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Moderna, Inc.: Moderna Announces European Medicines Agency Authorizes Third Dose of COVID-19 Vaccine for Immunocompromised Individuals Aged 12 Years and Older

Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines today announced that the European Medicines Agency (EMA) has authorized a third dose
Lavina Talukdar Colleen Hussey Centers For Disease World Health Organization European Commission Exchange Commission

Pfizer and BioNTech Receive First Authorization in European

BioNTech SE (Nasdaq: BNTX) today announced that the Conditional Marketing Authorization (CMA) for COMIRNATY ® in the European Union (EU) has been expanded to include individuals 12 to 15 years of age. This follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion to authorize the vaccine in this age group. The extended indication for the CMA for COMIRNATY ® is valid in all 27 EU member states. COMIRNATY ® was the first COVID-19 vac...
United States United Kingdom Albert Bourla Ugur Sahin European Commission Drug Administration

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Investegate |BioNTech SE Announcements | BioNTech SE: Pfizer and BioNTech to Supply the European Union with up to 1.8 Billion Additional Doses of COMIRNATY®

BioNTech SE Pfizer and BioNTech to Supply the European Union with up to 1.8 Billion Additional Doses of COMIRNATY® Pfizer and BioNTech to Supply the European Union with up to 1.8 Billion Additional Doses of COMIRNATY® New agreement to supply 900 million doses to the European Commission (EC), with option to request up to an additional 900 million doses Additional dose deliveries beginning December 2021 through 2023 Pfizer and BioNTech have now committed a total of up to 2.4 billion doses of C...
United States United Kingdom Sylke Maas Albert Bourla Chuck Triano Andrew Widger

BioNTech SE: Pfizer and BioNTech Submit Request to Expand Conditional Marketing Authorization of COMIRNATY in the EU to Adolescents

BioNTech SE: Pfizer and BioNTech Submit Request to Expand Conditional Marketing Authorization of COMIRNATY in the EU to Adolescents 1 (Nasdaq: BNTX) today announced they have submitted a variation to the Conditional Marketing Authorization (CMA) in the European Union (EU) to the European Medicines Agency (EMA) for the Pfizer-BioNTech vaccine COMIRNATY (BNT162b2) to request an extension of the indication for use in adolescents 12 to 15 years of age. If EMA approves the variation, the amended CM...
United States United Kingdom Sylke Maas Andy Widger Chuck Triano Fosun Pharma

Johnson & Johnson Single-Shot COVID-19 Vaccine Phase 3 Data Published in New England Journal of Medicine

Search jobs Johnson & Johnson Single-Shot COVID-19 Vaccine Phase 3 Data Published in New England Journal of Medicine NEW BRUNSWICK, N.J., April 21, 2021 – Johnson & Johnson (the Company) today announced publication in the New England Journal of Medicine of primary data from the Phase 3 ENSEMBLE clinical trial for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen). The publication of the primary analys...
United States South Africa South African Paul Stoffels Mathai Mammen Pharmacovigilance Risk Assessment Committee

Johnson & Johnson COVID-19 Vaccine Roll-out to Resume in Europe Following European Medicines Agency (EMA) Review | More News

Hits: 143 EMA Confirms Overall Benefit-Risk Profile Remains Positive Company to update the COVID-19 Vaccine Janssen Summary of Product Characteristics and Package Leaflet to include important information on very rare adverse event Johnson & Johnson remains committed to supplying 200 million doses of its COVID-19 vaccine to the European Union, Norway and Iceland NEW BRUNSWICK, NJ, USA I April 20, 2021 I Johnson & Johnson (NYSE: JNJ) (the Company) today announced that the European Medicines A...
Paul Stoffels Qi Johnson Pharmacovigilance Risk Assessment Committee Us Centers For Disease European Commission Drug Administration

EMA finds overall benefit-risk 'remains positive' for J&J COVID-19 vaccine

EMA finds overall benefit-risk ‘remains positive’ for J&J COVID-19 vaccine Safety committee finds possible link to ‘very rare cases’ of unusual blood blots with low blood platelets The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has confirmed that the overall benefit-risk profile of Johnson & Johnson’s (J&J) COVID-19 vaccine is positive. The PRAC concluded in a meeting yesterday, however, that a warning regarding unusual blood clots with lo...
Paul Stoffels Pharmacovigilance Risk Assessment Committee Astrazeneca Oxford University European Medicines Agency Us Centers For Disease Advisory Committee On Immunization Practices
Source: pmlive.com

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