Neurelis, Inc.
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Latest From Neurelis, Inc.
US FDA’s April Outlook: Decisions Pending For Rare Pediatric Diseases, New Antibiotics
User fee goal dates in April include four novel agents with breakthrough therapy designations, including Pfizer’s hemophilia B gene therapy and Immunity Bio’s IL-15 superagonist complex for bladder cancer.
How Sturdy Is PK/PD Bridge Between Epinephrine Injection Products And Nasal Spray?
FDA enumerates uncertainties in determining whether PK/PD results support a favorable risk-benefit assessment for use of ARS Pharmaceuticals’ epinephrine nasal spray for emergency treatment of allergic reactions, including anaphylaxis.
Nasal Naloxone On Brink Of OTC Among Additional Opioid Overdose Options On US FDA's Plate
Upcoming goal dates for Emergent’s Narcan and Harm Reduction Therapeutics’ RiVive will test the US FDA’s efforts to nurture the over-the-counter naloxone switch, followed by decisions on higher strength nasal opioid antagonist products from Opiant and Orexo to address fentanyl and other synthetic opioids.
More Options For Opioid Overdose: Nasal Naloxone On Brink Of OTC Use, While Opiant And Orexo Stay Rx To Counter High-Potency Opioids
Upcoming goal dates for Emergent’s Narcan and Harm Reduction Therapeutics’ RiVive will test the US FDA’s efforts to nurture the over-the-counter naloxone switch, followed by decisions on higher strength nasal opioid antagonist products from Opiant and Orexo to address fentanyl and other synthetic opioids.
Company Information
- Industry
- Biotechnology
-
Pharmaceuticals
- Specialty Pharmaceuticals
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Drug Delivery
- Macromolecule
- Nasal
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Biotechnology
- Large Molecule
- Other Names / Subsidiaries
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- Aegis Therapeutics
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