Regulatory
-
The FDA has approved an Aurobindo ANDA for generic albuterol (salbutamol) sulfate inhalation solution and, while the agency did not issue a press release, the news was included in the FDA’s COVID-19 “Daily Roundup” and… Read more . . .
-
According to Beyond Air, the company has received permission from the FDA to initiate a clinical study of its LungFit inhaled nitric oxide system for the treatment of COVID-19 patients. The announcement comes almost a month… Read more . . .
-
German medical device company B. Braun Medical announced that the FDA has issued Emergency Use Authorization (EUA) of several of the company’s infusion pumps for “tracheal delivery of continuous nebulized medications into a nebulizer to… Read more . . .
-
The FDA has announced its approval of a Cipla albuterol sulfate MDI, a generic of 3M’s Proventil HFA for the treatment of asthma. The FDA announcement noted that the agency recently issued a revised draft… Read more . . .
-
Liquidia Technologies said that the FDA accepted the company’s 505(b)(2) NDA for its LIQ861 treprostinil DPI for the treatment of pulmonary arterial hypertension (PAH), with a PDUFA goal date of November 24, 2020. The company announced in… Read more . . .
-
A meeting of the FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) that had been scheduled for April 21, 2020 has been postponed due to the COVID-19 pandemic. No new meeting date was announced. The committee was… Read more . . .
-
At a March 27, 2020 meeting of the EMA’s Committee for Medicinal Products for Human Use (CHMP), the committee adopted a positive opinion regarding the MAAs for Novartis’s Atectura Breezhaler indacaterol/mometasone furoate and a duplicate… Read more . . .
-
Vero Biotech has announced that the FDA will allow expanded access to the company’s Genosyl DS tankless inhaled nitric oxide (iNO) delivery system so that it can be used for the treatment of cardiopulmonary symptoms of… Read more . . .
-
The PAP Foundation, a US organization that advocates for pulmonary alveolar proteinosis (PAP) patients, says that it supports FDA approval of Savara’s Molgradex inhaled recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF). The group said that it… Read more . . .
-
Nephron Pharmaceuticals CEO Lou Kennedy spoke to local reporters in the company’s home state of South Carolina on March 17, 2020, describing the company’s efforts to increase production of its inhalation solutions and suspensions to… Read more . . .
Upcoming Events
Sponsored by Intertek
Want information about upcoming OINDP-related events delivered directly to your inbox? click here
October 21-October 22: MVIC Symposium, Lund, Sweden
November 10-November 11: Rescon Europe 2026, Porto, Portugal
December 9-December 11: DDL 2026, Edinburgh, Scotland