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Israeli drugmaker Teva will pay $24 million to settle a pay-for-delay lawsuit over its generic version of AstraZeneca’s heartburn relief drug Nexium. Read More
The judge says the FDA did not unlawfully decide to delay final approval of Veloxis Pharmaceuticals’ extended-release immunosuppression drug. 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
Citing cost concerns, the UK’s healthcare watchdog is recommending against Celgene’s Otezla alone or in combination with disease-modifying antirheumatic drug therapies for adults with active psoriatic arthritis. Read More
The European Commission has approved Bristol-Myers Squibb’s Opdivo as both a first-line and second-line treatment for adults with advanced melanoma, allowing the drug to be marketed in all 28 member states. Read More
Concerned about high treatment costs, the UK’s healthcare cost watchdog wants Gilead Sciences to provide more information on its blockbuster leukemia drug Zydelig before it will consider recommending its use. Read More