Medications

FDA Approves Gemtesa

FDA Approves Gemtesa (vibegron) Tablets for the Treatment of Patients with Overactive Bladder (OAB) IRVINE, Calif. & BASEL, Switzerland–(BUSINESS WIRE)–Dec. 23, 2020– Urovant Sciences (Nasdaq: UROV) announced today that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for once-daily 75 mg Gemtesa (vibegron), a beta-3 adrenergic receptor (β3) agonist, […]

Medications

FDA Approves Genentech’s Ocrevus (ocrelizumab) Shorter 2-Hour Infusion for Relapsing and Primary Progressive Multiple Sclerosis

South San Francisco, CA — December 14, 2020 — Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved a shorter two-hour infusion time for Ocrevus® (ocrelizumab), dosed twice-yearly for those living with relapsing or primary progressive multiple sclerosis (MS) who have […]

Health News

Canada approves Pfizer’s coronavirus vaccine

Pfizer’s COVID-19 vaccine gets positive FDA review We will have tens of millions of American vaccinated by the end of 2020 Fox News medical contributor Dr. Nicole Saphier tells ‘Fox & Friends. Canadian health officials on Wednesday granted approval to Pfizer and BioNTech’s two-dose coronavirus vaccine, becoming the second Western country to do so in recent days.  […]

Medications

FDA Approves Jatenzo

March 27, 2019 — The U.S. Food and Drug Administration today approved Jatenzo (testosterone undecanoate), an oral testosterone capsule to treat men with certain forms of hypogonadism. These men have low testosterone levels due to specific medical conditions, such as genetic disorders like Klinefelter syndrome or tumors that have damaged the pituitary gland. Jatenzo should […]

Medications

FDA Approves Ultomiris

BOSTON–(BUSINESS WIRE)– December 21, 2018 — Alexion Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Ultomiris (ravulizumab-cwvz), the first and only long-acting C5 complement inhibitor administered every eight weeks, for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH), a debilitating ultra-rare blood disorder characterized by complement-mediated destruction […]

Health News

FDA approves return of popular Primatene Mist asthma inhaler

A new version of the once-popular asthma inhaler Primatene Mist will soon return to U.S. stores. The Food and Drug Administration approved the over-the-counter aerosol inhaler late Wednesday. It’s for temporary relief of mild, intermittent asthma symptoms in people ages 12 and up. The original Primatene Mist was pulled from store shelves seven years ago […]