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The New England Compounding Center (NECC), at the heart of a nationwide fungal meningitis outbreak, dropped the ball after seeing early signs of unacceptable levels of microbial contamination, the FDA says.
Teva plans to launch its orphan chronic myeloid leukemia (CML) drug Synribo by mid-November after getting accelerated approval Friday.
Watson Pharmaceuticals was dealt a blow last week when the FDA denied its formal dispute resolution request (FDRR) seeking approval for its progesterone vaginal gel.
The UK’s National Institute for Health and Clinical Excellence (NICE) has recommended Pharmaxis’ Bronchitol as a cost-effective treatment for some adults with cystic fibrosis (CF).
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