Medscape10d
Omalizumab vs Oral Immunotherapy: No Clear Winner
Last year, the US Food and Drug Administration (FDA) approved omalizumab— an injectable medication already used for allergic asthma, chronic hives, and nasal polyps — for food allergies in ...
MedPage Today12d
First Omalizumab Biosimilar Approved
Opens in a new tab or window Share on LinkedIn. Opens in a new tab or window The FDA approved omalizumab-igec (Omlyclo) as the first biosimilar for omalizumab (Xolair) and the first for any ...
Monthly Prescribing Reference18d
Omalizumab vs OIT: Head-to-Head Study Compares Food Allergy Treatments
Thirty-six percent of patients treated with omalizumab were able to tolerate 2000mg of peanut protein and 2 other food allergens without experiencing an allergic reaction compared with 19% of OIT ...
Healio15d
FDA approves omalizumab biosimilar Omlyclo
Omlyclo is the first interchangeable biosimilar to omalizumab (Xolair; Genentech, Novartis). Omlyclo was approved to treat the same conditions as Xolair. The FDA approved Celltrion’s omalizumab ...
Healio29d
Families ‘thrilled’ with omalizumab in the year since its approval for food allergy
Robert A. Wood, MD, FAAAAI, looks back on the first year of omalizumab’s use for food allergy. Patients often are allergic to multiple foods or to foods that are difficult to avoid. Perspective ...
Rolling Out12d
New drug outperforms therapy for severe food allergies
A landmark clinical trial has discovered that omalizumab, marketed as Xolair, provides more effective treatment for multiple food allergies than the current standard approach of oral immunotherapy ...
Medscape9d
FDA Approves First Biosimilar to Omalizumab
The US Food and Drug Administration (FDA) has approved the first biosimilar form of omalizumab (Xolair) for the treatment of a range of allergic conditions. Omalizumab-igec (Omlyclo) is designed ...
Drug Store News10d
FDA approves Celltrion's Xolair biosimilar
The Food and Drug Administration has approved Celltrion’s Omlyclo (omalizumab-igec) as a biosimilar designated as interchangeable with Xolair (omalizumab) for the treatment of moderate to severe ...
Morningstar13d
U.S. FDA approves Celltrion's OMLYCLO® (omalizumab-igec) as the first and only biosimilar with interchangeability designation referencing XOLAIR®
JERSEY CITY, N.J., March 9, 2025 /PRNewswire/ -- Celltrion today announced the U.S. Food and Drug Administration (FDA) approved OMLYCLO® (omalizumab-igec) as the first and only biosimilar ...
Finanznachrichten13d
U.S. FDA approves Celltrion's OMLYCLO (omalizumab-igec) as the first and only biosimilar with interchangeability designation referencing XOLAIR
OMLYCLO ® (omalizumab-igec) is the first and only omalizumab biosimilar approved by the FDA Regulatory approval for interchangeability was supported by positive phase III data demonstrating ...
Pharm Exec12d
FDA Approves Celltrion’s Xolair Biosimilar Omlyclo for Multiple Indications
Omlyclo, a biosimilar to Xolair, is indicated for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, immunoglobulin E-mediated food allergies, and chronic ...
Joplin Globe20d
Phase III Study Shows Xolair May Be More Effective With Fewer Side Effects Than Oral Immunotherapy for the Treatment of Food Allergies
Stage 2 of the OUtMATCH study showed Xolair was more effective with fewer side effects than multi-allergen oral immunotherapy (OIT) in the first-ever head-to-head trial comparing the two treatment ...