The FDA has given its okay to Companion Medical’s InPen delivery system, which the company touts as the first U.S.-approved Bluetooth-enabled insulin pen.…

Several companies in the generic topical patch space have chimed in on a May draft guidance from the FDA that was meant to make data on those patches’ adhesion…

The FDA has given its okay to Espero Pharmaceutical’s Gonitro that is indicated to provide or prevent acute relief to patients who suffer an attack of angina…

The European Commission has approved GlaxoSmithKline’s Strimvelis, which uses a virus to deliver gene therapy for ADA-SCID, a rare genetic disorder that causes…

The FDA has approved Flamel Technologies’ Akovaz for the treatment of hypotension in the event of a crisis during a surgical procedure.

Janssen Pharmaceuticals, a unit of Johnson & Johnson, has submitted a new drug application to the FDA for a 500-milligram chewable tablet targeting…

The FDA has given the green light to pediatric use of Teva’s popular ProAir RespiClick Inhalation Powder to treat or prevent bronchospasm in children ages 4 to…

Shire is looking for FDA approval of a new chewable tablet of its popular ADHD drug Vyvanse that is targeted to children and adolescents.

Regulatory