Latest News

SELENBIO, INC.: Texas-Based Biotech Company To Launch FDA-Approved Product Geared Toward Healthier Pets

Pet lovers and veterinarians stay tuned. Texas-based SelenBio is soon to launch an effective breakthrough in helping to prevent gum disease in dogs and cats.

EMD SERONO: FDA Approves BAVENCIO® (avelumab) Plus INLYTA® (axitinib) Combination for Patients with Advanced Renal Cell Carcinoma

EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced that the US Food and Drug Administration (FDA) has approved BAVENCIO® (avelumab) in combination with INLYTA® (axitinib) for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

ELI LILY AND COMPANY: Lilly's CYRAMZA® (ramucirumab) Becomes First FDA-Approved Biomarker-Driven Therapy in Patients with Hepatocellular Carcinoma

Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has approved CYRAMZA® (ramucirumab injection, 10 mg/mL solution), as a single agent, for the treatment of patients with hepatocellular carcinoma (HCC) who have an alpha-fetoprotein (AFP) of ≥400 ng/mL and have been treated with sorafenib.

REGENERON: FDA Approves EYLEA® (aflibercept) Injection for Diabetic Retinopathy

EYLEA improves diabetic retinopathy and prevents worsening disease that can lead to blindness

MYLAN N.V.: Mylan Expands Oncology Portfolio with Launch of Generic Tarceva® Tablets

Erlotinib Hydrochloride Tablets treat metastatic non-small cell lung and pancreatic cancers

SUNOVION PHARMACEUTICALS, INC.: Sunovion and PsychoGenics Announce that SEP-363856 Has Received FDA Breakthrough Therapy Designation for the Treatment of People with Schizophrenia

SEP-363856 offers an innovative approach to the treatment of schizophrenia including the potential to be the first agent for the treatment of schizophrenia that does not bind to dopamine 2 (D2) receptors

Man who beat Lou Gehrig’s disease points to need for 'Right to Try' laws

A McDonough, Georgia man who was the first to fight of a debilitating and deadly disease points out the reasons why “right to try” legislation that is being considered in North Carolina needs to succeed, according to a Washington Post op-ed piece.

First treatment for all genotypes of hepatitis C in pediatric patients approved

Mavyret tablets were approved last week by the Food and Drug Administration for the treatment of all six genotypes of hepatitis C virus (HCV) in teenagers.

OPTINA DIAGNOSTICS: Receives Breakthrough Device Designation from U.S. FDA for a Retinal Imaging Platform to Aid in the Diagnosis of Alzheimer's Disease

Optina Diagnostics announces today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its retinal imaging platform (CAPRS1/MHRC2).

Approval of device to treat ADHD welcomed, with some caution

Parents, doctors and other stakeholders are welcoming the approval of a device to help treat children of a certain age with attention-deficit/hyperactivity disorder (ADHD), but with caution.

SAVARA, INC.: Announces Molgradex Received Fast Track Designation by FDA for Treatment of Autoimmune Pulmonary Alveolar Proteinosis

Savara Inc. (NASDAQ: SVRA), an orphan lung disease company, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for Molgradex, an inhaled formulation of recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF).

CARIS LIFE SCIENCES: Receives FDA Breakthrough Device Designation for MI Transcriptome™ Companion Diagnostic Test

This is the first companion diagnostic to detect gene fusions across all solid tumors; Caris expects to submit for Pre-Market Approval later this year

Clinical drug trial costs 'surprisingly low,' Johns Hopkins researchers find

Contrary to past drug company pronouncements, the cost of clinical trials makes up a small fraction of pharmaceutical drug development costs, a new study concludes.

FDA Health News