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The EMA is mapping out trial designs for the development of therapies to treat Crohn’s disease, ulcerative colitis and mycobacterium tuberculosis. Read More
The fallout continues from a series of deaths in Juno Therapeutics’ leukemia trial, as the company disclosed that it experienced four patient deaths, not three as it had previously reported. Read More
The EMA is advising drugmakers to rely on two types of analyses — metabolic and mechanism of action — to determine the minimum effective dosage for antimicrobial drugs. Read More
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