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FDA grants accelerated approval to Praxbind (idarucizumab)

The U.S. Food and Drug Administration today granted accelerated approval to Praxbind (idarucizumab) for use in patients who are taking the anticoagulant Pradaxa (dabigatran) during emergency situations when there is a need to reverse Pradaxa's blood-thinning effects.

19 Oct 2015

Boehringer Ingelheim announces FDA approval of Praxbind (idarucizumab)

Boehringer Ingelheim Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration granted approval of Praxbind (idarucizumab). PRAXBIND is indicated for patients treated with Pradaxa (dabigatran etexilate mesylate), when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding.

16 Oct 2015

Loyola partners with Cook County Sheriff's Department to hold Medication Take-Back Day on October 20

Loyola University Health System will partner with the Cook County Sheriff's Department to hold a Medication Take-Back Day on Tuesday, October 20, 2015 from 9 am to 3 pm at the Loyola Outpatient Center lobby located at 2160 S. First Ave. in Maywood.

15 Oct 2015

Boehringer Ingelheim, Lilly announce availability of Synjardy tablets in U.S. pharmacies

Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company announced that Synjardy (empagliflozin/metformin hydrochloride) tablets are now available by prescription in pharmacies across the United States.

14 Oct 2015

Penn researchers show that canine X-linked retinitis pigmentosa can be cured over the long term

Three years ago, a team from the University of Pennsylvania announced that they had cured X-linked retinitis pigmentosa, a blinding retinal disease, in dogs. Now they've shown that they can cure the canine disease over the long term, even when the treatment is given after half or more of the affected photoreceptor cells have been destroyed.

13 Oct 2015

CVMA applauds Governor Brown for signing landmark antibiotics bill

The California Veterinary Medical Association (CVMA) applauds Governor Jerry Brown for signing SB 27 (Hill) into law. This bill sets aggressive, groundbreaking standards for antimicrobial drug use in California livestock and will positively impact antibiotic resistance in both humans and animals.

13 Oct 2015

FDA orders three duodenoscope manufacturers in the U.S. to conduct postmarket surveillance studies

The U.S. Food and Drug Administration today ordered the three manufacturers of duodenoscopes marketed in the U.S. to conduct postmarket surveillance studies to better understand how the devices are reprocessed in real-world settings.

12 Oct 2015

FDA permits marketing of first CSF nucleic acid-based test for detection of multiple pathogens

The U.S. Food and Drug Administration today allowed marketing of the first cerebrospinal fluid (CSF) nucleic acid-based test for simultaneous detection of multiple pathogens that can cause central nervous system infections.

12 Oct 2015

Federal judge grants permanent injunction against South Dakota medical laser manufacturer

A federal judge in the U.S. District Court for the District of South Dakota yesterday granted the U.S. Food and Drug Administration a permanent injunction against 2035 Inc. and Robert "Larry" Lytle, doing business as QLasers PMA and 2035 PMA.

12 Oct 2015

FDA approves Opdivo to treat patients with advanced non-small cell lung cancer

The U.S. Food and Drug Administration today approved Opdivo (nivolumab) to treat patients with advanced (metastatic) non-small cell lung cancer whose disease progressed during or after platinum-based chemotherapy.

11 Oct 2015

FDA awards research grants to boost product development for patients with rare diseases

The U.S. Food and Drug Administration today announced it has awarded 18 new research grants totaling more than $19 million to boost the development of products for patients with rare diseases, which affect the lives of nearly 30 million Americans.

11 Oct 2015

FDA takes major step to put greater emphasis on the prevention of foodborne illness

The U.S. Food and Drug Administration today took one of the most significant steps in decades to prevent foodborne illness by finalizing the first two of seven major rules under the bipartisan FDA Food Safety Modernization Act (FSMA).

9 Oct 2015

FDA allows marketing of new EarLens Contact Hearing Device

The U.S. Food and Drug Administration today allowed marketing of a new hearing aid that uses a laser diode and direct vibration of the eardrum to amplify sound. The combination of laser light pulses and a custom-fit device component that comes in direct contact with the eardrum is designed to use the patient's own eardrum as a speaker and enables amplification over a wider range of frequencies for some hearing impaired persons.

