More than half of 2018 is already over. FDA has approved the marketing of 30 drugs by August 11, 2018. And the big pharmaceutical enterprises have successively released their 2018 H1 financial reports. Here, I’d like to list the FDA’s review progress of noteworthy pharmaceutical products in the second half of 2018 mainly according to the disclosed data. Presumably, FDA is expected to approve 51 new drugs in 2018.

I. Drugs approved by FDA expected to reach 51 in 2018, and the world’s 6th anti-PD-(L)1 antibody Cemiplimab to be marketed soon
More than half of 2018 is already over. FDA has approved the marketing of 30 drugs so far. Here, I’d like to list the review progress of noteworthy pharmaceutical products in the second half of 2018 according to the disclosed information of enterprises. Presumably, the total of drugs approved by FDA in 2018 will exceed that in 2017 to exceed 50, with the drug information as follows:
|
Drug |
Indication |
Mechanism of action |
PDUFA |
Company |
Application type |
|
Stannsoporfin |
Hyperbilirubinemia |
N/A |
August 22, 2018 |
Mallinckrodt plc |
NDA |
|
Lanadelumab |
Hereditary angioedema |
Anti-KLK monoclonal antibody |
August 26, 2018 |
Shire |
BLA |
|
Eravacycline |
Complicated urinary tract infection |
Tetracycline |
August 28, 2018 |
Everest Medicines; Tetraphase Pharmaceuticals |
NDA |
|
Volanesorsen |
Familial hyperchylomicronemia syndrome |
apolipoprotein C3 antisense nucleic acid |
August 30, 2018 |
Ionis |
NDA |
|
Dacomitinib |
NSCLC |
EGFR tyrosine kinase inhibitor |
September 2018 |
Pfizer |
Read More
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