Pharmacy Times

SEPTEMBER 11, 2023

FDA grants updated Moderna and Pfizer-BioNTech COVID-19 vaccines with emergency use authorization to target currently circulating variants of the virus.

Vaccines 149

Vaccines FDA 149

STAT

OCTOBER 5, 2023

The Food and Drug Administration’s expert vaccine advisory panel on Thursday unanimously endorsed the idea of taking a strain of influenza viruses that no longer appears to circulate out of flu shots as quickly as possible, pressing the FDA and manufacturers to try to get the work done on an expedited timeline.

Vaccines 144

Vaccines FDA 144

Drug Topics

NOVEMBER 10, 2023

Ixchiq contains a live, weakened version of the chikungunya virus and may cause symptoms in the vaccine recipient similar to those experienced by people who have chikungunya disease.

Vaccines 185

Vaccines FDA 185

Drug Topics

JANUARY 18, 2023

The FDA has approved another Tdap vaccine option for use during pregnancy to prevent pertussis, otherwise known as whooping cough.

Vaccines 187

Vaccines FDA 187

Drug Topics

NOVEMBER 7, 2023

The FDA is advising health care professionals who administer the vaccine to make sure the correct volume of the vaccine is withdrawn from the vial and the correct dose is administered to the patient.

Vaccines 98

Vaccines FDA 98

Drug Topics

JUNE 1, 2023

Abrysvo is the second RSV vaccine approved by the FDA.

Vaccines 187

Vaccines FDA 187

Drug Topics

SEPTEMBER 11, 2023

Bivalent COVID-19 vaccines by both Moderna and Pfizer-BioNTech are no longer authorized for use in the United States.

Vaccines 209

Vaccines FDA 209

pharmaphorum

NOVEMBER 10, 2023

First chikungunya vaccine approved by FDA Phil.Taylor Fri, 10/11/2023 - 08:37 Bookmark this

Vaccines 97

Vaccines FDA 97

pharmaphorum

APRIL 16, 2024

FDA starts review of GSK’s 5-in-1 meningitis vaccine, cueing up a decision early next year, as it tries to chase down Pfizer's recently-approved Penbraya

Vaccines 110

Vaccines FDA 110

Fierce Pharma

SEPTEMBER 11, 2023

The FDA has approved Pfizer and Moderna’s separate vaccine formulations that target current variants of the disease. Out with the old and in with the new: Monday, the U.S. | Each company’s shot is approved for people ages 12 and up and emergency authorized for patients 6 months old to 11 years old.

Vaccines 143

Vaccines FDA 143

Pharmacy Times

APRIL 15, 2024

Although the vaccine has not yet been tested in humans, it demonstrated 100% efficacy in protecting primates who were injected with human Marburg virus disease.

Vaccines 107

Vaccines FDA 107

Drug Topics

MAY 3, 2023

The vaccine is approved for use in adults aged 60 and older to prevent lower respiratory tract disease caused by RSV.

Vaccines 187

Vaccines FDA 187

Fierce Pharma

NOVEMBER 10, 2023

The FDA has approved the world’s first chikungunya vaccine, giving a thumbs-up to Valneva’s Ixchiq. The French company receives a priority review voucher from the FDA, which it said it will sell. Valneva has won the race in the U.S. | It is an accelerated approval and subject to a confirmatory, real-world study.

Vaccines 99

Vaccines FDA 99

Pharmacy Times

AUGUST 10, 2023

Approximately 57% of individuals who were shown a flowchart of the FDA vaccine approval process were very or somewhat likely to recommend a respiratory syncytial virus vaccine to a pregnant family member or friend compared to only 40% of those who were not shown the process.

Vaccines 122

Vaccines Communication FDA 122

Drug Topics

AUGUST 22, 2023

The respiratory syncytial virus vaccine (Abrysvo) is the first and only maternal RSV vaccine used to help protect infants from the virus.

Vaccines 178

Vaccines FDA 178

STAT

MAY 31, 2023

The Food and Drug Administration approved a second vaccine to protect older adults against RSV on Wednesday, giving a green light to Pfizer’s Abrysvo for adults 60 and older. Early in May the FDA approved the first ever vaccine against respiratory syncytial virus, or RSV, when it licensed GSK’s Arexvy.

Vaccines 103

Vaccines FDA 103

Pharmaceutical Technology

SEPTEMBER 12, 2023

The US FDA has approved Pfizer and BioNTech’s sBLA for Omicron XBB.1.5-adapted adapted monovalent Covid-19 vaccine, COMIRNATY 2023-2024 Formulation.

Vaccines 111

Vaccines FDA 111

Pharmacy Times

APRIL 16, 2024

The 5-in-1 meningococcal ABCWY vaccine candidate has an assigned Prescription Drug User Fee Act action date of February 14, 2025.

