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 ...

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

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 ...

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

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

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

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 ...

Alembic Pharmaceuticals (Alembic) announced that it has received Final Approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Ivabradine Tablets, 5 mg ...

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 ...

must submit an NDS within 12 months of filing a New Drug Application (NDA) in the US. This requirement is established by ...