This expanded approval makes Sonu the first FDA-approved, drug-free solution for nasal congestion due to allergic and nonallergic rhinitis in children ages ≥12 years.

Dr Robert Ring, CEO of Kaerus Bioscience, said: "The FDA's granting of Orphan Drug Designation and Rare Pediatric Drug Designation for KER-0193 is an important step towards our objective of ...

London, UK, 14 May 2025 – Kaerus Bioscience (“Kaerus” or “the Company”), a clinical stage biopharmaceutical company created by Medicxi for the development of therapeutics for rare genetic syndromes of ...

The global gastrointestinal drugs market is expected to witness significant growth, driven by the rising prevalence of gastrointestinal diseases and the increasing demand for effective treatments.

Administration officials reversed a decision made during the Biden presidency that would have given millions of people access to weight-loss drugs paid for Medicare and Medicaid.

Legal and Regulatory Developments: Pediatric Pharmacology in the United States Federal drug regulatory efforts began in 1906; the role of the federal government has expanded several times since ...

High-grade glioma, a difficult-to-treat and aggressive form of pediatric and adult brain cancer, responded to avapritinib, a drug already approved by the US FDA. The corresponding study was published ...

MONTREAL — Neurenati Therapeutics Inc., a biotech company focused on rare pediatric diseases, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted both Orphan Drug ...

In patients with out-of-hospital cardiac arrest, the effectiveness of drugs such as epinephrine is highly time-dependent. An intraosseous route of drug administration may enable more rapid drug adm ...

The White House announced a new private sector pilot program to maintain uninterrupted access to seven pre-selected critical pediatric cancer drugs.

Papillon Therapeutics Receives Rare Pediatric Disease Designation from the U.S. Food and Drug Administration for PPL-002 for the Treatment of Danon Disease ...

The Pediatric Research Equity Act aims to close the gap in pediatric drug testing but faces significant delays in study completion. Rare disease designations exempt nearly half of new drugs from ...