Regulatory

According to Silverback Therapeutics and ARS Pharmaceuticals, the FDA has accepted ARS's NDA for its Neffy intranasal epinephrine for the treatment of allergic reactions, including anaphylaxis, with a PDUFA date set for mid-2023. The two companies recently announced that they would merge, with the resulting company operating as ARS Pharmaceuticals and focused on … [Read more...] about FDA accepts NDA for ARS Pharmaceuticals’ Neffy epinephrine nasal spray for the treatment of allergic reactions, including anaphylaxis

Australian cannabinoid developer Incannex Healthcare said that its pre-IND meeting with the FDA regarding its IHL-216A inhaled CBD/isoflurane for the treatment of traumatic brain injury was "constructive." In June 2021, Incannex signed an agreement with inhalation CDMO Vectura for preclinical development services for IHL-216A. The company said at that time that … [Read more...] about Incannex announces completion of pre-IND meeting with FDA regarding IHL-216A inhaled CBD/isoflurane

Harm Reduction Therapeutics announced that it has made an initial filing for a rolling review of its NDA for RiVive naloxone nasal spray, an OTC product for the treatment of opioid overdose. In August 2022, the company announced that it had received Fast Track designation for RiVive (HRT001) and had signed a commercial supply agreement. The company said that it is … [Read more...] about Harm Reduction Therapeutics initiates rolling NDA submission for RiVive intranasal naloxone

According to Bausch Health and Glenmark, Health Canada has approved Ryaltris olopatadine / mometasone furoate nasal spray for the treatment of seasonal allergic rhinitis in people aged 6 and older. Bausch Health acquired the Canadian rights to Ryaltris in March 2021. Ryaltris has been approved in Australia since December 2019, in Europe since April 2021 and in the US … [Read more...] about Health Canada approves Ryaltris nasal spray for the treatment of seasonal allergic rhinitis

According to CanSino Biologics, China's National Medical Products Administration (NMPA) has approved the company's Convidecia Air nebulized COVID-19 vaccine as a booster dose. In December 2021, CanSino Bio announced a deal with Aerogen for the use of Aerogen vibrating mesh nebulizers for delivery of the adenovirus vector vaccine. … [Read more...] about China okays emergency use of CanSinoBio’s Convidecia Air inhaled COVID-19 vaccine

According to Bharat Biotech, Indian regulators have cleared its iNCOVACC (BBV154) intranasal vaccine against COVID-19 for use in adults aged 18 and older under a Restricted Use in Emergency Situation. Following the approval, Bharat Bio said, "the product will be launched and available for use in due course of time." Bharat Bio announced in September 2020 that it … [Read more...] about India clears Bharat Biotech’s iNCOVACC intranasal COVID-19 vaccine for emergency use

The FDA has published notice of an online meeting of the Pulmonary-Allergy Drugs Advisory Committee (PADAC) to take place on November 8, 2022 for the purpose of discussing Avillion and AstraZeneca's NDA (214070) for PT027 albuterol / budesonide MDI for the treatment of asthma in patients aged 4 and older. The agency accepted the NDA in May 2022. According to the … [Read more...] about PADAC schedules meeting to discuss Avillion’s NDA for PT027 albuterol / budesonide MDI