Submitted New Drug Application (NDA) to FDA for TNX-102 SL for fibromyalgia based on two statistically significant Phase 3 studiesGranted Fast ...

for the ketamine Abbreviated New Drug Application, which was assigned a Generic Drug User Fee Amendments of 2022 ("GDUFA”) goal date of October 29, 2024. On November 12, 2024, the FDA granted the ...

AstraZeneca’s earnings were boosted by its oncology, cardiovascular, respiratory and immunology (R&I), and rare disease ...

While A.I. promises breakthroughs, industry leaders warn that transparency and patient safety must remain front and center.

Aerobic exercise has been linked with Parkinson's disease progression and risk. ( Washington Post) Air purifiers in residential aged-care facilities did not reduce the incidence of acute respiratory ...

The FDA informed Intercept that it is unable to approve the sNDA in its current form, consistent with the outcome of the Gastrointestinal Drugs Advisory Committee (GIDAC) meeting in September 2024. In ...

The US FDA has cleared an investigational new drug (IND) application for HG202, by HuidaGene Therapeutics. This drug is the ...

This drug is the world’s first-ever CRISPR/Cas13 RNA-editing therapy for clinical use in treating neovascular age-related macular degeneration (nAMD). The US FDA has cleared an investigational new ...

Harmony Biosciences surpassed $2 billion in cumulative net product revenue less than 5 years on the market, highlighting ...

The US regulatory agency has pushed the PDUFA date by three months to 18 March 2025 to “allow for more time to review ...

Following the clearance of an investigational new drug application from the FDA, a phase 1 trial will examine the novel ...

FDA sets PDUFA Action Date of June 28, 2025 ...