This approval adds to Granules India's existing 67 ANDA approvals from the US FDA, strengthening its position in regulated ...

An FDA AdCom in September recommended against full approval for Ocaliva by a 13-1 vote for the treatment of primary biliary ...

The expanded approval intensifies the rivalry with Jazz Pharmaceuticals, which has previously attempted to block Lumryz’s ...

The FDA was expected to decide on the application of sotorasib and panitumumab for the treatment of metastatic colorectal ...

Innovative application of an existing drug offers promising alternative treatment to traditional chemotherapy for patients with appendix cancer.

Astellas Pharma Ltd. today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted authorization for PADCEV™ (enfortumab vedotin, an antibody-drug conjugate [ADC]) in ...

Lo, PhD, has been appointed the new Editor-in-Chief of the journal ASSAY and Drug Development Technologies. Dr. Lo is ...

After two previous failed attempts with the FDA, AbbVie now has one more offering in its lineup — a critical step as it ...

Lumryz is the only FDA-approved once-at-bedtime oxybate treatment for cataplexy or excessive daytime sleepiness in children ...

The FDA has accepted a new drug application for the intravesical solution of UGN-102 in low-grade intermediate-risk ...

The FDA recently declined to approve MDMA-assisted therapy for PTSD, but experts said there are many other treatments on the ...

Alnylam Pharmaceuticals ALNY announced that it has submitted a Type II Variation to the European Medicines Agency for ...