Food and Drug Administration (FDA)
NEWS
Two days after the FDA approved a powerful new sublingual opioid medication, FDA Commissioner Scott Gottlieb used his Twitter account to defend the approval amid concerns that the medication is susceptible to abuse.
The U.S. FDA approved Pfizer’s Lorbrena (lorlatinib) for ALK-positive metastatic non-small cell lung cancer (NSCLC) in patients whose disease hasn’t progressed on crizotinib and at least one other ALK inhibitor or for patients whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor.
Although there is some slowdown as the FDA moves into the holiday season in late November and into December, there are still upcoming target action dates. Here’s a look at this week’s PDUFA dates.
It was 36 years ago when Food and Drug Administration (FDA) approved Eli Lilly and Company’s Humulin, the first human Recombinant insulin for diabetes treatment.
MAPS is testing MDMA in a Phase III trial and hopes to seek regulatory approval by 2021.
Alkermes now faces a difficult uphill battle to gain regulatory approval for ALKS-5461 as a treatment for MDD.
Biopharma companies set to release financial reports next week have reported positive news in recent months.
This year has been a strong one for biotech initial public offerings (IPO). According to the Wall Street Journal, as of mid-October, 55 biotech companies had raised $5.75 billion.
The U.S. Food and Drug Administration issued a voluntary recall of a medication to treat high blood pressure due to trace amounts of a carcinogen being found within some lots of the drug.
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