Tag: FDA

The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.

Only 41 Percent Clinical Trials of US Comply with Reporting Regulations

A new study has revealed that only 41 percent of US clinical trials reported their findings to the trial registry within the year time limit mandated by the US Food and Drug Administration Amendment A...

A Chinese OTC Drugmaker Gets a FDA Warning Letter

The FDA posted a warning letter this week for Huaian Zongheng Bio-Tech for its plant in Huaian, China, which it says makes over-the-counter drug products, many of them for children. It says the compan...

Possible Increased Risk of Cancer with the Medicine Belviq

The U.S. Food and Drug Administration (FDA) is alerting the public that results from a clinical trial assessing safety show a possible increased risk of cancer with the weight management medicine Belv...

Due to Сross-contamination, Taro is Voluntarily Recalling One lot of its Lamotrigine

The US Food and Drug Administration (FDA) has announced that Taro Pharmaceuticals is voluntarily recalling one lot of its lamotrigine tablets, indicated for epilepsy and bipolar disorder. The annou...

Mylan, Appco and Denton are Voluntarily Recalling Products Due to Unacceptable Levels of NDMA

таблетки
The US Food and Drug Administration (FDA) has announced that two companies are voluntarily recalling batches of ranitidine tablets and one company is voluntarily recalling lots of nizatidine tablets i...

FDA Approved sNDA to Update Label for Flexion Zilretta

Flexion Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) to update the product label for ZILRETTA (triamcinolone ac...

Immunomedics Announced FDA Acceptance of BLA for Sacituzumab Govitecan Approval

drugs
Immunomedics, Inc., a leading biopharmaceutical company in the area of antibody-drug conjugates, announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s Biolog...

FDA Approved 48 New Medicines in 2019

fda office
After a flurry of activity in December, when the FDA approved seven new molecular entities (NMEs), the total of novel drugs that were given the green light this year reached 48, a number that ranks th...

Urovant Seeks FDA Approval for Vibegron

documents
Urovant Sciences announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of once-daily 75mg vibegron for the treatment of patients ...

MorphoSys AG Submitted BLA to FDA for Tafasitamab

MorphoSys AG, announced that it has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for tafasitamab, an anti-CD19 antibody, for the treatment of relapsed o...

FDA Granted Breakthrough Therapy Designation for Molgradex

Savara Inc., an orphan lung disease company, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for Molgradex, an inhaled formulation of recombinan...

Efforts to Improve Quality of Compounded Drugs from Outsourcing Facilities Taken by FDA

fda office
Compounded drugs can serve an important role in meeting patients’ medical needs that cannot be met by an FDA-approved drug. Outsourcing facilities, a significant part of the industry producing compoun...

FDA Issued Complete Response Letter on Brinavess Approval

Correvio Pharma announced that the FDA issued a complete response letter regarding its filing seeking approval of Brinavess (vernakalant) for the rapid conversion of recent-onset atrial fibrillation i...

FDA Sent Response Letter to ViiV Healthcare on Cabotegravir and Rilpivirine Use

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, received a complete response letter (CRL) from the US Food and Drug Adm...

FDA Issued Two New Warnings to Drugmakers

The US Food and Drug Administration (FDA) recently warned Massachusetts-based device maker Conformis Inc. and Australian over-the-counter (OTC) drugmaker Wild Child WA Pty Ltd. for good manufacturing ...

Epizyme Submitted NDA to FDA for Accelerated Approval of Tazemetostat

Epizyme, Inc., a late-stage biopharmaceutical company developing novel epigenetic therapies, announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA)...