When the FDA approved this drug, there was an additional demand from the FDA to conduct post-marketing studies and assess the drug’s safety. Recently, a non-profit consumer advocacy group sent a petition requesting that the FDA should eliminate the drug from the U.S. pharma market since the drug shows significant risk of cardiovascular diseases.
Takeda has upped its offer to buy Shire $SHPG for a mix of stock and cash worth close to $65 billion, which is good enough for the Lexington, MA-based biotech to extend the deadline on their talks to May 8 after determining they were close to finalizing a pact.
First allogeneic stem cell therapy to receive central marketing authorization approval in Europe. Alofisel offers a new treatment option for patients who do not respond to current available therapies and may be subject to numerous invasive surgeries1
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