Based on results from its study for switch NDA, with primary endpoint of users’ success in administering naloxone nasal spray, Emergent changes which DFl panels include the directions. FDA will tell advisory committee the firm has no study data validating effectiveness of changes.
Emergent BioSolutions, Inc. will ask a US Food and Drug Administration advisory panel to agree that rearranging the placement of directions within labeling it tested for OTC use of its naloxone nasal spray will eliminate user errors which concern agency officials.
FDA officials, however, will explain at a joint meeting of the Nonprescription Drug and Anesthetic and Analgesic Drug Products advisory...
Now available without a prescription, Dymista Control is the first OTC combination treatment for consumers who are struggling to control their seasonal allergic rhinitis with a corticosteroid or antihistamine nasal spray, according to the firm.
Creating a working group to drive Rx-to-OTC switch is one of the ways in which Finland could expand self-care and save €60m per year for the country's health system, suggests a recently published report commissioned by Haleon.
Reacting to chancellor Rachel Reeves' 2025 public spending review, PAGB welcomed increased funding for healthcare and life sciences while stressing the need to promote self-care practices.
The EU Council has introduced a key amendment to Article 51 (para 1, point e) of the new pharma directive: “A medicinal product shall be subject to medical prescription where it is an antimicrobial, unless intended for topical use.”
Latest European appointments: Opella names Germany director; Stada has new Western Europe head; Futura makes CEO change.
Health Subcommittee will discuss reauthorizing OMUFA during a hearing on how to “maintain and improve” the public health workforce and rural health as well as access to OTC medicines.
Thibaut Mongon is out as Kenvue CEO, a post he’s held since J&J spun it out in July 2023, after the firm’s results came under increased investor scrutiny over the past year. The board appointed as interim CEO Kirk Perry, a board member since December who most recently headed technology, data and pre
