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In the complete response letter (CRL) it issued to the company, the FDA said that it cannot approve the New Drug Application (NDA) of iclaprim in its present

Egaten is claimed to be the only FDA-approved drug to treat fascioliasis, which is a neglected tropical disease. Fascioliasis, which is commonly known as liver fluke infestation, is

Selonsertib has failed to meet the pre-specified week 48 primary endpoint of a ≥ 1-stage histologic improvement in fibrosis without worsening of NASH. Stellar-4 is a phase 3

The 24 May is the new Prescription Drug User Fee Act (PDUFA) target action date for Jakafi, which is the treatment for patients with GVHD who have had

The M7824 is an investigational bifunctional fusion protein immunotherapy, which is currently under clinical development, including potential registration studies, for multiple difficult-to-treat cancers. Bintrafusp alfa is said to

The approval being sought from the US Food and Drug Administration (FDA) is for the post-surgery use of Kadcyla in patients with HER2-positive early breast cancer with residual

The CHMP’s positive opinion for the marketing authorization of Forxiga is for use as an oral adjunct treatment to insulin in adults with T1D. Forxiga, which is a

The two trials, dubbed CREAD 1 and CREAD 2, will be discontinued as a pre-planned interim analysis indicated that crenezumab was not likely to meet their primary endpoint,

Imbruvica in combination with obinutuzumab is said to be the first approved non-chemotherapy combination regimen for treatment-naïve patients with CLL/SLL, which is the most common form of leukemia