Murray Hill, New Jersey-based surgical product producer and marketer C. R. Bard recently obtained premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) for its Lutonix 035 drug coated balloon PTA catheter (DCB). Read More »
The U.S. Food and Drug Administration advises consumers and health care professionals to not use any liquid drug or dietary supplement products manufactured by PharmaTech LLC of Davie, Florida, and labeled by Rugby Laboratories, Major Pharmaceuticals and Leader Brands. Read More »
Moleculin Biotech Inc. recently released comments regarding recent FDA approvals for new drugs that treat acute myeloid leukemia. Read More »
Mitsubishi Tanabe Pharma America Inc. of New Jersey has reported that Radicava (edaravone), an intravenous therapy for adults with amyotrophic lateral sclerosis (ALS), is now available in the U.S. Read More »
The first eight-week medication cycle for chronic hepatitis C virus (HCV) recently earned approval from the U.S. Food and Drug Administration (FDA) in the form of Mavyret (glecaprevir and pibrentasvir), shortening treatment duration by one-third. Read More »
The U.S. Food and Drug Administration is creating new regulation on tobacco and nicotine to reduce diseases and death brought on by tobacco use. Read More »
To better tend babies in the nation’s neonatal intensive care units, the first magnetic resonance imaging (MRI) device designed for newborns recently garnered U.S. Food and Drug Administration approval following thorough safety confirmation. Read More »
Pharmaceutical Care Management Association (PCMA) President and CEO Mark Merritt has written directly to U.S. Food and Drug Administration Commissioner Scott Gottlieb to offer the association’s concise solution for fast-tracking “common-sense” improvements to the nation’s opioid abuse policy. Read More »
PRN1008 — acting as a reversible covalent Bruton’s Tyrosine Kinase (BTK) inhibitor — has attained orphan drug designation by the U.S. Food and Drug Administration (FDA) for treating pemphigus vulgaris, its producer Principia Biopharma Inc. announced recently. Read More »
Biohaven Pharmaceutical Holding Co. has been granted Fast Track Designation for its product candidate Trigriluzole by the FDA. Read More »
OncoSec Medical Inc.'s pIL-12 drug, also known as tavokinogene telsaplasmid, has been given an Orphan Drug Designation by the U.S. Food and Drug Administration. Read More »
After documenting recent product abuse, the U.S. Food and Drug Administration asked Endo Pharmaceuticals to voluntarily remove its reformulated Opana ER (oxymorphone hydrochloride) opioid medication from circulation, stating that risks may now outnumber benefits. Read More »
A pioneering prototype blending a mood stabilizer with technology is on the radar for two companies determined to develop a combination drug/device that, if approved by the FDA, could potentially address serious mental health challenges. Read More »
Panacea Pharmaceuticals has filed a U.S. patent application for Immune System Enhancing Immunotherapy for the treatment of cancer. Read More »
Otsuka Pharmaceutical has entered into a licensing agreement that gives it exclusive rights to develop and commercialize Teva Pharmaceutical Industries' migraine prevention drug fremanezumab in Japan. Read More »
DrFirst, an electronic prescribing company, has acquired VisibilityRx, a provider of clinical trial recruitment services to life sciences, clinical research organizations and pharmacies. Read More »
Personal Genome Diagnostics Inc. has received a National Cancer Institute contract to develop a novel diagnostic for helping identify patients who are most likely to benefit from cancer drugs called checkpoint inhibitors. Read More »
The U.S. Food and Drug Administration (FDA) has permitted the use of subcutaneous Actemra (tocilizumab) to assist adults who are receiving treatment for giant cell arteritis. Read More »
The drug Kalydeco was recently approved to treat additional case of gene mutations in cystic fibrosis patients, the U.S. Food and Drug Administration reported on May 17 in a press release. Read More »
The FDA recently approved Abon Pharmaceuticals' Abbreviated New Drug Application for its Clofarabine Injection as a treatment for pediatric patients who suffer from relapsed or refractory acute lymphoblastic leukemia, a deadly cancer disease. Read More »
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