The UK DHSC has issued an alert that phenytoin sodium 100mg capsules made by Accord will be out of stock until May.
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NICE has said it will not recommend gilteritinib for treatment of acute myeloid leukaemia (AML) due to uncertainty around long-term survival expectancy and its cost-effectiveness.
The European Commission (EC) granted marketing authorisation for Darzalex in combination with bortezomib, thalidomide and dexamethasone (VTd) for multiple myeloma patients.
Ten priority actions have been recommended for the European medicines regulatory network to evolve its approach to data use.
FUSION IV Pharmaceuticals, Inc dba AXIA Pharmaceutical is voluntarily recalling all unused sterile drug products to the user level as they do not adhere to federal guidelines.
PQE GROUP, the international quality solution provider, at Interphex to consolidate its presence in US
PQE Group, the consulting company in the pharmaceutical field, based in Italy, has chosen “Interphex” to strengthen its presence on the US market.
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.
Janssen have applied to the EMA to extend the use of esketamine to a short-term treatment for the rapid reduction of depressive symptoms in adults with MDD who are suicidal with the intent.
NICE has recommended olaparib tablets (Lynparza, AstraZeneca) for adults with relapsed platinum-sensitive ovarian, fallopian tube or peritoneal cancer with a BRCA1 or BRCA2 mutation.
The US FDA has granted Fast Track Designation to APD418, which is in development as treatment for decompensated heart failure patients.
NICE has asked for more information on Keytruda (pembrolizumab) for untreated metastatic or unresectable recurrent squamous cell head and neck cancer due to uncertainty over clinical trial evidence.
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.
Jasper Ojela, a registered pharmacist who admitted to supplying the black market with drugs including cancer medications, has been given a 28-month prison sentence.