Regulatory
-
According to ReCode Therapeutics, the FDA has cleared the 3rd part of an ongoing Phase 2 trial of nebulized RCT2100 CFTR mRNA therapy in cystic fibrosis patients, and enrollment has opened at US sites. The new… Read more . . .
-
According to Glenmark Pharmaceuticals, China’s National Medical Products Administration (NMPA) has approved Ryaltris olopatadine hydrochloride / mometasone furoate nasal spray for the treatment of allergic rhinitis. Grand Pharmaceuticals, which acquired the Chinese rights to Ryaltris… Read more . . .
-
Rein Therapeutics announced that the FDA has lifted a full clinical hold on the Phase 2 “RENEW” trial of the company’s LTI-03 inhaled dry powder caveolin-1-based peptide in patients with idiopathic pulmonary fibrosis (IPF). The… Read more . . .
-
Ritedose Corporation announced that it licensed an ANDA for tobramycin inhalation solution from Hikma and that the FDA has approved the company to manufacture and distribute the product. The company noted that tobramycin, which is… Read more . . .
-
According to Amneal Pharmaceuticals, the FDA has tentatively approved Amneal’s ANDA for a generic of Teva’s QVAR beclomethasone dipropionate HFA MDI, 40 μg/actuation and 80 μg/actuation, for the treatment of asthma. The company notes that… Read more . . .
-
Italian biotech Dompé announced that the US FDA has awarded a voucher under the new Commissioner’s National Priority Voucher (CNPV) pilot program for accelerated review of an application for the company’s intranasal cenegermin-bkbj (recombinant human… Read more . . .
-
According to Beckley Psytech and atai Life Sciences, the FDA has granted Breakthrough Therapy designation to Beckley’s BPL-003 intranasal mebufotenin (5-MeO-DMT) for the treatment of treatment-resistant depression. Earlier this year, the companies announced that a Phase… Read more . . .
-
The FDA has granted 510(k) clearance to Aptar Digital Health’s HeroTracker Sense MDI sensor, the company said. Aptar acquired the sensor’s developer, Cohero Health, in 2020 and launched the Bluetooth-enabled sensor in 2022. According to the… Read more . . .
-
According to Chiesi, the FDA has accepted the company’s NDA for its CHF5993 beclomethasone dipropionate /formoterol fumarate / glycopyrrolate MDI for the treatment of asthma. In April 2024, Chiesi announced that it was initiating a… Read more . . .
-
MannKind Corporation announced that the FDA has accepted the company’s sBLA for the use of Afrezza inhaled dry powder insulin in diabetes patients aged 4 to 17 and has set a PDUFA date of May 29, 2026.… Read more . . .
Upcoming Events
Sponsored by Intertek
Want information about upcoming OINDP-related events delivered directly to your inbox? click here
September 15-September 18: DDL New Researcher Network Summer Event, London, UK
September 16-September 17: IPAC-RS 2026 Nasal Innovation Forum, Jersey City, NJ, USA
September 24-September 25: Inhaled & Nasal Biologics | DNA Forum, Cambridge, UK
October 14-October 15: Advancing Bioequivalence Frameworks for Inhalation and Nasal Drug Products: Optimizing In Vitro, In Vivo, and In Silico Methods, Rockville, MD, USA
October 19-October 20: MVIC Autumn Training 2026, Lund, Sweden