Regulatory

Evoke Pharma said that it has received minutes from a July 25, 2019 Type A meeting with the FDA and that the company now plans to resubmit its NDA for Gimoti metoclopramide nasal spray for… Read more . . .

According to Acorda Therapeutics, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion regarding Inbrija inhaled dry powder levodopa for the treatment of motor fluctuations (OFF periods)… Read more . . .

The FDA has announced that it approved Eli Lilly and Company’s Baqsimi single-use intranasal dry powder glucagon for the emergency treatment of severe hypoglycemia. Lilly announced that it had submitted the NDA for Baqsimi in… Read more . . .

The FDA has issued a final guidance titled “Postmarketing Safety Reporting for Combination Products Guidance for Industry and FDA Staff” that specifies how to comply with postmarketing safety reporting (PMSR) requirements for combination products issued in 2016.… Read more . . .

Penthrox methoxyflurane inhaler maker Medical Developments International said that it recently met with the FDA regarding the agency’s August 2018 clinical hold letter on Penthrox, and the company now has a path forward to resolve… Read more . . .

Aridis Pharmaceuticals said that the EMA has granted orphan drug designation to the company’s AR-501 inhaled gallium citrate for the treatment of pulmonary infections in cystic fibrosis patients. The company said that the FDA had… Read more . . .

The FDA has approved low, medium, and high dose versions of Teva’s AirDuo Digihaler fluticasone propionate/salmeterol digital DPI for the treatment of asthma, the company said. The inhaler should be available in the US sometime next… Read more . . .

Insys Therapeutics, which recently filed for bankruptcy, said that the FDA has accepted its NDA for the company’s single unit dose naloxone nasal spray. In December 2018, Insys said that it planned to submit NDAs… Read more . . .