The Pharma Data

MARCH 2, 2021

The Company plans to file for a Biologics License Application (BLA) with the FDA later in 2021. The Janssen COVID-19 vaccine has not been approved or licensed by the U.S. There is no FDA-approved vaccine to prevent COVID-19. The terms of the EUA allow use of the vaccine while more data are gathered.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

MARCH 4, 2021

Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Dupixent ® (dupilumab) as an add-on treatment for children aged 6 to 11 years with uncontrolled moderate-to-severe asthma.

Genetics 52

Genetics Medicine Antibody Trials 52

Pharmaceutical Technology

JUNE 9, 2023

Although AdCom verdicts are considered by the FDA when it comes to approvals, they are not binding. The FDA accepted nirsevimab’s biologics license application (BLA) in January, with a PDUFA date penned for Q3 2023.

FDA Approval 147

FDA Approval Antibody Allergies Packaging 147

The Pharma Data

JULY 29, 2021

Baricitinib is an oral JAK inhibitor discovered by Incyte and licensed to Lilly. See Warnings and Precautions in the FDA-approved full Prescribing Information and Medication Guide for additional information on risks associated with longer-term treatment with baricitinib. It is approved in the U.S. Serious Side Effects.

HR 52

HR Licensing Licensing FDA Approval 52

The Pharma Data

FEBRUARY 13, 2022

If approved, Dupixent will be the first biologic medicine available in the U.S. to treat uncontrolled moderate-to-severe atopic dermatitis for these young children. About Regeneron Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases.

Medicine 40

Medicine Genetics Antibody Allergies 40

The Pharma Data

MAY 4, 2021

See Warnings and Precautions in the FDA-approved full Prescribing Information for additional information on risks associated with longer-term treatment with baricitinib. About OLUMIANT ® (baricitinib) OLUMIANT, a once-daily, oral JAK inhibitor was discovered by Incyte and licensed to Lilly. It is approved in the U.S.

Antibody 52

Antibody Medicine FDA Approval Licensing 52

The Pharma Data

DECEMBER 8, 2020

and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Source: Moderna, Inc. .

Vaccination 40

Vaccination Vaccine Manufacturing Containment 40

The Pharma Data

AUGUST 17, 2021

Do not take Lyumjev or Humalog if you have: symptoms of low blood sugar (hypoglycemia) an allergy to insulin lispro-aabc, Humalog, or any of the ingredients in Lyumjev or Humalog. Lyumjev ® and Humalog ® are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

Insulin 52

Insulin FDA Approval Doctors Doctor 52

XTalks

AUGUST 2, 2023

Paxlovid was first authorized under the FDA Emergency Use Authorization in December 2021 ; however, it has received FDA approval on May 25, 2023. pneumoniae serotypes) replaced the company’s first pneumococcal conjugate vaccine Prevnar (PCV7, approved by the FDA in February 2000) in a February 2010 FDA approval.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

Pfizer

JULY 26, 2022

a second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine. a second booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine.

Vaccination 111

Vaccination Vaccine Protein Immune Response 111

Pfizer

JANUARY 27, 2023

COMIRNATY® (COVID-19 Vaccine, mRNA) INDICATION COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.

Research 112

Research Vaccination Vaccine Drugs 112

The Pharma Data

APRIL 8, 2021

The COV-BARRIER trial was designed to complement the Adaptive COVID-19 Treatment Trial (ACTT-2) sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). Baricitinib, an oral JAK inhibitor, was discovered by Incyte and licensed to Lilly. Warnings and Precautions ?in

FDA Approval 52

FDA Approval HR Trials Medicine 52

Pfizer

JULY 19, 2022

a second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine. a second booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine.

Vaccination 100

Vaccination Vaccine Medicine Clinical Trials 100

Pfizer

JULY 8, 2022

a second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine. a second booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine.

Vaccination 81

Vaccination Vaccine Clinical Trials Clinical Trials 81

The Pharma Data

NOVEMBER 4, 2020

In addition, Amarin recognized licensing and royalty revenue of approximately $1.3 This compares with licensing and royalty revenue of $0.2 It is not known whether patients with allergies to fish and/or shellfish are at an increased risk of an allergic reaction to VASCEPA. Licensing and royalty revenue.

Sales 40

Sales Production Cardiology Marketing 40

The Pharma Data

JULY 12, 2021

EUA Statement on All Materials: The Janssen COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized by FDA through an Emergency Use Authorization (EUA) for active immunization to prevent Coronavirus Disease 2019 (COVID-19) in individuals 18 years of age and older.

Vaccination 52

Vaccination Vaccine FDA Approval Allergies 52

The Pharma Data

APRIL 27, 2021

At the end of March, the FDA approved Sarclisa ® in combination with carfilzomib and dexamethasone for patients with relapsed multiple myeloma. Developed as part of a joint-partnership between Sanofi and Merck, Vaxelis ® is the first and only hexavalent combination vaccine approved in the U.S. First-quarter sales in the U.S.

Sales 52

Sales Vaccination Vaccine Medicine 52

The Pharma Data

JANUARY 26, 2021

Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. Bamlanivimab FDA Approval History. It was identified from a blood sample taken from one of the first U.S.

Antibody 52

Antibody Trials Clinical Trials Clinical Trials 52

The Pharma Data

NOVEMBER 30, 2020

Food and Drug Administration (FDA) and conditional approval from the European Medicines Agency (EMA). MRNA-1273 (SARS-CoV-2 vaccine) FDA Approval History. The Phase 3 study, known as the COVE study, enrolled more than 30,000 participants in the U.S. Source: Moderna, Inc. . Posted: November 2020. Source link.

Vaccination 52

Vaccination Vaccine Medicine Clinical Trials 52

Pfizer

NOVEMBER 2, 2022

*Monovalent refers to any authorized and approved COVID-19 vaccine that contains or encodes the spike protein of only the Original SARS-CoV-2 virus. Pfizer-BioNTech COVID-19 Vaccine is FDA authorized under Emergency Use Authorization (EUA) for use in individuals 6 months and older to provide: Primary Series. INDICATION. have a fever.

Vaccination 85

Vaccination Vaccine Clinical Trials Clinical Trials 85

Pfizer

DECEMBER 8, 2022

*Monovalent refers to any authorized and approved COVID-19 vaccine that contains or encodes the spike protein of only the Original SARS-CoV-2 virus. . Tell your vaccination provider about all of your medical conditions, including if you: have any allergies. COMIRNATY® (COVID-19 Vaccine, mRNA). INDICATION. EMERGENCY USE AUTHORIZATION.

Vaccination 81

Vaccination Vaccine Clinical Trials Clinical Trials 81