Semaglutide, the main ingredient in Ozempic and Wegovy, is in ongoing shortage, the FDA says, and compounded versions of these drugs are still permitted. The U.S. Food and Drug Administration (FDA ...
The FDA approved Zepbound (tirzepatide) as the first prescription medication specifically for adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity. People taking Zepbound lost ...
Advancing TP-04 (lotilaner ophthalmic gel) for the potential treatment of Ocular Rosacea, another large, underserved eye disease with no FDA-approved therapy; Initiation of Phase 2 study planned for ...
The NDA submission was completed by Sentynl who will be responsible for commercialization upon approval. As described below ... continues to advance with two recent FDA approvals received in Q4 of ...
The Food and Drug Administration (FDA) gave the green light to the the first-ever medication for obstructive sleep apnea (OSA). The newly approved drug, Zepbound (tirzepatide), targets adults with ...
Also Read: Big Biopharma Trails Behind The Market: JP Morgan’s 2025 Outlook on Eli Lilly, Merck, and More In March 2024, the FDA approved Winrevair (sotatercept-csrk), for injection, 45mg ...
Almost exactly 10 years after the FDA’s initial FDA approval for Bristol Myers Squibb’s Opdivo as the first PD-1 inhibitor in the U.S., the agency has cleared an under-the-skin version of the ...
Subcutaneous nivolumab and hyaluronidase-nvhy is FDA-approved for adult solid tumors, offering a new administration route for PD-1 inhibitors. The phase 3 CheckMate-67T trial confirmed ...
Opdivo was previously only available as a solution for intravenous (IV) infusion. The approval of Opdivo Qvantig was supported by data from the randomized, open-label phase 3 CheckMate-67T study ...
The FDA’s Center for Drug Evaluation and Research (CDER) approved 50 new small molecules, biologics and oligonucleotide therapeutics last year. The class of 2024 was a little smaller than that ...
On December 25th Xinhua, the state-run news agency, reported that China had approved plans to build the world’s largest hydroelectric dam on the lower reaches of the Yarlung Tsangpo, which flows ...