Regulatory

According to ARS Pharmaceuticals, both the US Patent and Trademark Office and the European Patent Office have upheld the validity of claims in patents related to neffy epinephrine nasal spray / EURneffy adrenaline nasal spray.… Read more . . .

Polyrizon announced that it has submitted a pre-submission package to the FDA for its PL-14 Allergy Blocker nasal spray. The company describes the product as “a novel, non-invasive nasal spray that forms a physical barrier… Read more . . .

According to ARS Pharmaceuticals, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has approved 1mg and 2mg doses of neffy epinephrine nasal spray for the treatment of anaphylaxis in people who weigh more than 15 kilograms.… Read more . . .

AstraZeneca announced that the FDA has approved the company’s supplemental NDA to add data related to the treatment of mild asthma to the label for Airsupra albuterol / budesonide MDI. In October 2024, AstraZeneca and… Read more . . .

According to Pulmovant, the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted orphan drug designation to Pulmovant’s inhaled dry powder mosliciguat for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD).… Read more . . .

According to BiomX, the FDA has placed a clinical hold on the company’s recently-initiated Phase 2b trial of BX004 inhaled phage cocktail in cystic fibrosis patients with chronic P. aeruginosa lung infections. BiomX said that the… Read more . . .

Proveca and Cessatech have announced the submission of a pediatric-use marketing authorization (PUMA) application for CT001 sufentanil / ketamine nasal spray for the treatment of pain in pediatric patients and said that the EMA has… Read more . . .