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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The FDA approved Gilead’s triple combination treatment for HIV, Biktarvy.
Topcon’s touted its system as being able to quickly penetrate ocular tissues without being obscured by hemorrhage or media opacities.
Ra Medical only has five full-time salespeople on staff, but expects that to grow to 20 to 25 people later this year.
The company believes the Translarna data is compelling and pointed to the success the drug is having in Europe.
2017 was the second-best year for FDA approvals since 1996.
The FDA approved Merck’s and Pfizer’s Steglatro, a SGLT2-inhibitor, that will square off against established drugs in the market.
The FDA broke new ground today with a first-of-its-kind therapy for eye disease.
Christmas came a week early for Aerie Pharmaceuticals.
The approval of HAnano Surface in the United States has been executed in accordance with the new 510(k) legislation for medical devices.
A look at the latest batch of FDA approvals this year.