Healio

Top in allergy/asthma: FDA OKs Xolair; commercial sparks conversation about food allergies

Please provide your email address to receive an email when new articles are posted on . The FDA has approved Xolair for the reduction of allergic reactions in children and adults with immunoglobulin E ...
Yahoo Finance

Amneal Announces BLA Submission of Biosimilar Candidate to XOLAIR® (omalizumab)

BRIDGEWATER, N.J., Sept. 26, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced the submission of a Biologics License Application (BLA) to ...
Seattle Times

What to know about Xolair and food allergies

The Food and Drug Administration approved a drug this month that cuts the risk of severe reactions in children and adults exposed to trace amounts of peanuts, tree nuts, milk, dairy and other food ...
Pharm Exec

Xolair Approved by FDA as First Treatment for Multiple Food Allergies in Adult, Pediatric Patients

Novartis’ and Roche’s Xolair (omalizumab) is indicated to treat severe allergic reactions after accidental exposure to one or more foods in individuals aged one year and above. The FDA has approved an ...
Nasdaq

Alvotech, Kashiv Biosciences, and Advanz Pharma Announce Positive Results for AVT23, a Proposed Biosimilar to Xolair®

Positive topline results from the confirmatory efficacy study for AVT23 indicate its potential as an effective biosimilar to Xolair®, supporting the company's commitment to expanding its biosimilar ...
Mena FN

FDA Approves Xolair® (Omalizumab) As First And Only Medicine For Children And Adults With One Or More Food Allergies

"Many people with food allergies and their loved ones live in constant fear of accidentally coming into contact with the food they are allergic to and the life-threatening allergic reaction that could ...
Business Wire

Kashiv BioSciences Enters into Exclusive Licensing Agreement with Amneal for Commercialization of a Proposed Biosimilar to XOLAIR® (Omalizumab)

PISCATAWAY, N.J.--(BUSINESS WIRE)--Kashiv BioSciences, LLC (“Kashiv” or the “Company”) today announced that it has entered into an exclusive licensing agreement for ADL018, a proposed biosimilar to ...
Fierce Healthcare

Micromet Demonstrates That the Antibodies in Commercial Products Herceptin, Erbitux, Vectibix and Xolair Can Be Converted Into H

Micromet Demonstrates That the Antibodies in Commercial Products Herceptin, Erbitux, Vectibix and Xolair Can Be Converted Into H Apr 14, 2008 5:21pm Providers ...
Medindia

Celltrion announces U.S. FDA approval of 300mg strength of OMLYCLO® (omalizumab-igec), the first and only FDA-approved interchangeable biosimilar to XOLAIR®

U.S. Food and Drug Administration (FDA) has approved a new presentation of OMLYCLO® (omalizumab-igec), the first and only biosimilar designated as interchangeable with XOLAIR® (omalizumab), in a 300mg ...

Kashiv Biosciences Announces Submission of Biologics License Application to U.S. FDA and Acceptance of Market Authorization Application by European Medicines Agency for ADL-018 ...

Alvotech partnered with Kashiv BioSciences for the development of the proposed XOLAIR ® biosimilar, which is referred to as AVT23 by Alvotech and as ADL-018 by Kashiv Biosciences. Use of trademarks ...
CNN

FDA approves medication used to treat asthma for use in people with multiple food allergies

The US Food and Drug Administration on Friday approved a medication called Xolair to help lessen the severity of an accidental allergic reaction in people who are allergic to multiple foods. Xolair, ...
ksn.com

FDA approves Xolair® (omalizumab) as first and only medicine for children and adults with one or more food allergies - KSN-TV

Approval is based on data from the NIH-sponsored Phase III OUtMATCH study, which showed a significantly higher proportion of food allergy patients as young as 1 year treated with Xolair could tolerate ...