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The FDA’s crackdown on compounders continues with two pharmacies receiving warning letters for compounding drugs without a prescription, mixing an unapproved drug ingredient into compounded products and failing to maintain sanitary facilities. Read More
The surge of opposition to Zogenix’s controversial painkiller Zohydro ER shows no signs of abating, with state officials joining congressional critics in calling for a reversal of the single-entity hydrocodone product’s approval. 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
Shire Pharmaceuticals is recalling three lots of Gaucher disease drug Vpriv after finding stainless steel and barium sulfate particles in a small number of vials. Read More
PhRMA is seeking substantial changes to the FDA’s proposed generic drug safety labeling rule, saying the agency should pre-approve all safety labeling changes for drugs with more than one manufacturer. 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