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- 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.
- Read more about MST get FDA Clearance for Follow Me Image-Guided Software
MST–Medical Surgery Technologies Ltd., a leader in the field of advanced image-based robotic technology, announced that the U.S. Food and Drug Administration (FDA) has cleared the Follow Me™ software designed for minimally invasive robotic surgery. Follow Me™ is an advanced function of MST’s AutoLap®, an image-guided laparoscope positioning system. Powered by MST’s image-based intelligence technology, AutoLap® enables full and natural control of the surgical procedure with minimal user interaction.
- Read more about Stealth BioTherapeutics Receives FDA Fast Track Designation for Rare Disease Indication
Stealth BioTherapeutics (Stealth), a biopharmaceutical company developing drug candidates for treating mitochondrial dysfunction, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for MTP-131 (also known as Bendavia) for the treatment of primary mitochondrial myopathy, characterized by muscle weakness in patients with genetic mitochondrial diseases. MTP-131 is currently being studied for the treatment of primary mitochondrial myopathy in its MMPOWER trial, with results expected midyear.
- Read more about FDA approves Integra Omnigraft Dermal Regeneration Matrix to treat diabetic foot ulcers
The U.S. Food and Drug Administration approved a new indication for the Integra Omnigraft Dermal Regeneration Matrix (Omnigraft) to treat certain diabetic foot ulcers. The matrix device, which is made of silicone, cow collagen, and shark cartilage, is placed over the ulcer and provides an environment for new skin and tissue to regenerate and heal the wound.
- Read more about US Marshals seize dietary supplements containing kratom
The U.S. Food and Drug Administration announced that U.S. Marshals, at the agency’s request, seized nearly 90,000 bottles of dietary supplements labeled as containing kratom. The product, manufactured for and held by Dordoniz Natural Products LLC, located in South Beloit, Illinois, is marketed under the brand name RelaKzpro and worth more than $400,000.
- Read more about LivaNova PLC Provides Update on FDA Warning Letter
LivaNova PLC received a Warning Letter dated December 29, 2015, from the United States Food and Drug Administration (“FDA”) alleging certain violations of FDA regulations applicable to medical device manufacturers at its Munich, Germany and Arvada, Colorado facilities.
- Read more about MiMedx Receives Certificate From FDA Allowing The Export Of MiMedx Allografts
MiMedx Group, Inc., the leading regenerative medicine company utilizing human amniotic tissue and patent-protected processes to develop and market advanced products and therapies for the Wound Care, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic, and Dental sectors of healthcare, announced that it has recently posted an updated "Certificate to Foreign Government" on its website that describes all of the MiMedx sheet form allografts and the Food and Drug Administration FDA's certification that the listed products are HCT/P's.