In 2015, the FDA by its own account approved 45 new drugs, the largest one-year tally since 1996, which wrapped up with a record 53 regulatory OKs. Now, here's the full list of new drugs approved by the FDA in 2015, in chronological order.
The FDA has approved United Therapeutics' Unituxin (dinutuximab) to treat pediatric patients with high-risk cases of neuroblastoma. And the regulatory win comes with a priority review vouch that may well be worth tens of millions of dollars.
SteadyMed Therapeutics is heading to Nasdaq in search of $55 million (€49 million) to finance its assault on United Therapeutics' slice of the pulmonary arterial hypertension (PAH) market. The goal is to win market share by offering patients a simpler parenteral treatment for PAH.
Carving out a successful career in biopharma isn't easy, for men or women. The failure rate of experimental drugs is astronomically high. And just because a company wins an approval is no...
A few weeks ago, we published our annual list of highest-paid biopharma CEOs. Now, we're saying whoops! Sitting at the top of our list was Regeneron CEO Leonard Schleifer with $36.27 million in 2013 compensation. But United Therapeutics chief Martine Rothblatt should have had that spot.
Christmas has arrived early for United Therapeutics. The biotech took most analysts completely by surprise with the news that the FDA had stamped an approval on Orenitram (treprostinil, or oral Remodulin) after twice snubbing its application for the pulmonary arterial hypertension drug.
The Department of Health and Human Services has just added United Therapeutics to the growing list of companies under scrutiny for their marketing practices, calling into question three of its pulmonary arterial hypertension drugs--the only three products it sells.
United Therapeutics is going to have to revise its timeline on an oral successor to its bestselling Remodulin one more time. The FDA has handed United its second CRL in a matter of months, once again batting down its hopes of launching a new drug into an increasingly crowded market.
The budget cuts required by sequestration may have added a big question mark to every FDA deadline on the schedule, but there are four big developers holding their breath right now in anticipation of a formal marketing decision on their experimental drugs.
Analysts at GlobalData took a quarterly snapshot of the R&D expenses for a big batch of mid-cap biotechs and concluded that rising research costs were eroding corporate profitability. And they pinned the blame squarely on the pricey hunt for new cancer drugs.