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The judge says the FDA did not unlawfully decide to delay final approval of Veloxis Pharmaceuticals’ extended-release immunosuppression drug. Read More
The U.S. Court of Appeals for the Federal Circuit has affirmed a lower court ruling that Celgene did not infringe on a Teva subsidiary’s patent when it marketed its cancer drug Abraxane. Read More
The International Conference on Harmonisation has released a Q&A guide aimed at clarifying requirements for quality management, documentation, equipment cleaning and more in its Q7 guideline on GMPs for active pharmaceutical ingredients. Read More
The National Institutes of Health is working quickly to correct major lapses in its drug compounding unit so officials will be able to ask the FDA to register it as a cGMP manufacturing facility subject to periodic regulatory inspections. Read More
Valeant Pharmaceuticals is recalling more than 93,000 bottles of nifedipine extended-release 90 mg tablets throughout the U.S. because they dissolve too quickly. Read More
India’s national drugs authority is planning to hire 147 inspectors this year to ensure adherence to good manufacturing practice standards, although proper training will prove essential for success, one observer says. Read More
Eisai has received FDA approval of an expanded indication for its antiepileptic drug Fycompa as an adjunctive treatment for primary generalized tonic-clonic seizures in epilepsy patients 12 and older. Read More
The designation comes with a seven-year period of U.S. marketing exclusivity, assistance with clinical trial design and waiver of PDUFA filing fees. Read More