FDA Approves First-Ever RNAi Drug

FDA Approves First-Ever RNAi Drug

In science, and especially in the biotech sphere, it’s easy to be allured by the sudden breakthrough—the quick and glamorous new drug. But, in that sense, the field of RNA interference has been a bit of an anomaly. Nearly a generation passed between the promise of a drug therapy that muted specific disease-causing genes and […]

FDA widens its recall of tainted blood pressure drugs

FDA widens its recall of tainted blood pressure drugs

Do you know someone with high blood pressure? Be aware that the FDA has widened its recall of tainted blood pressure medication containing the drug valsartan. A limited recall began in July but has since been expanded to this list of drugs. The impurity in question, N-nitrosodimethylamine or NDMA, which was detected in several batches, […]

FDA Grants Orphan Drug Designation in Second Indication for Pulmonary Arterial Hypertension

FDA Grants Orphan Drug Designation in Second Indication for Pulmonary Arterial Hypertension

This morning, August 14, 2018, the US Food and Drug Administration (FDA) granted an orphan drug designation in a second indication to Martin Pharmaceuticals’ trimetazidine dihydrocholoride (LIVANTRA) for the treatment of pulmonary arterial hypertension (PAH). Previously, LIVANTRA was granted an orphan drug designation by the FDA for the treatment of acute-on-chronic liver failure (ACLF). “The […]

Martin Pharmaceuticals' LIVANTRA™ Receives FDA Orphan Drug Designation in Second Indication

Martin Pharmaceuticals' LIVANTRA™ Receives FDA Orphan Drug Designation in Second Indication

NEW YORK–(BUSINESS WIRE)–Martin Pharmaceuticals, a clinical stage pharmaceutical company focused on repurposing already-approved drugs to offer life-changing advances to patients afflicted with rare (orphan) diseases or challenging medical conditions, announced today that it has been granted Orphan Drug Designation by the U.S. Food & Drug Administration (FDA) for LIVANTRA™ in the treatment of Pulmonary Arterial […]

Poppy seed wash is really a drug, FDA says

Poppy seed wash is really a drug, FDA says

Get breaking news alerts and special reports. The news and stories that matter, delivered weekday mornings. SUBSCRIBE A product called Poppy Seed Wash is advertised as a natural alternative to opioids for relaxation and pain relief, but it’s really just an unlicensed drug, the Food and Drug Administration said Tuesday. The FDA posted a warning […]

FDA Grants Orphan Drug Designation to Onspira Therapeutics' Investigational Interleukin-1 Receptor Antagonist for the …

FDA Grants Orphan Drug Designation to Onspira Therapeutics' Investigational Interleukin-1 Receptor Antagonist for the …

WAYNE, Pa.–(BUSINESS WIRE)–Onspira Therapeutics, a privately-held clinical-stage biopharmaceutical company dedicated to developing therapies to treat rare, life threatening pulmonary diseases, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its investigational product, OSP-101, for the treatment of Bronchiolitis Obliterans (BO). BO is a progressive inflammatory condition resulting in airflow […]

FDA Publishes Draft Guidance Seeking Innovative Approaches for Nonprescription Drug Product Labeling and …

FDA Publishes Draft Guidance Seeking Innovative Approaches for Nonprescription Drug Product Labeling and …

In an effort to provide approval of a wider range of nonprescription drug products, the U.S. Food and Drug Administration (FDA) has issued a draft guidance, entitled “Innovative Approaches for Nonprescription Drug Products.”  The FDA approves new drug applications (NDAs) for nonprescription drug products based on information that ensures the drug product is safe and […]

FDA to Study Drug Risk Information in DTC Print Ads

FDA to Study Drug Risk Information in DTC Print Ads

Posted 13 August 2018 | By Ana Mulero  The US Food and Drug Administration (FDA) said Monday it plans to conduct an experimental study on consumer impact from the amount and placement of risk information in prescription drug ads.   Sponsors tend to include risk information in both the “Important Safety Information” (ISI) section in […]

FDA rethinks approach to testing new heartworm drugs

FDA rethinks approach to testing new heartworm drugs

Alan R. Walker photo via Wikimedia Commons An infected dog’s heart shows a cluster of adult heartworms. The U.S. Food and Drug Administration is considering changing what it asks of drugmakers to demonstrate efficacy of new heartworm preventive medications in dogs, in light of the parasite’s evolving resistance to drugs. The agency is […]