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The guidance is expected to take 3-4 months pending the response from the MHRA in the UK. Under a European system called the "Decentralized Procedure" (DCP), a company

"We are extremely pleased with the grant of orphan drug designation for our lead compound in CML. This is an important step in gaining commercial interests for a

The companies will develop next generation, precision-controlled chimeric antigen receptor (CAR) product candidates that feature Cell Design Labs’ molecular on/off switch technology. Under the deal, Cell Design Labs

Olmutinib is a third-generation, epidermal growth factor receptor (EGFR) mutation-specific tyrosine kinase inhibitor (TKI) intended to treat EGFR mutation-positive non-small cell lung cancer (NSCLC). Boehringer Ingelheim will evaluate

Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its supplemental Abbreviated New Drug Application (sANDA) and was awarded 180 days of marketing exclusivity

PRIME provides early and enhanced regulatory support to optimize regulatory applications and speed up the review of medicines that address a high unmet need. KTE-C19 is an investigational

PNH is a ultra-rare, life-threatening blood disorder in which the immune system destroys red blood cells. The benefits of orphan drug status in the EU include a 10-year

The revefenacin phase 3 program, which includes two replicate efficacy trials and a single twelve-month safety study, is designed to support the product’s registration in the US. Theravance

Afinitor is now approved to treat unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) NET of GI or lung origin in adults with progressive disease. The approval