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July 12th 2025
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FDA Grants Accelerated Approval to Lorlatinib for ALK+ NSCLC
November 4th 2018The FDA has granted lorlatinib (Lorbrena) an accelerated approval for the treatment of patients with ALK-positive metastatic non–small cell lung cancer (NSCLC) who have progressed on 1 or more ALK tyrosine kinase inhibitors.
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FDA Grants Approval to Biosimilar for Patients Receiving Myelosuppressive Chemotherapy
November 3rd 2018Officials with the FDA have approved Coherus BioSciences’ Udenyca™ (pegfilgrastim-cbqv) for patients with cancer receiving myelosuppressive chemotherapy. The drug is a biosimilar to Amgen’s Neulasta (pegfilgrastim).
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Sufentanil Sublingual Tablet (Dsuvia) Gets FDA Approval
November 3rd 2018The approval is based on data from a multicenter trial in which patients were randomized 2:1 to receive either 30 mcg of the sufentanil sublingual tablet as needed, or placebo, with treatment limited up to 48 hours following the procedure.
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FDA OKs Biosimilar Adalimumab for Autoimmune Conditions
November 1st 2018The FDA has approved Sandoz’s biosimilar adalimumab, Hyrimoz (adalimumab-adaz) for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn disease, ulcerative colitis, and plaque psoriasis.
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Hormone Therapy Combination Granted FDA Approval for Treating Menopausal Women
October 29th 2018According to TherapeuticsMD, Bijuva is the first and only FDA-approved bio-identical hormone therapy combination of estradiol and progesterone in a single, oral capsule for the treatment of moderate to severe vasomotor symptoms due to menopause in women with a uterus.
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Separating Prescription From Illicit Fentanyl
October 29th 2018Despite a decline in the rate of opioid prescribing, the CDC reports that the number of opioid related deaths continues to rise. The pharmacology and pharmacokinetics of prescription and illicit fentanyl could help to shed light on why the opioid epidemic has taken the path that it has.
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