Formulated to detect the presence of the potent opioid fentany in urine, California-based Immunalysis Corp.’s branded immunoassay Sefria — the first of its kind — recently achieved 510(k) clearance from the U.S. Food and Drug Administration. Read More »
Filling a need for those youngsters who fear needles or find pills unmanageable, Denver-based Silvergate Pharmaceuticals Inc. recently released Xatmep, the first methotrexate oral solution to gain approval from the U.S. Food and Drug Administration. Read More »
In answer to New Jersey-based Eagle Pharmaceuticals Inc.’s New Drug Application (NDA) for Ryanodex (dantrolene sodium) to treat exertional heat stroke (EHS), the U.S. Food and Drug Administration (FDA) recently issued a Complete Response Letter. Read More »
New Jersey-based specialty generic pharmaceutical manufacturing firm Teligent recently obtained U.S. Food and Drug Administration approval — its third in 2017 — for its Abbreviated New Drug Application (ANDA) regarding its Erythromycin Topical Gel USP, 2%. Read More »
Because acute myeloid leukemia (AML) impacts relatively few individuals nationwide, gilteritinib — an anti-cancer medication developed by Tokyo-based Astellas Pharma Inc. — recently attained orphan-drug designation from the U.S. Food and Drug Administration. Read More »
Eisai Inc.'s supplemental New Drug Application for Fycompa CIII has been accepted by the U.S. Food and Drug Administration. Read More »
Lexicon Pharmaceuticals Inc.'s Xermelo, a carcinoid syndrome diarrhea treatment created in collaboration with Ipsen, has been given a positive opinion for Marketing Authorization Application by the Committee for Medicinal Products for Human Use, the committee of the European Medicines Agency responsible for human medicines. Read More »
Tocagen Inc., a clinical-stage, cancer-selective gene therapy company, recently announced that its Toca 511 was awarded PRIME designation by the European Medicines Agency for treating high grade glioma patients. Read More »
Sunovion Pharmaceuticals Inc. of Marlborough, Massachusetts recently gained approval for its supplemental new drug submission regarding Latuda (lurasidone HCI) — aimed at relieving adolescent schizophrenia — from Health Canada, potentially extending the treatment’s age range. Read More »
DelMar Pharmaceuticals' application for a Phase II study evaluating a treatment for newly diagnosed MGMT-unmethylated glioblastoma multiforme has been accepted by the Human Genetic Resources Administration of China. Read More »
California-based Amgen recently obtained U.S. Food and Drug Administration (FDA) acceptance of its Biologics License Application (BLA) for Aimovig (erenumab), a product developed specifically to help victims of frequent migraine headaches. Read More »
To better tend babies in the nation’s neonatal intensive care units, the first magnetic resonance imaging (MRI) device designed for newborns recently garnered U.S. Food and Drug Administration approval following thorough safety confirmation. Read More »
Sanofi and Regeneron Pharmaceuticals Inc. recently announced that Kevzara (sarilumab), a treatment for adult patients with moderately to severely active rheumatoid arthritis who have not responded well to one or more disease modifying antirheumatic drugs, has been approved by the U.S. Food and Drug Administration. Read More »
Sun Pharmaceutical Industries Ltd.'s Biologics License Application for tildrakizumab has been accepted by the U.S. Food and Drug Administration. Read More »
Pfizer Inc.'s proposed epoetin alfa biosimilar has been recommended for approval across all indications by the U.S. Food and Drug Administration's Oncologic Drugs Advisory Committee. Read More »
Novartis' Zykadia, a treatment for patients with metastatic non-small cell lung cancer whose tumors are anaplastic lymphoma kinase-positive, has been approved for expanded use by the U.S. Food and Drug Administration. Read More »
Agricultural technology firm Arcadia Biosciences Inc. has successfully attained an Early Food Safety Evaluation from the U.S. Food and Drug Administration determining that its functional protein product is safe for humans and animals. Read More »
Chronic hepatitis C virus (HCV) patients have a new treatment option with the approval of Vosevi (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg) by the U.S. Food and Drug Administration. Read More »
PRN1008 — acting as a reversible covalent Bruton’s Tyrosine Kinase (BTK) inhibitor — has attained orphan drug designation by the U.S. Food and Drug Administration (FDA) for treating pemphigus vulgaris, its producer Principia Biopharma Inc. announced recently. Read More »
Lannett Company Inc. of Philadelphia recently obtained and subsequently announced FDA approval of its Abbreviated New Drug Application (ANDA) for Cyproheptadine Hydrochloride Syrup (Cyproheptadine Hydrochloride Oral Solution, USP) in 2 mg/5 mL dosage form. Read More »
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