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 DixitOctober 23, 2025

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

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

INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in January 2023

Shots:The EMA approved 3 New Chemical Entity (NCE) and 5 Biologic Drugs in January 2023, leading to treatments for patients and advances in the healthcare industryIn January 2023, the major highlights drugs were Xofluza’s Approval for influenza, Dupixent for eosinophilic esophagitisPharmaShots has compiled a list of a total of 8 new drugs…

BySenior EditorFebruary 23, 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

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

Insights+: EMA Marketing Authorization of New Drugs in January 2023

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