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 »
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 »
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 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 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 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 »
Meridian Bioscience Inc. released comments on a recent Food and Drug Administration Safety Notification concerning Magellan Diagnostics. Read More »
KaloBios Pharmaceuticals Inc. of California, specializing in rare and neglected diseases, recently obtained FDA clearance for its oral anti-parasitic medication benznidazole designed to combat Chagas disease, a tropical malady transmitted to humans by insects. Read More »
Progressive women's health care company Agile Therapeutics Inc. of Princeton, New Jersey has resubmitted its Twirla hormonal contraceptive patch to the U.S. Food and Drug Administration for a New Drug Application. Read More »
Cardiome Pharma Corp. partner SteadyMed Ltd. has submitted a New Drug Application for Trevyent with the U.S. Food and Drug Administration. Read More »
New Haven, Connecticut-based Biohaven Pharmaceutical Holding Company Ltd.’s BHV-5000 compound developed to treat Rett syndrome recently attained orphan drug designation from the U.S. Food and Drug Administration (FDA), its fourth product to achieve the status. Read More »
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