9 Oct 2015

FDA approves Lonsurf drug for patients with advanced form of colorectal cancer

The U.S. Food and Drug Administration today approved Lonsurf (a pill that combines two drugs, trifluridine and tipiracil) for patients with an advanced form of colorectal cancer who are no longer responding to other therapies.

9 Oct 2015

FDA approves expanded indication for Optune device for brain cancer patients

The U.S. Food and Drug Administration today approved an expanded indication for the Optune device to treat patients with newly-diagnosed glioblastoma multiforme (GBM), an aggressive form of brain cancer.

9 Oct 2015

FDA announces launch of new education campaign to prevent, reduce tobacco use among hip-hop youth

The U.S. Food and Drug Administration today announced the launch of a national public education campaign to prevent and reduce tobacco use among multicultural youth who identify with the hip-hop peer crowd ‒ a group that is often hard to reach and frequently exposed to pro-tobacco images and messages. While multicultural teens identify with more than one group, the FDA is focusing on those in the hip-hop peer crowd because research estimates that they are more likely to use tobacco than other youth.

9 Oct 2015

Xuriden (uridine triacetate) now approved for patients with hereditary orotic aciduria

Today, the U.S. Food and Drug Administration approved Xuriden (uridine triacetate), the first FDA-approved treatment for patients with hereditary orotic aciduria. Hereditary orotic aciduria is a rare metabolic disorder, which has been reported in approximately 20 patients worldwide.

9 Oct 2015

FDA approves Promacta to treat pediatric patients with chronic immune thrombocytopenic purpura

The U.S. Food and Drug Administration today approved Promacta (eltrombopag) to treat low blood platelet count in pediatric patients – ages one year and older – with a rare blood disorder called chronic immune thrombocytopenic purpura (ITP). Promacta can be used in these children when they have not achieved an appropriate response using other ITP medicines or surgery to remove the spleen.

9 Oct 2015

Aristada (aripiprazole lauroxil) extended release injection approved to treat adults with schizophrenia

On October 5, the U.S. Food and Drug Administration approved Aristada (aripiprazole lauroxil) extended release injection to treat adults with schizophrenia. Aristada is administered by a health care professional every four to six weeks using an injection in the arm or buttocks.

9 Oct 2015

Tresiba and Ryzodeg approved to improve blood sugar control in adults with diabetes mellitus

The U.S. Food and Drug Administration today approved Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec/insulin aspart injection) to improve blood sugar (glucose) control in adults with diabetes mellitus.

9 Oct 2015

Veterinary News and Research

FDA grants accelerated approval to Praxbind (idarucizumab)

Boehringer Ingelheim announces FDA approval of Praxbind (idarucizumab)

Loyola partners with Cook County Sheriff's Department to hold Medication Take-Back Day on October 20

Boehringer Ingelheim, Lilly announce availability of Synjardy tablets in U.S. pharmacies

Penn researchers show that canine X-linked retinitis pigmentosa can be cured over the long term

CVMA applauds Governor Brown for signing landmark antibiotics bill

FDA orders three duodenoscope manufacturers in the U.S. to conduct postmarket surveillance studies

FDA permits marketing of first CSF nucleic acid-based test for detection of multiple pathogens

Federal judge grants permanent injunction against South Dakota medical laser manufacturer

FDA approves Opdivo to treat patients with advanced non-small cell lung cancer

FDA awards research grants to boost product development for patients with rare diseases

FDA takes major step to put greater emphasis on the prevention of foodborne illness

FDA allows marketing of new EarLens Contact Hearing Device

FDA approves Lonsurf drug for patients with advanced form of colorectal cancer

FDA approves expanded indication for Optune device for brain cancer patients

FDA announces launch of new education campaign to prevent, reduce tobacco use among hip-hop youth

Xuriden (uridine triacetate) now approved for patients with hereditary orotic aciduria

FDA approves Promacta to treat pediatric patients with chronic immune thrombocytopenic purpura

Aristada (aripiprazole lauroxil) extended release injection approved to treat adults with schizophrenia

Tresiba and Ryzodeg approved to improve blood sugar control in adults with diabetes mellitus

Achieving and maintaining ISO 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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