Food and Drug Administration (FDA)

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Pharmaceutical execs who leave their positions with big pharmaceutical companies, unless opting to retire for good, often move to leadership positions at other big companies. There are other choices.
Barring yet another headline-leading scandal, confrontational tweet or TV talk-show rant, Trump is expected to offer a speech on his administration’s policies toward drug pricing this week.
As we get closer to seeing the U.S. Food and Drug Administration green light the first gene therapy for hemophilia, analysts estimate that the cost of the probable one-time treatment could have a whopping price-tag of $1.5 million.
The U.S. Food and Drug Administration (FDA) granted Genentech’s Tecentriq triple combination with Avastain (bevacizumab), paclitaxel and carboplatin (chemotherapy) Priority Review for first-line treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC).
On May 1, the U.S. Food and Drug Administration (FDA) granted Scynexi’s oral formulation of SCY-078 to treat vulvovaginal candidiasis (VVC) and recurrent VVC both Qualified Infectious Diseases Product (QIDP) and Fast Track Designation.
Regeneron has halted high dose treatment of a Phase III osteoarthritis drug following a risk-benefit assessment conducted by an Independent Data Monitoring Committee.
Just about every week has plenty of exciting news in the biopharmaceutical industry, and this week was no different. Here’s a brief look back at some of our top stories.
Shares of Achaogen are down more than 30 percent in premarket trading following the results of split support from a U.S. Food and Drug Administration panel for its lead antibiotic treatment, plazomicin, which is being developed for the treatment of adults with complicated urinary tract infections and bloodstream infections.
The U.S. Food and Drug Administration (FDA) issued a complete response letter (CRL) to Sandoz, a division of Novartis, for its Biologics Licensing Application (BLA) for its biosimilar to Roche/Genentech’s Rituxan.
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