Sunvozertinib has shown promising results in patients with non–small cell lung cancer with an EGFR exon 20 insertion mutation ...

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

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 ...

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 ...

The authorised ANDA is a therapeutic equivalent of the reference-listed drug (RLD), Corlanor tablets, in the same 5 mg and ...

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

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

Dizal has submitted sunvozertinib’s new drug application (NDA) to the US Food and Drug Administration (FDA) aiming to secure ...

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

Syndax Pharmaceuticals advances Revumenib for relapsed AML with FDA decision pending. See why SNDX stock is a key player in ...

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

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 ...