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.
Within the next six years, the multiple myeloma market is projected to be $37.5 billion – an incredible growth of $30 billion since 2015, when the market was valued at about $7.5 billion.
Pfizer’s Xalkori, the first drug approved in the United States for patients with ALK-positive and ROS1-positive non-small cell lung cancer, secured Breakthrough Therapy Designation from the U.S. Food and Drug Administration for two new indications.
Following the long holiday weekend, three pharma companies began the week with good news as the U.S. Food and Drug Administration awarded their therapies with Priority Review Status.
The Memorial Day Holiday is making the U.S. Food and Drug Administration (FDA)’s schedule a bit more complicated. Here’s a look at two more FDA decisions coming up this week.
The U.S. Food and Drug Administration (FDA) gave BioMarin Pharmaceutical a thumbs-up for its Palynziq (pegvaliase-pqpz) to treat phenylketonuria (PKU).
Sun Pharma received approval from the U.S. Food and Drug Administration (FDA) for Yonsa (abiraterone acetate) to treat metastatic castration-resistant prostate cancer (mCRPC). Sun will launch the drug in the U.S. via a licensing deal with Churchill Pharmaceuticals, the original developer of the drug.
Dova Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) approved its Doptelet (avatrombopag) to treat thrombocytopenia in adults with chronic liver disease scheduled to undergo a procedure.
The third time is the charm for AstraZeneca and its hyperkalemia treatment that has been dogged by manufacturing issues. After multiple rejections, the U.S. Food and Drug Administration finally gave its approval for the treatment.
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