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The European Commission has approved Sanofi and Regeneron’s bad cholesterol treatment Praluent, two months after it was cleared by the FDA for the U.S. market. Read More
Novo Nordisk expects to launch its once daily insulin Tresiba in the first quarter of 2016, following FDA approval of that and another diabetes treatment on Friday. Read More
The FDA has revoked its March approval of Sun Pharma’s Elepsia XR antiseizure medication, citing manufacturing quality problems at the Halol, India, facility where the drug is produced. Read More
Starting Oct. 1, pharma companies seeking to cash in on a rare pediatric disease priority review voucher must pay the FDA $2.727 million — $165,000 more than in the fiscal year ending Wednesday. Read More
An interim report shows that the FDA has conducted nearly 90 meetings with more than 50 drug companies interested in producing biosimilar products since 2013 at a cost of $65.9 million. Read More
Bausch & Lomb and Nicox are calling their once-daily eye drop for treating both open angle glaucoma and ocular hypertension a milestone in research and development in a medical area that has seen few new treatments in recent years. Read More