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13:03 EST 12th December 2017 | BioPortfolio

Brexit health risk: UK must negotiate role in EU drug safety monitoring says industry

Identifying dangerous medicines will take months longer than at present if the UK cannot negotiate continued involvement in EU drug safety and health monitoring say industry groups.

STAT Plus: Pharmalittle: Regulation of OTC drugs is a mess; another Senate hearing on drug prices

The U.K.'s National Institute for Health and Care Excellence is not recommending the Mysimba diet drug.

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The FDA Accepts Eli Lilly's BLA For Migraine Drug Review

NewsGalcanezumab, for the prevention of migraine in adults, is the first of three investigational, non-opioid treatments in Lilly's pain portfolio.

The FDA Accepts Eli Lilly's BLA For Migraine Drug Review

NewsGalcanezumab, for the prevention of migraine in adults, is the first of three investigational, non-opioid treatments in Lilly's pain portfolio.

FDA Approves Admelog, The First Short-Acting 'Follow-on' Insulin Product To Treat Diabetes

NewsAdmelog is a short-acting insulin product indicated to improve control in blood sugar levels in adults and pediatric patients aged 3 years and older with type 1 diabetes mellitus and adults with type 2 diabetes mellitus.

Boston Scientific Receives U.S. FDA Approval for the Vercise™ Deep Brain Stimulation System

Platform Offers Physicians Advanced Technology to Treat Symptoms of Parkinson's disease MARLBOROUGH, Mass., Dec. 11, 2017 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for the Vercise™ Deep Brain Stimulation (DBS) System. DBS is used to treat the symptoms of Parkinson's disease (PD), a d...

STAT Plus: Three more drug makers allegedly used nurses to promote medicines

Three more drug makers allegedly relied on schemes in which nurses were used to illegally promote its diabetes medicines to physicians, according to recently unsealed lawsuits. The documents describe how…

FDA approves short-acting insulin Admelog for type 2 diabetes

The FDA on Monday announced the approval of Admelog, the first follow-on short-acting insulin indicated to improve blood glucose control in adult and pediatric patients with type 1 or type 2 diabetes, according to an agency press release.The approval of follow-on insulin lispro (Admelog, Sanofi) was achieved through an abbreviated approval pathway under the Food, Drug and Cosmetic Act. A new drug ...

FDA Approves New Human Insulin Product to Treat Diabetes

The short-acting insulin lispro injection has been granted final approval from the FDA to treat adults with type 2 diabetes and adults and children...

Some prescription drugs are cheaper without insurance

Body:  Consumers are increasingly paying more for drugs through health insurance than they would if they found the best deal on their own, according to an article published jointly by The New York Times and ProPublica.This counterintuitive situation occurs in up to 10 percent of drug transactions, one expert said.“There’s no chance a consumer can figure it out without help,” Michael Rae...

Immune-Boosting Drug Cocktail Slows Kidney Cancer

Combining Roche's Tecentriq immunotherapy with its older drug Avastin for the initial treatment of advanced kidney cancer reduced the risk of the disease worsening or of death in certain patients, the Swiss drugmaker said on Monday. The trial tested the combination against the current standard of care, Pfizer's Sutent, in patients with inoperable, locally advanced or metastatic renal cell ...

FDA Drug Safety Communication: FDA cautions about using testosterone products for low testosterone due to aging; requires labeling change to inform of possible increased risk of heart attack and stroke with use

[03-03-2015] The U.S. Food and Drug Administration (FDA) cautions that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions.

FDA Drug Safety Communication: FDA updates label for stop smoking drug Chantix (varenicline) to include potential alcohol interaction, rare risk of seizures, and studies of side effects on mood, behavior, or thinking

[03-09-2015] The U.S. Food and Drug Administration (FDA) is warning that the prescription smoking cessation medicine Chantix (varenicline) can change the way people react to alcohol.

Janssen Submits sNDA For Two New Xarelto Vascular Indications

NewsThe application seeks approval of the Xarelto vascular dose (2.5mg BID) to reduce the risk of major cardiovascular events in patients with chronic coronary and/or peripheral artery disease, and to reduce the risk of acute limb ischemia.

Drug Companies Sue To Block California Drug Price Law

NewsPharmaceutical companies on Friday sued to block a new California law that would require them to give advance notice before big price increases. The law was approved this year in response to consumer outrage over some high prescription costs.

New Drug Could Stall Deadly Symptoms Of Rattlesnake Bite

NewsAs soon as a rattlesnake sinks its fangs into a victim, it's a race against time to get to a hospital for anti-venom treatment. One University of Arizona doctor hopes to buy people more time before they get to the hospital.

New Antibody-Drug Conjugate Offers Hope to Hard-to-Treat Cancer Patients

ADC Therapeutics has tested its antibody-drug conjugate technology in drug-resistant cancers, yielding encouraging results. Swiss biotech ADC Therapeutics is one of our top biotechs of the year after it brought in a massive $200M (€170M) fundraising round. The company develops antibody-drug conjugates (ADCs) ... This awesome article New Antibody-Drug Conjugate Offers Hope to Hard-to-Treat Can...

Lia Diagnostics gains FDA approval for flushable, biodegradable pregnancy test

Michael JohnsenLia made its global debut on Dec. 4, 2017 at TechCrunch Disrupt Berlin's Startup Battlefield and took home the grand prize. read more

Alnylam: FDA Grants Request To Amend Orphan Drug Designation For Patisiran

Alnylam Pharmaceuticals Inc. (ALNY) said that the U.S. Food and Drug Administration has granted a request to amend the orphan drug designation for patisiran to the treatment of transthyretin-mediated amyloidosis (ATTR amyloidosis). This is an expansion to patisiran's prior designation which was for the treatment of familial amyloidotic polyneuropathy.

FDA Approves Investigational Device Exemption for SetPoint Bioelectronic Therapy Clinical Study in Rheumatoid Arthritis

SetPoint Medical, a clinical-stage biomedical technology company developing an implantable bioelectronic medicine therapy for chronic inflammatory diseases, has received Investigational Device Exemption (IDE) approval from the U.S. Food & Drug Administration (FDA) to initiate a pilot trial in the U.S. for patients with drug refractory rheumatoid arthri...

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Could this British Biotech’s Drug Help to Bring Down COPD Hospitalizations?

Mereo BioPharma’s drug, BCT-197, more than halved the number of hospitalizations of chronic obstructive pulmonary disease patients during a Phase II trial. Mereo BioPharma develops therapies for patients with rare diseases. Today, it has announced that BCT-197, or acumapimod, improved lung function and reduced ... This awesome article Could this British Biotech’s Drug Help to Bring Down CO...

Lilly Drug Misses Secondary Endpoint In Gastric Cancer Study

NewsThe trial met its primary endpoint of progression-free survival in first-line advanced gastric cancer, but did not improve overall survival, a secondary endpoint. The company does not intend to seek regulatory approval for that indication based on the study results.

Record low number of FDA warnings to drugmakers that lie in ads

In the midst of a national opioid crisis, the federal agency that monitors drug ads has issued a record low number of warning letters to pharmaceutical companies caught lying about their products. The Food and Drug Administration has sent a mere three letters to drugmakers busted for overhyping their medications to unknowing consumers, the lowest ever since the agency's historic decision to ea...

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