• Glenmark’s generic equivalent of FloVent HFA fluticasone propionate MDI gets final approval from FDA

  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 . . .]

• Rein Therapeutics restarts Phase 2 trial of LTI-03 inhaled dry powder synthetic peptide in patients with IPF

  Rein Therapeutics announced the that the first patient has been dosed in a Phase 2 study evaluating its LTI-03 caveolin-1 scaffolding domain peptide DPI in patients with idiopathic pulmonary fibrosis, with interim data expected later… [Read more . . .]

• AtaiBeckley announces plans for Phase 3 development of BPL-003 intranasal mebufotenin

  AtaiBeckley said that it completed an End‑of‑Phase 2 meeting with the FDA regarding BPL‑003 intranasal mebufotenin for the treatment of treatment‑resistant depression (TRD) and that the agency indicated that it supports the company’s plan for… [Read more . . .]

• Esperion to acquire Corstasis Therapeutics and its Enbumyst bumetanide nasal spray

  US biopharm Esperion will pay $75 million in cash up front and up to $180 million in milestone payments to acquire Corstasis Therapeutics and its Enbumyst bumetanide nasal spray, the companies said. The deal also… [Read more . . .]

• Cullgen calls off merger with Pulmatrix

   According to Pulmatrix, Cullgen has terminated the 2024 merger agreement between the companies. Pulmatrix said that it would In December 2025, Pulmatrix and Cullgen announced that Chinese authorities had still not approved the merger, and… [Read more . . .]

• SpliSense’s SPL84 inhaled antisense oligonucleotide for CF gets early PRIME designation from the EMA

• NOFLU consortium gets HaDEA funding for development of an intranasal vaccine based on Ethris technology

• SoftOx gets approval for SIS-02 Phase 1 trial of SIS hypochlorous acid inhalation solution

• Phase 3 PROSERA trial of Gossamer Bio’s seralutinib DPI in patients with PAH misses its primary endpoint

• Iconovo signs letter of intent with Lonza for spray dried formulation of additional inhaled biologics

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