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news.FDA grants orphan drug status to Escend’s ES-3000 to treat chronic myeloid leukemia
"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
"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
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
The product targets patients with mild to moderate psoriasis. Under the collaboration agreement, Cadila Pharmaceuticals will conduct a Phase III program in India starting in 2016. Lipidor CEO
Based in California, Kalytera is a pharmaceutical company developing a portfolio of non-psychoactive cannabinoid and endocannabinoid-like medicines that it believes will address large unmet market needs. Kalytera seeks
It is the first deuterated product to be reviewed by the FDA. The agency did not request for new clinical trials. SD-809 (deutetrabenazine) is an investigational, oral, small-molecule
The CHMP recommends the approval of TYSABRI for use as a disease modifying therapy (DMT) for relapsing-remitting multiple sclerosis (RRMS) patients with highly active disease activity despite a
AP32788 targets tumors driven by EGFR or HER2 kinases and was designed to achieve selective inhibition of these kinases with exon 20 mutations. There are currently no approved
The agreement enables CFFT to use ChemDiv’s unique chemistry platform to advance promising scientific research in the field of cystic fibrosis (CF) treatment. This collaboration allows ChemDiv to
"The impact of ABSSSI and CABP among children is significant, as these infections often require hospitalization and are met with limited pediatric treatment options, particularly as resistance increases