FDA clears TransOral robotic surgery developed at Penn

Contact: Kim Guenther
kim.guenther@uphs.upenn.edu
215-200-2312
University of Pennsylvania School of Medicine Read more

FDA Orders Strong Warning Labels on Darvon, Darvocet

The U.S. Food and Drug Administration is taking several actions to reduce the risk of overdose in patients using pain medications such as Darvon and Darvocet that contain propoxyphene. The actions were taken because of data linking propoxyphene and fatal overdoses.

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FDA Approves Simponi To Treat Rheumatoid Arthritis

The U.S. Food and Drug Administration (FDA) has approved a new drug known as Simponi to treat rheumatoid arthritis.

Simponi, known generically as golimunab, has been given the green light to treat three different types of arthritis in total.

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FDA Approves Two Hologic HPV Tests

Hologic, Inc., (Hologic or the Company) (Nasdaq: HOLX), a leading women’s healthcare company dedicated to serving the healthcare needs of women, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s premarket approval (PMA) applications for both the Cervista(TM) HPV HR (high risk) and the Cervista HPV 16/18 tests. Cervista HPV HR, designed to detect the 14 high-risk types of human papillomavirus (HPV) known to cause cervical cancer, is the first HPV DNA test approved by the FDA in more than 10 years. Cervista HPV 16/18 is the first HPV test approved for genotyping for HPV types 16 and 18, known to be associated with approximately 70% of all cervical cancers in the United States.

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FDA Approves KAPIDEX(TM) (Dexlansoprazole) delayed release capsules for the Treatment of GERD

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc., today announced that the U.S. Food and Drug Administration (FDA) approved KAPIDEX(TM) (dexlansoprazole) delayed release capsules for the once-daily, oral treatment of heartburn associated with symptomatic non-erosive Gastroesophageal Reflux Disease (GERD), the healing of erosive esophagitis (EE) and the maintenance of healed EE. KAPIDEX (30 mg and 60 mg) is the first proton pump inhibitor (PPI) with a Dual Delayed Release(TM) (DDR) formulation designed to provide two separate releases of medication.

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FDA Approves KAPIDEX(TM) (Dexlansoprazole) delayed release capsules for the Treatment of GERD

First proton pump inhibitor (PPI) with a Dual Delayed Release(TM) (DDR) formulation

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc., today announced that the U.S. Food and Drug Administration (FDA) approved KAPIDEX(TM) (dexlansoprazole) delayed release capsules for the once-daily, oral treatment of heartburn associated with symptomatic non-erosive Gastroesophageal Reflux Disease (GERD), the healing of erosive esophagitis (EE) and the maintenance of healed EE. KAPIDEX (30 mg and 60 mg) is the first proton pump inhibitor (PPI) with a Dual Delayed Release(TM) (DDR) formulation designed to provide two separate releases of medication.

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Merck’s Gardasil Vaccine Gets Expanded Indications

The FDA approved the use of Mercks human papillomavirus (HPV) vaccine Gardasil to prevent vulvar and vaginal cancer, according to a Sept. 12 approval letter. Gardasil had been approved to prevent cervical cancer. Its labeling has been updated to note that available information is insufficient to support use beyond age 26, the current FDA-approved age, the agency says. Also, new information has been added showing that Gardasil does not protect against diseases caused by HPV types not contained in the vaccine.

FDA to List Drugs Being Investigated

Complaints Will Be Posted Quarterly

The Food and Drug Administration will begin posting every three months a list of drugs whose safety is under investigation because of complaints brought to the agency’s attention by drug companies, physicians and patients.

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U.S. FDA approves Amgen’s blood platelet booster

Amgen Inc drug Nplate is safe and effective for treating a rare clotting disorder that can cause dangerous bleeding, the Food and Drug Administration said on Friday in approving the product for U.S. sales.

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FDA Investigates Possible Vytorin-Cancer Link

But the agency says patients can still take the cholesterol-lowering drug

U.S. drug regulators said Thursday that they were investigating whether the cholesterol-lowering drug Vytorin might be linked to cancer.

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