EIGER BIOPHARMACEUTICALS, INC.: Announces FDA Breakthrough Therapy Designation for Peginterferon Lambda for Treatment of Hepatitis Delta Virus Infection
Fourth Eiger Program Granted Breakthrough Therapy Designation
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ASTELLAS PHARMA, INC.: U.S. FDA Grants XTANDI® (enzalutamide) Application Priority Review for the Treatment of Men with Metastatic Hormone-Sensitive Prostate Cancer
XTANDI Supplemental New Drug Application (sNDA) Seeks to Add an Indication for Men with Prostate Cancer that Has Spread but Is Sensitive to Hormone Therapy
MCKESSON: ROZLYTREK™ (entrectinib), FDA Approved for Hard-to-Treat NTRK Fusion-Positive Tumors, Available at Biologics by McKesson
Biologics by McKesson, an independent specialty pharmacy for oncology and other rare and complex therapeutic areas, was selected by Genentech as a specialty pharmacy provider for ROZLYTREK™ (entrectinib) for the treatment of hard-to-treat and rare NTRK fusion-positive tumor
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VERTEX PHARMACEUTICALS: FDA Accepts New Drug Application for VX-445 (Elexacaftor), Tezacaftor and Ivacaftor Combination Treatment
FDA Grants Priority Review of the application and sets a PDUFA target action date of March 19, 2020
CERECOR: Receives Fast Track Designation from FDA for CERC-802 for the Treatment of Mannose-Phosphate Isomerase Deficiency
Cerecor Inc. (NASDAQ: CERC), a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare and orphan diseases in pediatrics and neurology, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for CERC-802, an ultra-pure, oral formulation of D-mannose currently in development for the treatment of Mannose-Phosphate Isomerase Deficiency, also known as MPI-CDG or CDG-1b.
FDA Update: June facility inspection results
The U.S. Food and Drug Administration inspects numerous facilities around the nation to ensure that they comply with current rules governing FDA-regulated products.
SAREPTA THERAPEUTICS: Receives Complete Response Letter from the US Food and Drug Administration for Golodirsen New Drug Application
Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced it had received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) seeking accelerated approval of golodirsen injection for the treatment of Duchenne muscular dystrophy (DMD) in patients with a confirmed mutation amenable to exon 53 skipping.
Islaroxime receives FDA Fast Track Designation
The U.S. Food and Drug Administration (FDA) granted its Fast Track Designation to islaroxime, which is used for the treatment of acute heart failure. Islaroxime was developed by Windtree Therapeutics Inc., a biotechnology and medical device company.
Eylea Injection Prefilled Syringe approved by FDA
The Eylea Injection Prefilled Syringe received the Chemistry, Manufacturing and Controls Prior-Approval Supplement by the Food and Drug Administration (FDA), according to a statement released by Regeneron Pharmaceuticals Inc.
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US WORLDMEDS: FDA Approves US WorldMeds' MYOBLOC® (rimabotulinumtoxinB) Injection for Chronic Sialorrhea
MYOBLOC is the only approved botulinum toxin for chronic sialorrhea that provides significant results in as early as one week(1),(2)
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).
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.
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.
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).
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.
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
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.
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.
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.
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.