News

OTO-311 is a sustained-exposure formulation of potent and selective N-Methyl-D-Aspartate (NMDA) receptor antagonist gacyclidine. The approval has been granted to commence a Phase I dose escalation clinical safety

Quinsair is an inhaled formulation of levofloxacin, which already received approval in the European Union and Canada. It is used to manage chronic pulmonary infections due to Pseudomonas

SEC alleged that the company’s JV violated the Foreign Corrupt Practices Act (FCPA) and reaped over $11m in profits from this violation. According to the SEC’s order instituting

With the approval, the company now intends to begin the PRTX-100-203 trial at several sites in France with patient enrollment expected to start by this year end. Furthermore,

The first half of the prize has been awarded jointly to Ireland born William Campbell and Japanese scientist Satoshi Omura by the Nobel Assembly at Karolinska Institutet for

The approval of PD-L1 IHC 22C3 pharmDx strengthens Dako’s portfolio of companion diagnostics and the company’s leadership position in developing and commercializing companion diagnostic products. Dako developed PD-L1

Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. Under FDA’s accelerated approval regulations, this

The SOLUTION clinical study is designed to evaluate the efficacy and safety of Sollpura, a microbial derived, biotech pancreatic enzyme replacement therapy (PERT), compared to an approved, porcine-derived,

It aims to lower the risks of disease progression and hospitalization for worsening PAH, and enhance exercise ability. The approval followed a study in which the Letairis/tadalafil combination