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Investigational New Drug application approved for LINCL treatment
The FDA has granted Investigational New Drug application to PLX-200 to treat late infantile neuronal ceroid lipofuscinosis (LINCL).
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Less than half of US clinical trials comply with reporting regulations
Researchers have found that only 41 percent of trials reported their findings with a year after completion and suggest that over $4 billion in fines could have been collected in just 12 months.
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Fast Track Designation granted to decompensated heart failure treatment
The US FDA has granted Fast Track Designation to APD418, which is in development as treatment for decompensated heart failure patients.
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FDA issues warning letter to Health Pharma for cGMP violations
An inspection at a manufacturing facility belonging to Health Pharma has revealed breaches of cGMP regulations, causing the FDA to send a warning letter.
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HIV treatment Dovato (dolutegravir/lamivudine) approved in Japan
The Japanese Ministry of Health, Labour and Welfare (#MHLW) has granted marketing approval for Dovato, a treatment for HIV-1 infection.
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FDA issues alert for cancer risk from Belviq (lorcaserin)
The US FDA has announced a warning to healthcare professionals and patients that the weight management drug Belviq may be a cause of cancer.
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FDA grants Avatrombopag Orphan Drug Designation for thrombocytopenia
The US FDA has granted avatrombopag (Doptelet) ODD as around 10 percent of US cancer patients per year experience chemotherapy-induced thrombocytopenia (CIT) with no available treatment.
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FDA approves Keytruda for patients with high-risk, non-muscle invasive bladder cancer
Keytruda is the first anti-PD-1 monoclonal antibody therapy approved for patients with BCG-unresponsive, high-risk, non-muscle invasive bladder cancer.
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Taro Pharmaceuticals voluntarily recalls one lot of lamotrigine tablets
Due to cross-contamination with enalapril maleate, Taro is voluntarily recalling one lot of its lamotrigine tablets at the consumer level.
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T-cell lymphomas treatment trial update announced by Innate Pharma
Enrolment of new patients in the TELLOMAK trial, which has been evaluating the efficacy and safety of lacutamab in patients with advanced T-cell lymphomas, has been suspended.
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FDA approves Ayvakit, the first targeted gastrointestinal stromal tumour treatment
The FDA has approved Ayvakit for the treatment of GISTs with platelet-derived growth factor receptor alpha mutations, following 84 percent response rate in clinical trials.
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Establishing a new pharmaceutical track and trace system in Dubai
Health authorities in Dubai have announced that they will introduce a new track and trace system to the emirate by mid-2020. This article investigates how this will help to improve the safety and quality of medicinal products.
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FDA announces one nizatidine and two ranitidine voluntary recalls
Mylan, Appco Pharma and Denton Pharma are voluntarily recalling nizatidine and ranitidine products due to potential unacceptable levels of NDMA.
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Acute myeloid leukemia treatment receives FDA Orphan Drug Designation
Orphan drug designation has been approved by the FDA for PRGN-3006 UltraCAR-T™ for patients with acute myeloid leukemia (AML).
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FDA announces new centre to improve compounded drug quality
A new centre has been established by the FDA that will allow the agency to improve the quality and safety of compounded drugs by providing educational programmes to outsourcing facilities.