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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
The FDA has rejected a diabetes drug co-developed by Boehringer Ingelheim and Eli Lilly due to unresolved quality issues at one of Boehringer’s plants. Read More
Sagent Pharmaceuticals is the latest drugmaker to recall products with leaky containers, notifying healthcare providers that two lots of its Zoledronic Acid Injection product may not be sterile after finding that four premix bags had been compromised. Read More
Pfizer is recalling three lots of drug products after a packaging mix-up led to a capsule of the wrong drug product in a bottle of an antidepressant. Read More