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Home » FDA

Posts tagged: FDA

Novavax

Novavax Secures $1.6 Billion from U.S. Government for COVID-19 Vaccine Program

July 7, 2020
by marketing_fomat Blogs & Updates

With rising numbers of COVID-19 infections and as the fight against the novel coronavirus continues, Novavax received $1.6 billion in federal funding to support the clinical development of the company’s vaccine candidate, NVX‑CoV2373. Gaithersburg, ...

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FDA

FDA Action Alert: Viela, Merck, Epizyme, Evoke and Regeneron

June 9, 2020
by marketing_fomat Blogs & Updates

The next two weeks are busy ones for the U.S. Food and Drug Administration (FDA). Here’s a look at PDUFA dates for this period. Viela Bio’s Inebilizumab for NMOSD Gaithersburg, Maryland-based Viela Bio has a target action date of June 11 for its Bi ...

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FDA Approvals Illustration Medical Devices and Drug Approvals

Faster Drug & Medical Device Approvals Under 21st Century Cures Act Raises Patient Safety Concerns

January 16, 2017
by fomat_medical Blogs & UpdatesMedical DevicesNews

President Obama signed a bill that will provide US$6 billion in federal funding for basic medical research on Dec. 13. Called the 21st Century Cures Act, it also introduces changes to how the Food and Drug Administration approves drugs and medical de ...

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FDA

FDA Endorses First Low Cost Biotech Drug

January 9, 2015
by fomat_medical Blogs & Updates

  Federal health experts have unanimously endorsed a Novartis drug which is expected to become the first lower-cost copy of a biotech drug to reach the U.S. market. A panel of Food and Drug Administration experts ruled that the company's version of N ...

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FDA

Chimerix Gets FDA OK to Test Drug for Ebola

October 20, 2014
by fomat_medical Blogs & Updates

   A North Carolina drugmaker plans to test its experimental antiviral drug in patients who have Ebola, after getting authorization from regulators at the Food and Drug Administration. Chimerix Inc. said that it has received FDA clearance to proceed ...

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ebola

Experimental Drug Provided to Dallas Ebola Patient

October 8, 2014
by fomat_medical Blogs & Updates

A North Carolina drugmaker is providing its experimental antiviral drug to a Dallas patient being treated for Ebola, an emergency step authorized by the Food and Drug Administration.  Officials at Texas Health Presbyterian Hospital said Monday that ...

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FDA

Vivolux Cancer Drug Receives FDA Clearance for Clinical Study

October 8, 2014
by fomat_medical Blogs & Updates

Vivolux, a pharmaceutical company specialized in cancer treatment, announced that the FDA has granted clearance to proceed with VLX1570 to clinical phase 1/2 for treatment against relapsed and/or refractory multiple myeloma. Researchers at Vivolux h ...

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FDA

FDA: Little Evidence to Support Testosterone Drugs

September 4, 2014
by fomat_medical Blogs & Updates

The Food and Drug Administration says there is little evidence that testosterone-boosting drugs taken by millions of American men are beneficial, though the agency is also unconvinced by studies suggesting the hormone carries serious risks. The agen ...

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Aids Activism Illustration of Discrimination Crowds Gather to Protest

AIDS Activist Fights for FDA

August 20, 2014
by fomat_medical AidsBlogs & UpdatesNews

In this July 22, 2014 photo, AIDS activist Gregg Gonsalves walks outside Grand Central Terminal during a photo session, in New York. In the early 1990s, Gonsalves traveled to Washington to confront, provoke and challenge officials at the Food and Dru ...

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FDA

FDA Approves Inhalable Diabetes Drug Afrezza

July 1, 2014
by fomat_medical Blogs & Updates

The Food and Drug Administration on Friday approved a long-delayed inhalable diabetes medication to help patients control their blood sugar levels during meals. The FDA cleared MannKind Corp.'s Afrezza, a fast-acting form of insulin, for adults with ...

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