The attorney general for one of the most populous U.S. states this week urged federal drug regulators to address safety risks associated with the widely used asthma and allergy medicine Singulair, saying current warnings on the drug’s packaging are insufficient, particularly for children.
Tag Archive for: U.S. Food and Drug Administration (FDA)
Pharmaceutical companies last year launched new U.S. drugs at prices 35% higher than in 2022, reflecting in part the industry’s embrace of expensive therapies for rare diseases like muscular dystrophy, a Reuters analysis found.
The FDA has granted Priority Review to Sanofi and Regeneron’s supplemental Biologics License Application seeking to expand its blockbuster antibody therapeutic Dupixent (dupilumab) into chronic obstructive pulmonary disease, the companies announced Friday.
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While Otsuka Pharmaceutical can expect to a drop in sales as its schizophrenia therapy Abilify Maintena (aripiprazole) loses its market exclusivity later this year, the recently approved longer-acting formulation Abilify Asimtufii will help the company buttress its revenues, according to a report Wednesday from data analytics and consulting firm GlobalData.
The U.S. Food and Drug Administration on Wednesday approved Johnson & Johnson unit Actelion Pharmaceuticals’ injection, making it the first-ever treatment to treat severe frostbite in adults.
The FDA on Tuesday approved Ipsen’s Onivyde, when used in combination with three chemotherapeutic drugs, for the treatment of newly diagnosed patients with metastatic pancreatic adenocarcinoma.
Takeda Pharmaceutical’s therapy for an allergic inflammation of the esophagus has received approval from the U.S. FDA, the Japanese drugmaker said on Monday, capping a years-long regulatory process.
The U.S. Food and Drug Administration has placed a clinical hold on Iovance Biotherapeutics’ lung cancer therapy trial after a patient death, the company said on Wednesday.
Amgen announced that the U.S. Food and Drug Administration (FDA) has completed its review of the company’s supplemental New Drug Application seeking full approval of LUMAKRAS® (sotorasib).
Zealand Pharma said on Saturday that the U.S. Food and Drug Administration (FDA) had declined to approve its drug for preventing and treating low blood sugar in children with a genetic disorder after finding deficiencies at a third-party manufacturing facility.