Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved Taltz® (ixekizumab) injection 80 mg/mL for the treatment of adults with active ankylosing spondylitis (AS), also known as radiographic axial spondyloarthritis (r-axSpA).
The U.S. Food and Drug Administration works tirelessly to ensure that foods available to consumers, whether they are produced domestically or abroad, meet the FDA’s food safety requirements and that we are using all available tools to ensure compliance.
First and only Adenosine A2A receptor antagonist for use in Parkinson’s Disease in the U.S.
Emalex Biosciences, Inc. (Emalex), a biopharmaceutical company developing innovative therapies for patients with neurological and psychiatric conditions, announced today that it has received Fast Track designation for its investigational product, ecopipam, from the U.S. Food and Drug Administration (FDA) for the treatment of patients with Tourette Syndrome (TS).
Seventeen public meetings, conferences or workshops sponsored by the U.S. Food and Drug Administration have been scheduled for September, the FDA reported.
In continued efforts to protect patient safety, FDA orders new postmarket studies for manufacturers, requests real-world contamination rates in duodenoscope labeling and warns about certain test strips illegally marketed to assess duodenoscope cleanliness
Akorn, Inc. (Nasdaq: AKRX), a leading specialty generic pharmaceutical company, announced that it received a new Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for Azelastine Hydrochloride Nasal Spray, 0.15%. The product is manufactured at Akorn’s Amityville, New York manufacturing facility.
The U.S. Food and Drug Administration approved an innovative treatment for scoliosis last week and it happens to have a fancy nickname. It’s called The Tether and it provides a fusion-less alternative for young patients requiring surgery.
The super antioxidant called ergothioneine or ErgoActive by ingredient supplier and manufacturer Blue California has achieved Generally Recognized as Safe (GRAS) status from the Food and Drug Administration (FDA) under its intended conditions of use.
Drawbridge Health received 510(k) clearance from the Food and Drug Administration for its’ OneDraw A1C Test System on Aug. 22.
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A doctor based at Johns Hopkins in Baltimore sees the new treatment for scoliosis recently approved by the U.S. Food and Drug Administration as a viable option for young patients.
CARsgen Therapeutics Inc., a clinical-stage biopharmaceutical company today announced the United States Food and Drug Administration (FDA) has granted orphan drug designation to its investigational CAR-T cell therapy fully human anti-BCMA (B Cell Maturation Antigen) autologous chimeric antigen receptor (CAR) T Cells (ct053) for the treatment of multiple myeloma.
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Generic Equivalent to Vazculep® is Newest Addition to Broad Portfolio of Anesthesia and Analgesia Products
Abiomed (NASDAQ: ABMD) announces that the Impella CP® with SmartAssist technology, which is designed to improve patient outcomes with advanced algorithms and simplified patient management, will be commercially available in Europe beginning at the European Society of Cardiology (ESC) Congress 2019 through a controlled roll out process at select sites.
Stemell sold stem cell products without required FDA approval
Inotrem S.A., a biotechnology company specialized in immunotherapy for acute and chronic inflammatory syndromes, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to nangibotide development program for the treatment of septic shock.
Puma Biotechnology, Inc. (Nasdaq: PBYI) announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to NERLYNX® (neratinib) for the treatment of breast cancer patients with brain metastases.
Ra Pharmaceuticals, Inc. (Nasdaq:RARX) today announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to zilucoplan for the treatment of myasthenia gravis.
Following the death of an Illinois citizen who suffered from respiratory illness after vaping, Sen. Dick Durbin (D-IL) sent a letter to the Food and Drug Administration and the Center for Tobacco Products demanding that they remove e-cigarettes and related vaping products off of the market.
The Food and Drug Administration gave the go-ahead last week to accept Seelos Therapeutics’ application for a new drug to combat Sanfilippo syndrome, a rare genetic defect.