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The European Medicines Agency is advising drugmakers to create a separate program to assess the effectiveness of risk-minimization efforts for each marketed drug. Read More
Drug companies could pay as much as US $330,000 per authorized product to cover postmarketing assessments required by the EU’s new pharmacovigilance law, under fees proposed by European lawmakers. Read More
The FDA has rejected Avedro’s NDA for its riboflavin ophthalmic solution/KXL System, saying additional data supporting the drug-device combo’s efficacy and safety are required for approval. Read More
Australia’s Therapeutic Goods Administration (TGA) said Tuesday it is evaluating the potential safety risks of Biogen Idec’s multiple sclerosis drug Tysabri following reports of melanoma occurring in patients using the drug. Read More
The FDA has extended by three months the PDUFA-review date for Biogen Idec’s Plegridy, a drug candidate proposed to treat relapsing multiple sclerosis (MS), the drugmaker said Tuesday. Read More
Pierre Fabre has received FDA approval for its oral drug Hemangeol, indicated to treat proliferating infantile hemangioma (IH) requiring systemic therapy. Read More
NICE, the UK’s healthcare costs watchdog, has positively appraised Boehringer Ingelheim’s (BI) non-small-cell lung cancer (NSCLC) treatment, Giotrif. Read More
The FDA wants sponsors submitting bioavailability (BA) and bioequivalency (BE) data in support of an orally administered new drug to conduct pharmacokinetic studies of their products. Read More
UK regulators have created a pathway to speed life-saving drugs to patients under an early-access program, which officials liken to the FDA’s popular breakthrough therapy initiative. Read More
The UK’s healthcare costs watchdog has once more rejected Celgene’s blockbuster cancer drug Revlimid for a new indication. This time, the National Institute for Health and Care Excellence (NICE) says the drug failed to show clear efficacy and cost-effectiveness as a second-line treatment for multiple myeloma. Read More