The U.S. Food and Drug Administration approved Ascendis Pharma’s Skytrofa (lonapegsomatropin-tcgd) for children 1 year and older who have growth failure from inadequate secretion of endogenous growth hormone (GH).
The U.S. Food and Drug Administration approved Novartis’ Kesimpta (ofatumumab, formerly OMB157) as an injection for subcutaneous use for the treatment of relapsing forms of multiple sclerosis in adults.
A look at upcoming PDUFA dates for the U.S. Food and Drug Administration, including Viela Bio’s inebilizumab for NMOSD.
Merck KGaA agreed to sell the German drugmaker’s allergy business Allergopharma to Dermapharm SE for an undisclosed price, but will continue to develop an autoinjector to treat allergic shock.
The U.S. Food and Drug Administration approved self-administration of AstraZeneca’s asthma treatment Fasenra which uses a pre-filled, single-use auto-injector pen.
Mylan NV agreed to settle U.S. SEC charges that the company hid from investors the impact of a federal probe into the drugmaker’s overbilling the government for the EpiPen allergy treatment.
The U.S. drug regulator approved Palatin Technologies and Amag Pharmaceuticals’ drug to restore sexual desire in premenopausal women.
EpiPens and other autoinjectors filled with epinephrine to treat severe allergic reactions may still be potent enough to work many months past their labeled expiration date, according to a study that concludes patients might need expensive refills less often.
Shares of Zealand Pharma A/S were up more than 2 percent after the company announced that dasiglucagon, a potential treatment for severe hypoglycemia, hit the mark in a Phase III study.
Pfizer Inc. received a request for documents as part of a U.S. investigation related to quality issues involving the manufacture of auto-injectors at the company’s Meridian Medical Technologies site.