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The Senate HELP Committee unanimously passed a bill that would allow drugs to be sold before the Drug Enforcement Agency permanently assigns them to a controlled substance schedule to help extend their marketing exclusivity. Read More
An interim report shows that, since 2013, the FDA has conducted nearly 90 meetings with more than 50 drug companies interested in producing biosimilar products — at a cost of $65.9 million. Read More
The FDA has approved Impax’s generic versions of Valeant’s Mestinon Timespan tablets and Testred capsules, the first two products approved at the company’s Hayward, Calif., manufacturing plant following resolution of a 2011 warning letter. Read More
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