The authority follows the suggestions of the WHO Technical Advisory Group on the Composition of COVID-19 Vaccines, in addition to the optimistic opinion of the CHMP.
Pfizer Inc. introduced (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) that the European Fee (EC) has authorized the omicron-modified monovalent vaccine JN.1 (COMIRNATY® JN.1) for an energetic vaccine towards COVID -19 on brought on by SARS-CoV-2 in people from 6 months of age … + learn extra
EMA recommends approval of Moderna vaccine towards Covid-19 modified to new subversion XBB.1.5
The modified Covid-19 vaccine ‘Spikevax’ (Moderna) which targets the Omicron XBB.1.5 subtype has been authorized.
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SEPAR expresses its concern concerning the extension of the approval of the brand new Anti-Tobacco Plan
Assertion from the Spanish Society of Pulmonology and Thoracic Surgical procedure (SEPAR) concerning the extension of the approval of the brand new Anti-Tobacco Plan ready by the Ministry of Well being.
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Janssen is pushing for approval of lazertinib together with ▼RYBREVANT® towards NSCLC with EGFR mutation
The request is supported by knowledge from the part 3 MARIPOSA examine that was introduced in a presidential session as a late abstract on the ESMO 2023 convention.
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EMA recommends approval of sotatercept for sufferers with PAH
The therapy, beforehand designated as Precedence Drugs and orphan medication by the EMA for PAH, might be assessed by the EC following a CHMP suggestion. A call on advertising and marketing authorization within the European Union, Iceland, Liechtenstein and Norway is anticipated within the third quarter of 2024.
Argenx Broadcasts VYVGART Pricing and Reimbursement Settlement® for myasthenia gravis in adults
The funding resolution marks the primary historic milestone for argenx, an immunology-focused firm dedicated to bettering the lives of individuals with extreme autoimmune illnesses.
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Janssen is making use of for ▼RYBREVANT approval® earlier than CPNM
The sort II modification of sign amplification is supported by knowledge from PAPILLON, the primary randomized part 3 examine in sufferers with non-small cell lung most cancers (NSCLC) with EGFR exon 20 insertion mutations.
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2024-07-12 09:15:00
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