and plans to submit a supplemental New Drug Application (sNDA) seeking traditional approval of FILSPARI for focal segmental glomerulosclerosis (FSGS). The sNDA will be based on existing data from ...

Sucampo Pharmaceuticals Inc. has been granted FDA approval of a supplemental new drug application (sNDA) for unoprostone isopropyl for the lowering of intraocular pressure in patients with open ...

ELYXYB, currently approved for use in adults for the ... It is important to note that the FDA’s acceptance of the SNDA is just one step in the process, and the outcome of the review is not ...

Merck MRK announced that the FDA has accepted its supplemental new drug application (sNDA) seeking approval of its oral HIF-2α inhibitor, Welireg (belzutifan), for a new indication. The sNDA is ...

Teva Pharmaceuticals (TEVA) and Medincell (MEDCL) announced that the supplemental New Drug Application sNDA for UZEDY extended-release ...

The biopharmaceutical firm revealed plans to submit a supplemental New Drug Application (sNDA) for FILSPARI ... steps in the FDA review process. The potential approval of FILSPARI for FSGS ...

At Sonida Senior Living, a filing with the SEC revealed that on Friday, Michael Simanovsky bought 42,111 shares of SNDA, at a cost of $21.32 each, for a total investment of $897,835. So far ...

Parsippany, New Jersey Thursday, February 27, 2025, 13:00 Hrs [IST] ...

Company completed Type C meeting with FDA, aligning on its plan to submit an sNDA; submission expected around end of 1Q25 If approved ... the upcoming review process.” The Type C meeting ...

Detailed price information for Travere Therapeutics Inc (TVTX-Q) from The Globe and Mail including charting and trades.