Eisai's supplemental application for Fycompa CIII accepted
Eisai Inc.'s supplemental New Drug Application for Fycompa CIII has been accepted by the U.S. Food and Drug Administration. Read More »
Lexicon and Ipsen's MAA for Xermelo given positive opinion by CHMP
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 »
European agency approves Tocagen's treatment for high grade glioma
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 »
Health Canada to review Sunovion's schizophrenia treatment
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 »
Chinese officials accept study application for GBM treatment
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 »
FDA accepts Amgen’s BLA for Aimovig (erenumab)
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 »
FDA clears first neonatal MRI device
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 »
FDA approves Sanofi's Kevzara for rheumatoid arthritis treatment
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 Pharmaceuticals moves ahead with psoriasis-treating drug
Sun Pharmaceutical Industries Ltd.'s Biologics License Application for tildrakizumab has been accepted by the U.S. Food and Drug Administration. Read More »
Committee OKs proposed anemia drug from Pfizer
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 receives expanded approval for lymphoma drug
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 »
Arcadia water-use efficiency trait passes early FDA assessment
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 »
Vosevi gains FDA approval as chronic hepatitis C drug
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 »
Principia Biopharma’s PRN1008 gains FDA orphan drug status
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 »
FDA approves Lannett's Cyproheptadine Hydrochloride Syrup
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 »
Novoteris receives FDA approval to begin cystic fibrosis treatment
Novoteris LLC's Phase 2 clinical trial application for inhaled nitric oxide as a treatment for cystic fibrosis has been approved by both the U.S. Food and Drug Administration and the Therapeutic Products Directorate of Health Canada. Read More »
FDA reviews Pfizer's application for Sutent
Pfizer Inc. recently announced that the U.S. Food and Drug Administration (FDA) accepted the company’s supplemental New Drug Application (sNDA) for Sutent. Read More »
HedgePath Pharma seeks FDA guidance on its SUBA-Cap trial
HedgePath Pharmaceuticals Inc. (HPPI) recently announced that the U.S. Food and Drug Administration (FDA) granted the company’s Type-C Guidance Meeting Request for further guidance on HPPI’s Phase 2(b) clinical trial analyzing SUBA-Itraconazole (SUBA-Cap) oral capsule usage in patients with Basal Cell Carcinoma Nevus Syndrome (BCCNS), also known as Gorlin Syndrome. Read More »
Sunovion’s new drug application for Latuda earns FDA review
Sunovion Pharmaceuticals Inc.'s supplemental New Drug Application for a medication addressing bipolar conditions has won acceptance for review by the U.S. Food and Drug Administration. Read More »
Endo International offers Opana ER update
Endo International plc has voluntarily opted to withdraw its Opana ER (oxymorphone hydrochloride extended release) product from the market after an FDA request in June, following a thorough review period and collaboration with the agency. Read More »
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