Pharm Exec18d
FDA Grants Accelerated Approval to Pfizer’s Braftovi Combination for Metastatic Colorectal Cancer
Accelerated approval was based on promising results from the ongoing Phase III BREAKWATER trial. The FDA has granted accelerated approval to Pfizer’s Braftovi (encorafenib) in combination with ...
BioSpace18d
U.S. FDA Approves Pfizer’s BRAFTOVI® Combination Regimen as First-Line Treatment of BRAF V600E-Mutant Metastatic Colorectal Cancer
BRAFTOVI ® (encorafenib) is indicated, in combination with cetuximab and mFOLFOX6, for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an ...
The Taipei Times19d
Biden approves US$571m Taiwan aid
US President Joe Biden on Friday agreed to provide US$571.3 million in defense support for Taiwan, the White House said, while the US State Department approved the potential sale of US$265 million in ...
New Atlas20d
"100% successful" cancer drug gets landmark FDA approval
the FDA received 1,516 requests for this designation, and only 587 have been granted. This is in line with previous years, during which around 30-40% of requests have been approved. Dostarlimab ...
The New York Times20d
Transition Updates: Senate Approves Stopgap Funding Bill Just After Shutdown Deadline
Trump had demanded. Carl Hulse Maya C. Miller and Catie Edmondson The Senate approved legislation to avert a federal government shutdown just after a midnight deadline, capping a chaotic week in ...
FiercePharma21d
A 'pivotal moment': Ionis enters next phase of commercial evolution with Tryngolza's FDA approval
With an FDA approval for Tryngolza (olezarsen) to treat the rare genetic disorder familial chylomicronemia syndrome (FCS), Ionis Pharmaceuticals enters a new era. While Ionis has gained several ...
precisionmedicineonline21d
FDA Approves Pfizer's Braftovi With Eli Lilly's Erbitux, Chemo in Colorectal Cancer
Although progression-free survival and overall survival data are not yet available from BREAKWATER, the FDA said that these outcomes will provide the post-marketing confirmatory evidence needed to ...
STAT22d
Ionis wins FDA approval for a rare disease therapy that lowers triglycerides
Ionis Pharmaceuticals on Thursday won Food and Drug Administration approval of a therapy for patients with a rare and deadly genetic disease that impedes the body’s ability to break down fats ...