iclaprim Treatment for Skin and Structure Infection Motif Bio Receives Complete Response Letter From The FDA NEW YORK, Feb. 14, 2019 (GLOBE NEWSWIRE) — Motif Bio plc (AIM/NASDAQ: MTFB), a clinical-stage biopharmaceutical company specialising in developing novel antibiotics, announced today that the Company has received a Complete Response Letter (CRL) from the U.S. Food & […]Continue Reading ...
NEWARK, Calif., Feb. 15, 2019 (GLOBE NEWSWIRE) — CymaBay Therapeutics, Inc. (NASDAQ: CBAY), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for seladelpar for the treatment of early stage primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adult patients with an inadequate response to UDCA, […]Continue Reading ...
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: FDA Panel Backs Ketamine-like Drug for Depression An expert panel for the U.S. Food and Drug Administration has endorsed a drug for major depressive disorder that is a close relative to the club drug ketamine, or “Special K.” […]Continue Reading ...
pexidartinib Treatment for Tenosynovial Giant Cell Tumor FDA Grants Priority Review for Daiichi Sankyo’s New Drug Application for CSF1R Inhibitor Pexidartinib for Treatment of Patients with TGCT, a Rare, Debilitating Tumor Tokyo, Munich and Basking Ridge, NJ – February 5, 2019 – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that the U.S. Food and […]Continue Reading ...
The US Centers for Disease Control and Prevention (CDC) reported this week that in 2018 there are around 4.9 million American teenagers who are using tobacco in the form of cigarettes, e-cigarettes, cigars and hookahs. This is around 1.5 million more than the previous year they add in the report. Smoking cigarettes has declined but […]Continue Reading ...
Treatment for Pain Pain Therapeutics Announces Feedback from Recent Meeting With FDA on Remoxy AUSTIN, Texas, Feb. 05, 2019 (GLOBE NEWSWIRE) — Pain Therapeutics, Inc. (Nasdaq: PTIE), a clinical-stage drug development company, today announced feedback from a meeting held January 31, 2019 with the U.S. Food and Drug Administration (FDA) regarding the drug candidate, Remoxy […]Continue Reading ...
Hologic, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted clearance for its Aptima® Mycoplasma genitalium assay, the first and only FDA-cleared test to detect this under-recognized but increasingly common sexually transmitted infection (STI). This newest Aptima assay joins a growing suite of market-leading tests offered by Hologic to help combat […]Continue Reading ...
Treatment for Transthyretin Familial Amyloid Polyneuropathy; Transthyretin Cardiomyopathy US FDA Accepts Regulatory Submissions for Review of Tafamidis to Treat Transthyretin Amyloid Cardiomyopathy January 14, 2019 – Pfizer Inc. (NYSE: PFE) announced today that the US Food and Drug Administration (FDA) accepted for filing the company’s New Drug Applications (NDAs) for tafamidis for the treatment of […]Continue Reading ...
entrectinib Treatment for Solid Tumors FDA Grants Priority Review to Genentech’s Personalized Medicine Entrectinib South San Francisco, CA — February 18, 2019 — Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Applications (NDAs) and granted […]Continue Reading ...
Today, the U.S. Food and Drug Administration issued a warning letter to Mark Berman, M.D., of Beverly Hills, California, for illegally marketing an unapproved implantable device, the Pocket Protector, that Dr. Berman claims can prevent and treat a complication of breast implants known as capsular contracture, or tightening of scar tissue. The warning letter also […]Continue Reading ...
Basel, Switzerland, February 13, 2019 – Novartis announced today that the US Food and Drug Administration (FDA) has approved Egaten (triclabendazole) for the treatment of fascioliasis in patients six years of age and older. This makes Egaten the only FDA-approved drug for people with this disease and is expected to facilitate broader access to this […]Continue Reading ...
The U.S. Food and Drug Administration today posted 12 warning letters and 5 online advisory letters issued to foreign and domestic companies that are illegally selling more than 58 products, many that are sold as dietary supplements, which are unapproved new drugs and/or misbranded drugs that claim to prevent, treat or cure Alzheimer’s disease and […]Continue Reading ...
The U.S. Food and Drug Administration today permitted marketing of a new test to aid in the diagnosis of a sexually-transmitted infection (STI) called Mycoplasma genitalium (M. gen.). This is the first test authorized by the FDA to test for the M. gen. bacterium, which is associated with inflammation of the urethra (non-gonococcal urethritis) in […]Continue Reading ...
Home News New Drugs FDA Approves Ontruzant (trastuzumab-dttb), a Biosimilar to Herceptin January 18, 2019 — FDA today approved Ontruzant (trastuzumab-dttb), a biosimilar to U.S.-licensed Herceptin (trastuzumab). A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-FDA approved biological product, known as a […]Continue Reading ...
Nabriva Therapeutics Announces Acceptance of the New Drug Application for Intravenous Contepo to Treat Complicated Urinary Tract Infections by FDA DUBLIN, Ireland, Jan. 04, 2019 (GLOBE NEWSWIRE) — Nabriva Therapeutics plc (NASDAQ: NBRV), a clinical-stage biopharmaceutical company engaged in the research and development of innovative anti-infective agents to treat serious infections, announced that the U.S. […]Continue Reading ...
- The United States records highest drug overdose death rates
- Phase 1 data reinforce safety profile of new drug for treating Duchenne muscular dystrophy
- Vitamin D supplementation less effective in the presence of obesity, shows study
- Sarepta Announces FDA Acceptance of Golodirsen (SRP-4053) New Drug Application for Patients with Duchenne Muscular Dystrophy Amenable to Skipping Exon 53
- An institutional effort to reduce the amount of opioids prescribed following lumbar surgery
- Failure to take statins leads to higher mortality rates | News Center
- Novel preclinical model mimics persistent interneuron loss seen in preterm infants
- Global health burden of glaucoma has increased, study reveals
- A holistic approach key to minimize treatment complexity in patients with interstitial lung disease
- 1 in 10 middle-aged Chinese adults are at high risk for heart disease, finds study
- More than half a million breast cancer patient’s lives saved by improvements in treatment
- Study finds no evidence that tougher policies prevent teenage cannabis use
- New blood test detects genetic disorders in fetuses
- Lower Self-Perception Observed in Children With Amblyopia
- Up to 15 percent of children have sleep apnea, yet 90 percent go undiagnosed
- Rare pulmonary defect prompts parents’ nationwide search for answers | News Center
- Lesbian and bisexual women at greater risk of being overweight, study finds
- UQ research may explain why vitamin D is essential for brain health
- Heart Attacks Rising Among Younger Women
- How your smartphone is affecting your relationship