TRICIDA: Announces Submission of New Drug Application for Veverimer for the Treatment of Metabolic Acidosis in Patients with Chronic Kidney Disease
NDA Submitted under the FDA’s Accelerated Approval Program
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Sen. Durbin calls for more e-cigarette product regulation from FDA
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.
RA PHARMACEUTICALS: Receives Orphan Drug Designation from the U.S. FDA for Zilucoplan for the Treatment of Myasthenia Gravis
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.
PUMA BIOTECHNOLOGY: FDA Grants Orphan Drug Designation to Puma Biotechnology’s NERLYNX® for the Treatment of Breast Cancer Patients with Brain Metastases
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.
INOTREM: Announces Fast Track Designation Granted by U.S. FDA to Nangibotide Development Program for the Treatment of Septic Shock
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.
U.S. FOOD AND DRUG ADMINISTRATION: FDA sends warning to company for selling unapproved umbilical cord blood and umbilical cord products that may put patients at risk; continues to warn patients of the risk of unapproved stem cell therapy
Stemell sold stem cell products without required FDA approval
BIOMED: Impella® SmartAssist Platform Launches at ESC, Designed to Further Improve Patient Outcomes
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.
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FRESENIUS KABI: Introduces Phenylephrine Hydrochloride Injection, USP
Generic Equivalent to Vazculep® is Newest Addition to Broad Portfolio of Anesthesia and Analgesia Products
CARSGEN THERAPEUTICS: Receives US FDA Orphan Drug Designation For Fully Human Anti-BCMA (B Cell Maturation Antigen) Autologous Chimeric Antigen Receptor (CAR) T Cells For The Treatment Of Multiple Myeloma
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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Doctors see good things with new scoliosis treatment recently approved by FDA
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.
Drawbridge Health's new blood collection device receives 510(k) clearance
Drawbridge Health received 510(k) clearance from the Food and Drug Administration for its’ OneDraw A1C Test System on Aug. 22.
Super antioxidant Ergothioneine achieves GRAS status
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.
FDA approves new treatment for scoliosis
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.
AKORN: Receives FDA Approval for Azelastine Hydrochloride Nasal Spray, 0.15%
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.
U.S. FOOD AND DRUG ADMINISTRATION: FDA recommends health care facilities and manufacturers begin transitioning to duodenoscopes with disposable components to reduce risk of patient infection
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
FDA plans 17 public meetings in September
Seventeen public meetings, conferences or workshops sponsored by the U.S. Food and Drug Administration have been scheduled for September, the FDA reported.
EMALEX BIOSCIENCES: Receives FDA Fast Track Designation for Ecopipam for the Treatment of Patients with Tourette Syndrome
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).
KYOWA KIRIN CO., LTD.: Kyowa Kirin Announces FDA Approval of NOURIANZ™ (istradefylline) for Use in Parkinson’s Disease
First and only Adenosine A2A receptor antagonist for use in Parkinson’s Disease in the U.S.
U.S. FOOD AND DRUG ADMINISTRATION: Statement calling on all sectors of the papaya industry to improve practices to better protect consumers
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.
ELI LILLY & COMPANY: Lilly Receives U.S. FDA Approval for Taltz® (ixekizumab) for the Treatment of Active Ankylosing Spondylitis (Radiographic Axial Spondyloarthritis)
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).