-
FDA News Month in Review: March 2025
31 Mar 2025 20:32 GMT
… biosimilar to omalizumab (Xolair) and the first … 2 and EAGLE-3 trials, where gepotidacin demonstrated … uropathogens, including drug-resistant strains.
FDA Issues CRL for … Milestone Pharmaceuticals'; etripamil nasal spray (Cardamyst) for the treatment of …
-
MHRA Confirms Acceptance of Marketing Authorization Application for Proposed Biosimilar to Xolair®
27 Mar 2025 20:04 GMT
… proposed biosimilar to Xolair® (omalizumab), a biologic indicated for treatment of severe … , hospital, and rare disease medications.”
Alvotech and Advanz Pharma announced … get special offers
from American Pharmaceutical Review – all delivered right to …
-
UK Medicines and Healthcare Products Regulatory Agency Confirms Acceptance of Marketing Authorization Application for Proposed Biosimilar to Xolair® (omalizumab)
26 Mar 2025 08:30 GMT
… biotech company specializing in the development and manufacturing of biosimilar medicines … biosimilar to Xolair® (omalizumab), a biologic indicated for treatment of severe … Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), …
-
UK Medicines and Healthcare Products Regulatory Agency has Validated and Accepted the Marketing Authorization Application for ADL-018, a Proposed Biosimilar of Xolair® (omalizumab)
26 Mar 2025 13:01 GMT
… announced that the UK Medicines and Healthcare Products Regulatory … Company’s proposed biosimilar for Xolair® (omalizumab). The acceptance … to the reference product, Xolair®, in terms of quality, … cost-effective alternative to Xolair®," said Chirag and …
-
ARS Pharmaceuticals, Inc. (NASDAQ:SPRY) Q4 2024 Earnings Call Transcript
22 Mar 2025 13:29 GMT
… March 20, 2025
ARS Pharmaceuticals, Inc. beats earnings expectations … process is streamlined, allowing doctors to more easily send … validated by the successful treatment of patients with allergic … from public programs like Medicaid? Thank you.
Richard …
-
New policy changes the way Texans get asthma medication
22 Mar 2025 01:24 GMT
… that shift certain asthma injectable medications their patients receive in-clinic … patients use the biological injectable treatment Xolair across the nation.
Also, the … if you’re in a doctor’s office it’s easily …
-
Tezepelumab Shows Sustained Post-Treatment Benefit in Chronic Spontaneous Urticaria Despite Missed Primary Endpoint
19 Mar 2025 22:04 GMT
… ; AstraZeneca, Amgen) had post-treatment reductions in chronic spontaneous urticaria … of the phase 2b clinical trial, INCEPTION (NCT04833855). The investigators … ) with omalizumab (Xolair; Novartis Pharmaceuticals), which is currently FDA-approved in patients …
-
FDA Approves Celltrion’s OMLYCLO® (omalizumab-igec)
19 Mar 2025 23:50 GMT
… only biosimilar of XOLAIR® (omalizumab). The FDA approved OMLYCLO® with … and safety profile with XOLAIR® (omalizumab), which is … is indicated for the treatment of moderate to severe … Hetal Patel, Vice President of Medical Affairs at Celltrion, stated …
-
Risk factors impact denials, wait times, discontinuations in biologic treatment for asthma
17 Mar 2025 19:10 GMT
… times more likely than treatment with omalizumab (Xolair; Genentech/Novartis) to … more likely to discontinue treatment than patients with Medicaid (OR = 2.65 … interventions navigate patients through the medication authorization, approval, appeal and …
-
Top Growth Driver In The Xolair Market 2025: Impact Of Rising Asthma Prevalence On The Growth Of The Market
17 Mar 2025 05:00 GMT
… of approved indications for Xolair (omalizumab) to address unmet medical needs.
In … La Roche Ltd. secured FDA approval for Xolair omalizumab to help prevent … #47;autoimmune-treatment-global-market-report
Anti-Asthmatics And COPD Drugs Global Market …