The U.S. Food and Drug Administration issued a draft guidance that, when finalized, will outline the agency’s approach to evaluating the public health importance of food allergens that are not one of the major nine food allergens identified by law in the United States (non-listed food allergens).
Viatris, the drugmaker formerly known as Mylan, agreed to pay $264 million to resolve a class action lawsuit alleging the company engaged in a scheme to delay generic competition to its EpiPen allergy treatment.
BlueWillow Biologics demonstrated the safety and immunogenicity in humans of the company’s intranasal technology, which CEO Chad Costley said is the only adjuvanted intranasal platform that is not virus-based.
Angany entered a partnering agreement to evaluate the safety and efficacy of the French-Canadian pharmaceutical company’s lead peanut allergy biological candidate BP/AH-01 with the Food Allergy Center at Massachusetts General Hospital and MassGeneral Hospital for Children.
Three new conditions reported by a small number of people after vaccination with Covid-19 shots from Pfizer and Moderna are being studied to assess if they may be possible side effects, Europe’s drugs regulator said on Aug. 11.
Pfizer Inc. agreed to pay $345 million to resolve claims by consumers who claim they overpaid for EpiPens due to anticompetitive and unfair practices by the drugmaker and the company that markets the emergency allergy treatment, Mylan.
Idorsia is launching a late-stage trial of the experimental heart-attack drug selatogrel that the Swiss company hopes will become what it describes as akin to an “EpiPen” for people at risk of acute myocardial infarction (AMI).
The U.S. Centers for Disease Control and Prevention is observing a lower rate of severe allergic reactions in people in the United States who have received Pfizer Inc. and BioNTech SE’s Covid-19 vaccine.
Severe allergic reactions to Moderna Inc.’s coronavirus vaccine appear to be quite rare, the U.S. Centers for Disease Control and Prevention (CDC) said, after more than 4 million people received their first dose.
Moderna Inc. received a report from California’s health department that several people at a center in San Diego were treated for possible allergic reactions to the company’s Covid-19 vaccine from a particular batch.