AstraZeneca and Amgen’s Tezspire (Tezepelumab) Secures the EU Approval for Severe Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

Shots:The EU approved Tezspire as an add-on treatment with intranasal corticosteroids for adults with severe CRSwNP unresponsive to standard therapies; regulatory review is ongoing in China, Japan, and several other countriesApproval was based on the P-III (WAYPOINT) study assessing Tezspire (SC) vs PBO to treat adults with severe CRSwNP for 52wks., followed by…

ByDipanshu Dixit3 days ago

NEWS

AstraZeneca and Amgen Report the CHMP’s Positive Opinion of Tezspire (Tezepelumab) for CRSwNP

Shots:The CHMP has recommended Tezspire for the treatment of Chronic Rhinosinusitis with Nasal Polyps (CRSwNP); regulatory review is ongoing in the US, China, Japan & other countriesOpinion was based on the P-III (WAYPOINT) study assessing Tezspire (SC) vs PBO to treat adults with severe CRSwNP for 52wks., followed by a post-treatment follow-up duration…

ByRidhi RastogiSeptember 24, 2025

VIEWPOINTS

ATS 2024: Robert Fogel, Janet Franklin, and Dave Singh from AstraZeneca & Amgen in Conversation with PharmaShots

Shots: Recently AstraZeneca and Amgen presented the results in late-breaking session from the COURSE trial, a proof-of-concept study evaluating tezepelumab in COPD The PoC study was carried out in people with moderately to very severe COPD with a broad range of eosinophil levels Today, at PharmaShots we have Robert Fogel from AstraZeneca, Janet Franklin from…

BySaurabh ChaubeyOctober 8, 2024

INSIGHTS+

Insights+: The US FDA New Drug Approvals in February 2023

Shots:The US FDA approved 5 NDAs and 5 BLA in February 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 19 novel products in 2023In February 2023, the major highlights drugs were, Tezspire (tezepelumab) approval for severe asthma, Altuviiio for hemophilia APharmaShots has compiled…

BySenior EditorMarch 15, 2023

AstraZeneca and Amgen’s Tezspire (Tezepelumab) Secures the EU Approval for Severe Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

AstraZeneca and Amgen Report the CHMP’s Positive Opinion of Tezspire (Tezepelumab) for CRSwNP

ATS 2024: Robert Fogel, Janet Franklin, and Dave Singh from AstraZeneca & Amgen in Conversation with PharmaShots

Insights+: The US FDA New Drug Approvals in February 2023

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