The FDA has granted Investigational New Drug application to PLX-200 to treat late infantile neuronal ceroid lipofuscinosis (LINCL).
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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.
The US FDA has granted Fast Track Designation to APD418, which is in development as treatment for decompensated heart failure patients.
An inspection at a manufacturing facility belonging to Health Pharma has revealed breaches of cGMP regulations, causing the FDA to send a warning letter.
The Japanese Ministry of Health, Labour and Welfare (#MHLW) has granted marketing approval for Dovato, a treatment for HIV-1 infection.
The US FDA has announced a warning to healthcare professionals and patients that the weight management drug Belviq may be a cause of cancer.
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.
Keytruda is the first anti-PD-1 monoclonal antibody therapy approved for patients with BCG-unresponsive, high-risk, non-muscle invasive bladder cancer.
Due to cross-contamination with enalapril maleate, Taro is voluntarily recalling one lot of its lamotrigine tablets at the consumer level.
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.
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.
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.
Mylan, Appco Pharma and Denton Pharma are voluntarily recalling nizatidine and ranitidine products due to potential unacceptable levels of NDMA.
Orphan drug designation has been approved by the FDA for PRGN-3006 UltraCAR-T™ for patients with acute myeloid leukemia (AML).
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.