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 ...

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

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

Novavax is already poised to benefit from a separate combined Covid-flu vaccine via a deal with Sanofi announed earlier this year. Under the $1.4 billion co-licensing agreement, announced in May, ...

Dizal has submitted sunvozertinib’s new drug application (NDA) to the US Food and Drug Administration (FDA) aiming to secure approval for treating locally advanced or metastatic non-small cell lung ...

The FDA is set to decide on four promising therapies in the next two weeks, including a CAR T for acute lymphoblastic ...

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

The Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for tapinarof cream, 1% in the treatment of atopic dermatitis in adults and ...

Based on the totality of clinical evidence from the Phase 3 OASIS-HAE and OASISplus studies, as well as new three ... The FDA previously granted donidalorsen Orphan Drug Designation in 2023.

Independent advisers to the U.S. Food and Drug Administration on Thursday voted against recommending Lexicon Pharmaceuticals' ...