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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
Sandoz wasted no time in launching its generic version of Copaxone in the U.S. after the U.S. Court of Appeals for the Federal Circuit again invalidated Teva’s patent on the blockbuster multiple sclerosis drug. 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
Aimmune Therapeutics has won FDA breakthrough therapy designation for AR101, an oral immunotherapy for children and adolescents with peanut allergies. Read More