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An FDA advisory committee unanimously recommended the agency approve five indications for Amgen’s biosimilar of AbbVie’s blockbuster drug Humira. Read More
With an eye toward advancing personalized medicine, the FDA is mapping out the development of therapies with companion devices, offering companies a slew of pathways. Read More
EMA is proposing a broader scope for guidelines on initial human trials to address emergent practices and safety issues linked to participant deaths. Read More
An FDA advisory committee unanimously backed FDA approval of Valeant’s Siliq to treat plaque psoriasis, but was split on the risk management of the candidate due to reported suicides. Read More
The UK’s drug pricing watchdog has recommended that the National Health Service reimburse for Amgen’s melanoma therapy Imlygic, provided that the company lowers the price. Read More
The FDA is turning up the heat on pharmaceutical firms for a range of GMP violations, firing off warning letters to three companies over issues ranging from data integrity to risk management. Read More