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Elanco's Credelio™ CAT (lotilaner) Receives First FDA Emergency Use Authorization (EUA) for Treatment of New World Screwworm (NWS) in Cats
Prnewswire· 2025-11-21 18:35
Accessibility StatementSkip Navigation EUA to Treat Cats for NWS Issued Prior to Fly Being Detected in the U.S.; Action Prepares Veterinarians and Pet Owners with Treatment Options INDIANAPOLIS, Nov. 21, 2025 /PRNewswire/ --Â Elanco Animal Health Incorporated (NYSE: ELAN) today announced it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for Credelioâ"¢ CAT (lotilaner) to treat New World screwworm (NWS) infestations in cats. This authorization represents the f ...
Elanco's Credelio™ (lotilaner) Receives First Ever FDA Emergency Use Authorization (EUA) against New World Screwworm (NWS) in Dogs
Prnewswire· 2025-10-24 20:55
Core Insights - Elanco Animal Health has received Emergency Use Authorization (EUA) from the FDA for Credelio (lotilaner) to treat New World screwworm (NWS) infestations in dogs, marking the first EUA granted for this purpose in dogs [1][10] - The authorization is a proactive measure in response to confirmed NWS cases detected near the U.S.-Mexico border, allowing veterinarians and pet owners to have a treatment option ready [1][10] Summary by Sections Emergency Use Authorization - The EUA for Credelio is based on a study showing 100% efficacy against NWS larvae within 24 hours of treatment in naturally infested dogs [2] - The study was conducted on a limited population of eleven dogs in Brazil, raising questions about its applicability to the U.S. population [3] Treatment and Prevention - Effective parasite protection is crucial, as NWS infestations begin when female flies lay eggs on open wounds, with one female capable of laying 200-300 eggs at a time [4] - The U.S. Animal Plant Health and Inspection Service (APHIS) recommends protecting pets from wound-causing parasites to prevent NWS infestations [5] Veterinary Insights - Veterinarians emphasize the importance of preventing or rapidly treating wounds to protect pets from NWS, suggesting year-round flea and tick protection as a preventive measure [6] Company Background - Elanco Animal Health is a global leader in animal health, dedicated to innovating products and services for disease prevention and treatment in animals, with a commitment to improving animal health and community impact [9]
X @Mike Benz
Mike Benz· 2025-08-27 20:37
Regulatory Actions & Approvals - FDA rescinded emergency use authorizations for Covid vaccines, which were previously used to justify broad mandates [1] - FDA issued marketing authorization for Moderna (6+ months), Pfizer (5+), and Novavax (12+) vaccines for those at higher risk [2] - Vaccines remain available for all patients who choose them after consulting with their doctors [2] Policy Changes - The actions fulfill promises to end Covid vaccine mandates [1][3] - The actions fulfill promises to keep vaccines available to people who want them, especially the vulnerable [3] - The actions fulfill promises to demand placebo-controlled trials from companies [3]
Revive Therapeutics Announces Closing of First Tranche of Private Placement and Debt Settlement
Globenewswire· 2025-08-11 23:28
Core Viewpoint - Revive Therapeutics Ltd. has successfully closed the first tranche of its private placement offering, raising a total of $60,900 through the issuance of 2,900,000 units at a price of $0.021 per unit, while also settling a note payable through the issuance of additional units [1][2][3]. Group 1: Offering Details - The first tranche of the offering consisted of 2,900,000 units, generating gross proceeds of $60,900 for the company [1]. - Each unit comprises one common share and one common share purchase warrant, with the warrant allowing the holder to acquire one common share at an exercise price of $0.05 for 36 months [2]. - The company issued an additional 3,209,523 units to settle a note payable of $67,400, maintaining the same issue price of $0.021 per unit [1][3]. Group 2: Use of Proceeds - The gross proceeds from the offering will be allocated for working capital and the payment of certain trade payables [2]. Group 3: Compensation Options - In connection with the offering, the company issued 100,000 compensation options to an investment dealer, allowing the dealer to purchase units at a price of $0.05 for 18 months [4]. - Each compensation unit consists of one common share and one-half of a common share purchase warrant, with the whole warrant allowing acquisition of one compensation share at an exercise price of $0.05 for 36 months [5]. Group 4: Company Overview - Revive Therapeutics is focused on developing innovative therapeutics for critical medical needs, leveraging FDA regulatory incentives for rapid advancement and market entry [6]. - The company is currently concentrating on the potential of Bucillamine for infectious diseases and medical countermeasures, as well as advancing its Psilocybin and molecular hydrogen therapeutic programs [6].