Regulatory

Teva has announced the FDA’s acceptance of its supplemental NDA for a low-dose formulation of QNASL beclomethasone dipropionate HFA nasal spray for the treatment of allergic rhinitis in children aged 4-11. The FDA approved QNASL… Read more . . .

GlaxoSmithKline and Theravance have announced that they have received marketing authorization for the Anoro Ellipta umeclidinium/vilanterol DPI for the treatment of COPD in Europe. The EMA’s Committee for Medicinal Products for Human Use (CHMP) issues… Read more . . .

Propeller Health (formerly known as Asthmapolis) has announced that the latest version of its inhaler tracking system has received 510(k) clearance from the FDA. The system includes a sensor that snaps onto an MDI and… Read more . . .

The FDA has issued a Complete Response Letter (CRL) for Acorda Therapeutics’ Plumiaz diazepam nasal spray for the treatment of cluster seizures in epilepsy patients, the company has announced. Acorda submitted a 505(b)(2) application for… Read more . . .

Less than a week after the approval of GSK’s Incruse Ellipta umeclidinium DPI in Europe, the company has announced that the FDA has approved the product for the treatment of COPD and it expects to… Read more . . .

GSK has announced that the European Commission has granted marketing authorization for its Incruse Ellipta umeclidinium DPI for the treatment of COPD with a dosage of 55 mcg. According to the company’s announcement, launches in… Read more . . .

The European Commission has approved Teva’s DuoResp Spiromax budesonide/formoterol DPI for the treatment of asthma and COPD, the company has announced. The EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion… Read more . . .

The US FDA has proposed a new rule that would require e-cigarette makers to register with the agency, disclose ingredients used in their inhalation solutions, and provide scientific evidence to support claims of reduced risk… Read more . . .