FDA issues warning letter which highlights the importance of a quality unit
Henan Kangdi Medical Devices Co Ltd has been sent a warner letter after an inspection found cGMP violations that included failures of the company’s quality unit.
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Henan Kangdi Medical Devices Co Ltd has been sent a warner letter after an inspection found cGMP violations that included failures of the company’s quality unit.
Aurobindo Pharma USA, Inc. has issued a voluntary nationwide recall of certain mirtazapine tablets as bottles labelled as 7.5mg may contain 15mg tablets.
The FDA has approved Lynparza as a first-line treatment after it reduced the risk of disease progression or death by 47 percent in patients.
The EMA will collaborate with other medicine regulatory bodies globally in a pilot programme to inspect sterile medicine manufacturers.
The FDA has authorised the first interoperable, automated insulin dosing controller designed to allow more choices for patients looking to customise their diabetes management.
A New Drug Application has been submitted to the FDA for lonafarnib, the first-ever treatment for Progeria and Progeroid Laminopathies.
Mergers and acquisitions in any market can define the landscape for its players. In this article, Emma Danks of Taylor Wessing reflects on recent M&A activity in the biopharmaceutical industry, highlighting influencing trends and what this might mean for the future.
The FDA has announced that a notice of proposed rulemaking has been issued that would allow for the importation of certain prescription drugs from Canada which could lead to lower prescription drug prices.
Lumasiran, an investigational drug to treat primary hyperoxaluria type 1, has met its endpoints in clinical trials.
This article highlights the 10 most popular news stories published by European Pharmaceutical Review in 2019.
Dr Stephen Hahn has been voted into the role of FDA commissioner by the US Senate, taking over the role from Ned Sharpless.
The FDA has approved Vascepa (icosapent ethyl) as a secondary therapy to reduce cardiovascular events in adults.
ViiV Healthcare has filed submissions to the FDA and EMA for the first dispersible formulation of dolutegravir (DTG) for children living with HIV.
A new report from the FDA has shown that greater competition among generic drug makers is associated with lower generic drug prices.
The FDA has granted accelerated approval to Vyondys 53 for the treatment of patients with Duchenne muscular dystrophy containing a mutation of the dystrophin gene that is amenable to exon 53 skipping.