FDA

Natpara Receives Approval from US FDA for treatment of hypoparathyroidism

Natpara Receives Approval from US FDA for treatment of hypoparathyroidism

The US Food and Drug Administration (FDA) review team has approved biopharmaceutical company NPS Pharmaceuticals' Natpara to control hypocalcemia in patients with hypoparathyroidism.

Laboratories: 
News: 
Location: 

Salmonella 'outbreak': 2 brothers charged for fake Certificates

Salmonella 'outbreak': 2 brothers charged for fake Certificates

The US Food and Drug Administration and the Centers for Disease Control and Prevention investigationsuncovered a national outbreak of salmonella earlier in 2009.

Location: 
News: 
Laboratories: 

First Generic Version of Celebrax Approved by FDA

First Generic Version of Celebrax Approved by FDA

The U.S. FDA has approved the generic version of painkiller Celebrex (celecoxib) capsules. The cox-2 inhibitor has been a blockbuster drug for treatment of rheumatoid arthritis, osteoarthritis and other painful conditions.

FDA granted approval to Teva Pharmaceuticals for generic version of celecoxib capsules. The capsules will be available in 50mg, 100mg, 200mg and 400mg dosage. The use of non-steroidal anti-inflammatory drugs (NSAID) has increased in the recent years.

Location: 
Laboratories: 

Petco to Stop Carrying Pet Treat from China over Potential Risk of Death for Animals

Petco to Stop Carrying Pet Treat from China over Potential Risk of Death for Ani

Petco has emerged as the first national chain to stop carrying pet treats from China by the end of 2014. The announcement for the same was made by the company after noticing over 1,000 deaths of American dogs and more than 5,600 illnesses linked with jerky treats made in China.

Person: 
Location: 
News: 
Laboratories: 
Company: 

FDA Approves Robotic Arm that Closely resembles Natural Motion of Original Arm

FDA Approves Robotic Arm that Closely resembles Natural Motion of Original Arm

The US Food and Drug Administration has given a green signal to a robotic arm for amputees, named 'Luke' for its similarities to Luke Skywalker's bionic arm in Star Wars. Deka Research and Development has developed the prosthetic arm, which is of the same size, weight and shape like an adult's arm. The best thing about the arm is its ability to provide the same grip as original hand does.

Laboratories: 
News: 
Location: 

Anti-Clotting drug Zontivity Approved by FDA for Heart Attacks

Anti-Clotting drug Zontivity Approved by FDA for Heart Attacks

The U.S. FDA has approved Merck anti-clotting drug Zontivity (vorapaxar) for high-risk group of heart patients. The drug has been recommended for reducing cardiovascular ailment related deaths and stroke.

The drug will be sold under brand name Zontivity in the United States. In January, the FDA panel had voted 10-1 in favor of the drug approval for heart attacks and stroke patients. The delay is approval was due to further checks by FDA team regarding the reports of fatal bleeding among some patients.

Location: 
Laboratories: 
Company: 

FDA Panel Rejects OTC allergy drug Singulair

FDA Panel Rejects OTC allergy drug Singulair

The U.S. FDA panel has rejected Merck’s application for approval of its prescription drug Singulair as over the counter medication. The FDA panel voted 11-4 against the asthma and allergies drug Singulair.

Singulair has been a blockbuster drug for Merck for years. However, the sales have dropped as the patent expired in 2012. The generic versions are available at lower price and Merck aimed at OTC status for the drug to revive sales.

Location: 
Laboratories: 
Company: 

HPV Test for Cervical Cancer Screening approved by U.S. FDA

HPV Test for Cervical Cancer Screening approved by U.S. FDA

The U.S. FDA has approved a genetic test developed by Roche AG as an alternative to Pap smear. The cobas HPV test has been approved for screening of women above 25 years of age. The test checks for HPV DNA in cervical cells.

Almost all cases of cervical cancer are caused due to HPV virus. HPV, or the Human Papillomavirus, is the most common sexually transmitted infection in the United States as per CDC data. The Roche test can detect 14 types of high-risk HPV. Two of these account for 70 percent cases of cervical cancer.

Laboratories: 
News: 
Company: 

Investors Dump QRxPharma after Painkiller Rejected by U.S. FDA Panel

Investors Dump QRxPharma after Painkiller Rejected by U.S. Panel

Australian pharmaceutical major QRxPharma Limited stock plunged nearly 80% after the U.S. regulatory panel voted against the painkiller Moxduo. The stock went down from 70 cents to 13 cents, marking the worst day for the stock since its initial offer in 2007.

Moxduo is a strong painkiller suggested for intense pain and combines two opiods. Moxduo, the drug that combines morphine and oxycodone, failed to receive FDA backing.

The FDA panel unanimously voted against Moxduo. FDA panel added that the drug has not been proved safer compared to other options.

Person: 
Location: 
Laboratories: 
Company: 

Sarepta Drug Eteplirsen to be Reviewed by FDA under Accelerated Approval Pathway

Sarepta Drug Eteplirsen to be Reviewed by FDA under Accelerated Approval Pathway

Sarepta Therapeutics announced that U.S. FDA has indicated alternate path to approval for its muscle disorder drug. The experimental drug to arrest the progression of Duchenne muscular dystrophy in young boys was not able to convince the FDA panel over the last few months. The latest news has raised fresh hope for the approval of the drug. Sarepta Therapeutics stock jumped nearly 64 percent in the stock market after the positive news.

Laboratories: 

Pages

Popular Stories

Uber’s net loss declines as ride bookings grow

Uber Technologies reported lower loss by nearly 9... Read More

Samsung Galaxy Note 8 facing challenges on multiple fronts

The Samsung Galaxy Note 8 is facing an increasingly... Read More

Leaked reports reveal more about new BMW M5

Luxury carmaker BMW’s next-generation M5 car will... Read More

Tesla announces risky new approach to customer service

During the past few years, Tesla was slammed by a... Read More

Facebook downranks video clickbait & fake play buttons

Facebook, the world’s most-popular social-... Read More