Regulatory

AstraZeneca announced that the FDA has approved the company’s Breztri Aerosphere budesonide / glycopyrrolate / formoterol MDI for the treatment of asthma in patients aged 12 and older. The agency originally approved Breztri for the treatment of… Read more . . .

Cipla has received FDA approval of its ANDA for a generic version of Ventolin HFA albuterol MDI for the treatment of asthma, the company announced. GSK’s NDA Ventolin HFA was approved by the agency in… Read more . . .

 Vistagen announced that it has received a “study may proceed” letter from the FDA in response to the company’s IND for a Phase 2 trial of refisolone nasal spray for the treatment of hot flashes caused… Read more . . .

Savara has announced that the FDA is giving itself extra time to review the company’s BLA for molgramostim inhalation solution for the treatment of autoimmune pulmonary alveolar proteinosis, setting November 22, 2026 as the new… Read more . . .

ARS Pharmaceuticals and ALK announced that Canadian regulators have approved a 2 mg dose of neffy epinephrine nasal spray for the treatment of anaphylaxis in adults and children who weigh at least 30 kg. The… Read more . . .

 According to Savara, the MHRA has accepted the company’s marketing application for Molbreevi molgramostim inhalation solution for the treatment of autoimmune pulmonary alveolar proteinosis for accelerated review, with a decision expected by the end of… Read more . . .

ARS Pharmaceuticals announced that the FDA has approved an sNDA to remove the age requirement for the 1 mg dose of neffy epinephrine nasal spray for the treatment of anaphylaxis. A 2 mg dose of… Read more . . .

Nuance Pharma announced that the Hong Kong Drug Office has approved Ohtuvayre ensifentrine inhalation suspension for the treatment of COPD. According to Nuance, Ohtuvarye had been available through certain medical facilities in Macau and Hong Kong… Read more . . .

According to Glenmark, the FDA has approved the company’s ANDA for a generic equivalent of GSK’s FloVent HFA fluticasone propionate MDI with competitive generic therapy (GGT) designation. FloVent HFA was initially approved in 2004, and… Read more . . .