Tag: FDA
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20 Precision Meds Approved by FDA in 2020
A report by a group advocating for precision medicine notes that the Food and Drug Administration approved 20 new personalized drugs and biologics in 2020.
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FDA Clears Covid-19 Dual-Antibody Therapy
The Food and Drug Administration granted an emergency authorization for a combination of two synthetic antibodies to treat non-hospitalized Covid-19 infections.
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Monthly HIV Drug Combo Approved by FDA
The Food and Drug Administration approved a drug regimen given once a month to control HIV infections, to replace daily antiretroviral medications.
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US Govt to Buy 1.25M Regeneron Covid-19 Therapies
The U.S. Department of Health and Human Services is buying up to 1.25 million more doses of Regeneron’s Covid-19 antibody therapy, for $2.63 billion.
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Vaccine Shown Active Against New Covid-19 Variants
A current Covid-19 vaccine is shown in lab tests to produce antibodies that appear to protect against new mutations found in South Africa and the U.K.
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FDA Issues Precision Genomic Drug Guidance
The U.S. Food and Drug Administration issued draft administrative and procedural guidelines for genetic disorders treated with precise gene therapies.
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Trial OKed for Rare Disease Gene Therapy
A start-up biotech company says it received clearance from the Food and Drug Administration to begin a clinical trial of its gene therapy for Krabbe disease.
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Neuro Device Shown to Relieve Adolescent Migraine Pain
Findings from a clinical trial show a wearable device sending electronic signals into the nervous system relieves migraine pain in children age 12 to 17.
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Covid-19 Antibody Developer Raises $483M in IPO
A biotechnology company developing therapeutic antibodies for Covid-19 infections is raising $483 million in its initial public offering of common stock.
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FDA Begins Qualifying Non-Animal Testing Options
The Food and Drug Administration began a pilot program for assessing alternative technologies to test drugs, biologics, and devices without animals.