FDA

Syndicate content

FDA Advisory Committee Did Not Recommend Approval of Zimulti

The Committee did not recommend its approval for us in obese and overweight patients with associated risk factors

Get the full story...

FDA Implementing Initiative to Reduce Tomato-Related Foodborne Illnesses

The U.S. Food and Drug Administration (FDA) will begin a multi-year Tomato Safety Initiative to reduce the incidence of tomato-related foodborne illness in the United States.

Get the full story...

Toothpaste From China Containing Harmful Chemical?

FDA Detains One Contaminated Shipment of Chinese Toothpaste, Issues Import Alert

Get the full story...

Novagali Pharma receives US FDA Orphan Drug Designation for Vekacia for the treatment of Vernal Keratoconjunctivitis

Novagali Pharma, an emerging ophthalmic pharmaceutical company, announced on May 25th that orphan drug designation granted by the U.S. Food and Drug Administration (FDA) to Cyclosporine A drug Vekacia®, a patented cationic emulsion, for the treatment of Vernal Keratoconjunctivitis (VKC).

Get the full story...

FDA Approves the "No-Period" Pill - Contraceptive Drug Preventing Pregnancy

On May 22nd, the US Food and Drug Administration (FDA) approved Lybrel, the first continuous use drug product for prevention of pregnancy.

Get the full story...

FDA Approves New Hope for Schizophrenia

On May 18th, AstraZeneca (NYSE: AZN) announced that the U.S. Food and Drug Administration (FDA) has approved SEROQUEL XR(TM) (quetiapine fumarate) Extended-Release Tablets, a once-daily medicine for the treatment of schizophrenia in adult patients.

Get the full story...

Neupro Patch for the Treatment of Early Parkinson's Disease Symptoms

US FDA Approves SCHWARZ PHARMA's Neupro (Rotigotine Transdermal System) for the Treatment of Early-Stage Parkinson's Disease in USA

Get the full story...

First U.S. Vaccine for Humans Against Bird Flu Approved By FDA

An important milestone in pandemic preparedness is reached as FDA approves the first human vaccine for avian influenza H5N1.

Get the full story...

FDA approves Tykerb and Xeloda for the treatment of advanced or metastatic breast cancer

FDA approves Tykerb (lapatinib) in combination with Xeloda (capecitabine) for the treatment of advanced or metastatic breast cancer in women who have progressed on prior therapy. GlaxoSmithKline's New Breast Cancer Drug May Give Women More Options

Read the full story

Amgen Updates U.S. Prescribing Information for Aranesp, EPOGEN

New Boxed Warning Applies to Oncology and Nephrology Indications for the Class of Approved ESAs.

Read the full story

FDA Issues Draft Documents on The Safety of Animal Clones

Agency Continues to Ask Producers and Breeders Not to Introduce Food from Clones into Food Supply

The U.S. FDA today issued three documents on the safety of animal cloning - a draft risk assessment; a proposed risk management plan; and a draft guidance for industry. The draft risk assessment finds that meat and milk from clones of adult cattle, pigs and goats, and their offspring, are as safe to eat as food from conventionally bred animals.

Read the full story

SCAI president testifies before FDA on safety of drug-eluting stents

Interventional cardiologist urges panel to consider DES benefits when evaluating risks of late blood clot formation

Read the full story