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: Pocas pruebas que respalden los medicamentos con testosterona
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…
Activista contra el SIDA lucha por la FDA
En esta foto del 22 de julio de 2014, el activista contra el SIDA Gregg Gonsalves camina por el exterior de la estación Grand Central Terminal durante una sesión fotográfica en Nueva York. A principios de la década de 1990, Gonsalves viajó a Washington para confrontar, provocar y desafiar a los funcionarios de la Administración de Alimentos y Medicamentos...
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…