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, Md.-based Novavax said the funding will allow…
FDA Action Alert: Viela, Merck, Epizyme, Evoke and Regeneron
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 Biologics License…
Faster Drug & Medical Device Approvals Under 21st Century Cures Act Raises Patient Safety Concerns
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 devices, creating…
FDA Endorses First Low Cost Biotech Drug
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…
Chimerix Gets FDA OK to Test Drug for Ebola
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 with a trial…
Experimental Drug Provided to Dallas Ebola Patient
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 their patient, Thomas Eric…
Vivolux Cancer Drug Receives FDA Clearance for Clinical Study
Vivolux, a pharmaceutical company specialized in cancer treatment, announced that the FDA has granted clearance to proceed with VLX1570 Clinical Trial phase 1/2 for treatment against relapsed and/or refractory multiple myeloma. Researchers at Vivolux have discovered a novel cancer drug target…
FDA: Little Evidence to Support Testosterone Drugs
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 testosterone therapy risks. The agency posted its…
AIDS Activist Fights for FDA
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 Drug…
FDA Approves Inhalable Diabetes Drug Afrezza
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 mealtime use, for adults with the…