• Nasus Pharma names Brendan O’Grady as its new CEO

  Intranasal drug developer Nasus Pharma announced that it has hired former Teva USA President and CEO Brendan O’Grady as its new CEO. O’Grady was most recently CEO of Assertio Holdings and was previously CEO of… [Read more . . .]

• Chiesi returns the rights to seralutinib DPI for pulmonary hypertension to Gossamer

  Gossamer Bio announced that it has reacquired the ex-US rights to its seralutinib dry powder inhaler for the treatment of pulmonary hypertension from Chiesi, which acquired the rights to the seralutinib DPI in 2024. According to… [Read more . . .]

• Revagenix initiates Phase 1 trial of Rev-56 inhaled antibiotic for NCFB

  US-based biopharm Revagenix announced that it has initiated a Phase 1 trial of Rev-56, which it describes as an “inhaled, anti-pseudomonal therapy for non-cystic fibrosis bronchiectasis (NCFB).” The first part of the study will evaluate… [Read more . . .]

• FDA approves Cipla’s ANDA for a generic of Advair Diskus fluticasone / salmeterol DPI

  According to Cipla, the FDA has approved the company’s ANDA for 100/50 mcg, 250/50 mcg, and 500/50 mcg strengths of its generic version of Advair Diskus fluticasone propionate / salmeterol DPI for the treatment of… [Read more . . .]

• CHMP adopts negative opinion regarding Cessatech and Proveca’s KemSu (CT001) sufentanil / ketamine nasal spray for pediatric patients

  According to Cessatech, the EMA’s Committee for Medicinal Products for Human Use has adopted a negative opinion regarding Proveca’s  pediatric-use marketing authorization (PUMA) of KemSu (CT001) sufentanil / ketamine nasal spray for the treatment of… [Read more . . .]

• Nanopharm facility in Wales gets GMP certification

• HFO 1234ze formulation of AstraZeneca’s Breztri Aerosphere budesonide / glycopyrronium / formoterol MDI approved in Australia

• MHRA approves HFA 152a formulation of Chiesi’s Clenil Modulite beclametasone MDI

• FDA approves pediatric use of Glenmark’s Ryaltris olopatadine / mometasone nasal spray for seasonal allergic rhinitis

• Eli Lilly to acquire AtaiBeckley and its BPL-003 intranasal mebufotenin

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