Cough, fever, and breathing difficulty could signal a Covid-19 infection. It could also be the flu. A Lucira Health diagnostic is now the first one authorized by the FDA to identify the culprit virus…
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A Fulcrum Therapeutics clinical trial testing a potential sickle cell disease drug has been paused by the FDA. With the clinical hold on the early-stage study, Fulcrum becomes the fourth company with a stalled…
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Hemophilia A patients manage the chronic disorder with infusions administered as frequently as every two to three days. The FDA has approved a Sanofi drug designed to last longer in the body, giving patients…
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The vast majority of the critically essential secrets in biology are hidden from researchers. The human microbiome is now considered a human organ, yet the word “microbiome” was not in the research lexicon as…
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AbbVie turned to Capsida Biotherapeutics two years ago for help delivering gene therapies into the brain. That partnership is ongoing, but the pharmaceutical giant now wants to leverage its partner’s technology for delivery of…
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In June, the United States Supreme Court abandoned nearly 50 years of precedent and, for the first time in this nation’s history, eliminated a fundamental right: the right to choose. This decision, Dobbs v….
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Editor’s note: This story is based on an interview at Abarca Forward, a conference that was hosted by Abarca Health, a pharmacy benefit manager last week in San Juan, Puerto Rico. MedCity News’ Editor-in-Chief…
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Travere Therapeutics has won FDA approval for a drug that treats a rare autoimmune disorder that is typically first noticed as blood in the urine and can progress over time to end-stage kidney failure.
The…
Geographic atrophy, an eye disorder that starts as a loss of central vision and progressively worsens to total blindness, now has its first treatment. The FDA on Friday approved an Apellis Pharmaceuticals drug that slows the progression of this disease, which affects more than 1 million people in the U.S.
Approval of the Apellis drug, pegcetacoplan, covers all patients with geographic atrophy, a broad label that reflects the representative patient population tested in pivotal studies, Chief Medical Officer Caroline Baumal said during a Friday evening conference call. The Waltham, Massachusetts-based company plans to launch the drug in March, marketing the product under…
A Chiesi Farmaceutici drug for a rare enzyme deficiency is now approved by the FDA, making it the first U.S. treatment for a disorder that leads to a range of cognitive and muscle problems.
The regulatory decision announced late Thursday covers the treatment of children and adults who have alpha-mannosidosis (AM), a disease caused by a genetic mutation that leads to defective or inactive forms of an enzyme called alpha-D-mannosidase. Chiesi’s drug, velmanase alfa, is an engineered version of that enzyme. The privately held Italian company will market its new FDA-approved drug as Lamzede, the same name for the product in Europe,…
