Amryt Pharma said on February 28 the U.S. Food and Drug Administration declined to approve the company’s drug for the treatment of a group of rare skin diseases called epidermolysis bullosa.
U.S. Food and Drug Administration PDUFA dates on the calendar for July include an NDA review for Jazz Pharmaceuticals’ experimental medicine for cataplexy.
The U.S. Food and Drug Administration approved Evofem Biosciences Inc.’s Phexxi (lactic acid, citric acid and potassium bitartrate) vaginal gel for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception.
Mallinckrodt Plc received a subpoena from the U.S. Securities and Exchange Commission for documents related to the drugmaker’s lawsuit against the U.S. Department of Health and Human Services (HHS).
The Australian subsidiaries of British drugmaker GlaxoSmithKline and Swiss drugmaker Novartis misled customers and broke the law by promoting identical liniments as though they could treat specific ills, an Australian court found.
The U.S. FDA approved Bausch + Lomb’s Lotemax SM (loteprednol etabonate ophthalmic gel) 0.38%, a new gel formulation for treating postoperative inflammation and pain following ocular surgery.
Austin, Texas-based Pain Therapeutics Inc. announced feedback from a meeting held Jan. 31, 2019, with the U.S. Food and Drug Administration regarding the drug candidate Remoxy ER, an abuse-deterrent extended-release gel formulation of oxycodone.
Evofem Biosciences shares rose 38 percent after the company’s birth control gel showed effectiveness in a late-stage study, bringing the first hormone-free contraceptive close to approval.