Irish drugmaker Endo Pharmaceuticals has pulled away from its aim to label pain drug Opana ER as abuse-deterrent. This was a matter of concern for crush-proof…

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Several companies in the generic topical patch space have chimed in on a May draft guidance from the FDA that was meant to make data on those patches’ adhesion…

Sunovion’s COPD treatment passed muster in Phase III for both safety and efficacy, marking a success for its quick-acting nebulizer delivery system.

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 European Commission has granted eye care company pSivida an orphan medicinal product designation for its Medidur, which is used to treat chronic…

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…