USFDA

- Read more about FDA grants rare pediatric disease designation to MediciNova’s MN-166 (ibudilast) for the treatment of Krabbe Disease
MediciNova, Inc., announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to MN-166 (ibudilast) for treatment of Type 1 - Early Infantile Krabbe disease.
- Read more about FDA outlines cybersecurity recommendations for medical device manufacturers
The US Food and Drug Administration (FDA) issued a draft guidance outlining important steps medical device manufacturers should take to continually address cybersecurity risks to keep patients safe and better protect the public health.
- Read more about Titan Pharmaceuticals and Braeburn Pharmaceuticals announce Fda advisory committee recommends approval of probuphine
Titan Pharmaceuticals, Inc. and partner Braeburn Pharmaceuticals announced that the Psychopharmacologic Drugs Advisory Committee (PDAC) of the U.S. Food and Drug Administration (FDA) voted 12 to 5 in favor of approving Probuphine, the first long-acting, subdermal buprenorphine implant for the maintenance treatment of opioid addiction, in stable patients receiving 8mg or less per day of buprenorphine. The Committee’s vote followed presentation and discussion of data regarding Probuphine’s efficacy, safety, and risk-benefit profile. The New Drug Application (NDA) for Probuphine was resubmitted to the FDA in August 2015, and accepted by the FDA in September 2015. A target agency action date has been set for February 27, 2016.
- Read more about Five Prime Therapeutics Receives FDA Orphan Drug Designation for FPA008 in PVNS
Five Prime Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for FPA008 for the treatment of Pigmented Villonodular Synovitis (PVNS), a locally aggressive tumor of the synovium.
- Read more about FDA clears Olympus TJF-Q180V duodenoscope with design modifications to reduce infection risk
The US Food and Drug Administration cleared the Olympus TJF-Q180V duodenoscope with modifications to the device’s design and labeling intended to help reduce the risk of bacterial infections. Olympus will voluntarily recall its original model currently being used in health care facilities and make the needed repair as quickly as possible.
- Read more about Heron Therapeutics Notified by FDA
Heron Therapeutics, Inc., announced that the U.S. Food and Drug Administration (FDA) has informed the Company that it has not yet completed its review of the New Drug Application (NDA) of SUSTOL® (granisetron) Injection,extended release and would not be taking action by the Prescription Drug User Fee Act (PDUFA) goal date of January 17, 2016 and anticipates taking action in late February 2016.
- Read more about Nivalis Therapeutics Announces FDA Orphan Drug Designation for N91115 in Cystic Fibrosis
Nivalis Therapeutics, Inc., a clinical stage pharmaceutical company focused on developing innovative solutions for people with cystic fibrosis (“CF”), announced the U.S. Food and Drug Administration ("FDA") has granted Orphan Drug Designation to the Company's lead investigational drug, N91115, a novel stabilizer of the cystic fibrosis transmembrane conductance regulator (CFTR) protein.
- Read more about Gilead submits NDA to FDA for Chronic Hepatitis B drug
Gilead Sciences, Inc. announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tenofovir alafenamide (TAF) 25 mg, an investigational, once-daily treatment for adults with chronic hepatitis B virus (HBV) infection.
- Read more about Pluristem Receives U.S. FDA Clearance to Initiate Clinical Trial of PLX-R18
Pluristem Therapeutics Inc, a leading developer of placenta-based cell therapy products, announced that the U.S. Food and Drug Administration (FDA) cleared the Company’s Investigational New Drug (IND) application to begin its Phase I trial of PLX-R18 cells to treat incomplete hematopoietic recovery following Hematopoietic Cell Transplantation (HCT). The clinical trial is expected to begin in the first half of 2016.
- Read more about Immune Design Receives Orphan Drug Designation From the USFDA for Complementary Components of CMB305
Immune Design, a clinical-stage immunotherapy company focused on oncology, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for LV305 and G305 for the treatment of soft tissue sarcoma. LV305 and G305 are the complementary agents that comprise CMB305, Immune Design's "prime boost" cancer immunotherapy product candidate.