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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
The FDA approved eight ANDAs for AstraZeneca’s blockbuster cholesterol drug Crestor after a federal judge denied the company’s bid to stave off the approvals. Read More
The UK’s drug pricing watchdog is recommending reimbursement of PTC Therapeutics’ Translarna to treat Duchenne muscular dystrophy, provided the company complies with an access agreement. Read More
The FDA’s goals for the next version of PDUFA strike a balance between fostering innovation via real-world data usage while still preserving safety standards, PhRMA and BIO officials concluded after reviewing the agency’s proposal. 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