FDA
The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.
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The Senate failed to pass a massive spending bill on Thursday—which includes the rare pediatric PRV program but also funding for the Immigration and Customs Enforcement’s large-scale crackdown in Minnesota and other states.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
Together with robust data-driven modeling, rethinking regulation and data use could push forward a notoriously challenging field.
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Following a meeting with the U.S. Food and Drug Administration Sage Therapeutics is seeing the goal line for potential expedited approval of its major depressive disorder (MDD) and postpartum depression (PPD) treatment, SAGE-217.
The medical device market was about $521.2 billion last year and is projected to hit $674.5 billion by 2022. Here’s a look at the top 10 medical device companies in the world this year.
The U.S. Food and Drug Administration (FDA) approved AbbVie and Roche’s combination of Venclexta in combination with Rituxan (rituximab) to treat chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion in patients who have received at least one previous therapy.
Ironwood Pharmaceuticals, headquartered in Cambridge, Massachusetts, announced the U.S. Food and Drug Administration (FDA) had granted its olinciguat (IW-1701) Orphan Drug Designation for sickle cell disease.
The U.S. Food and Drug Administration (FDA) approved Genentech’s Rituxan (rituximab) to treat adults with moderate to severe pemphigus vulgaris (PV).
There are generally two types of antidepressants on the market. They are selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs). But there are still individuals who do not respond well to these drugs and the industry continues to work on developing better and alternative treatments for depression.
BioMarin Pharmaceutical received $20 million in milestone payments from Pfizer after the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) approved its applications for talazoparib.
As the 2018 BIO International Convention wraps up in Boston today, it kicked off with a fireside chat with Dr. Scott Gottlieb, Commissioner of the U.S. Food and Drug Administration (FDA).
The U.S. Food and Drug Administration (FDA) approved Mylan’s Fulphila (pegfilgrastim-jmbd), a biosimilar to Amgen’s Neulasta (pegfilgrastim). The biosimilar was co-developed with Biocon.
Florida-based TherapeuticsMD is feeling a bit vindicated this morning after the U.S. Food and Drug Administration approved its vaginal pain medication.