Vaccines 94

Vaccines FDA 94

Fierce Pharma

APRIL 19, 2023

Goodbye, original COVID-19 vaccines: FDA updates shot guidance, pulls monovalent authorizations zbecker Wed, 04/19/2023 - 11:04

Vaccines 145

Vaccines FDA 145

pharmaphorum

OCTOBER 24, 2023

AZ seeks FDA okay for first self-administered flu vaccine Phil.Taylor Tue, 24/10/2023 - 10:19 Bookmark this

Vaccines 107

Vaccines FDA 107

Pharmacy Times

AUGUST 22, 2023

It is the first vaccine of its kind to be FDA approved, and it met multiple safety and efficacy standards through clinical trials.

Vaccines 123

Vaccines FDA 123

Pharmafile

MARCH 2, 2023

Yesterday, GSK shared that an advisory committee from the FDA voted in support of its respiratory syncytial virus (RSV) vaccine candidate for older adults. This support is ahead of an official FDA approval for the company’s vaccine. GSK has shared that a final decision is expected to be made by the FDA ahead of the 3 May.

Vaccines 98

Vaccines FDA Communication 98

pharmaphorum

NOVEMBER 23, 2022

The US regulator has started a priority, six-month review of Takeda’s dengue fever vaccine TAK-003 – tipped as a potential blockbuster product – making a decision likely in the first half of 2023. The vaccine has already been approved as Qdenga in Indonesia – where the disease is endemic – to protect people in the six to 45 age bracket.

Vaccines 122

Vaccines FDA 122

Fierce Pharma

OCTOBER 24, 2023

On the market for two decades, AstraZeneca’s nasal spray flu vaccine, FluMist, may become available for self-administration as soon as next year. | On the market for two decades, AstraZeneca’s nasal spray flu vaccine, FluMist, may become available for self-administration as soon as next year.

Vaccines 107

Vaccines FDA 107

Pharmaceutical Technology

AUGUST 4, 2023

The US FDA has granted approval for an expanded indication of Merck’s Ebola vaccine, Ervebo, for usage in the paediatric population.

Vaccines 98

Vaccines FDA 98

Pharmacy Times

FEBRUARY 12, 2024

The updated indication for the respiratory syncytial virus vaccine is for adults aged 50 to 59 with underlying conditions who are at an increased risk of contracting the virus.

Vaccines 132

Vaccines FDA 132

Drug Topics

APRIL 28, 2023

Prevnar 20 contains 20 serotypes and grants the broadest serotype coverage of any pediatric pneumococcal conjugate vaccine.

Vaccines 186

Vaccines FDA 186

pharmaphorum

JUNE 27, 2023

FDA fast-tracks GSK’s gonorrhoea vaccine Phil.Taylor Wed, 28/06/2023 - 06:04 Bookmark this

Vaccines 95

Vaccines FDA 95

pharmaphorum

JULY 12, 2023

Takeda pulls its dengue vaccine filing from FDA Phil.Taylor Wed, 12/07/2023 - 07:16 Bookmark this

Vaccines 95

Vaccines FDA 95

Fierce Pharma

MARCH 4, 2024

After decades of research into respiratory syncytial virus (RSV), Pfizer and GSK’s groundbreaking vaccines made waves as the first immunizations against the common respiratory illness.

Vaccines 106

Vaccines Immunization FDA 106

Fierce Pharma

OCTOBER 25, 2023

Five months after becoming the first company to secure FDA approval for a respiratory syncytial virus (RSV) vaccine, GSK is taking steps toward expanding its label for Arexvy. The FDA has already endorsed it for people 60 and older. The results could pave the way for the shot to be approved for this age group.

Labelling 88

Labelling Vaccines FDA 88

pharmaphorum

JUNE 13, 2023

Valneva preps for FDA verdict on chikungunya vaccine Phil.Taylor Tue, 13/06/2023 - 14:27 Bookmark this

Vaccines 95

Vaccines FDA 95

pharmaphorum

AUGUST 22, 2023

FDA clears Pfizer's Abrysvo as first maternal RSV vaccine Phil.Taylor Tue, 22/08/2023 - 09:58 Bookmark this

Vaccines 78

Vaccines FDA 78

Pharmacy Times

OCTOBER 20, 2023

Penbraya (Pfizer Inc) is the first and only approved pentavalent vaccine that confers protection against the most common meningococcal serogroups—A, B, C, W-135, and Y, in individuals 10 through 25 years of age.

Vaccines 145

Vaccines FDA 145

Fierce Healthcare

JANUARY 27, 2023

FDA panel approves path toward one-shot yearly COVID vaccine fdiamond Fri, 01/27/2023 - 09:17

Vaccines 127

Vaccines FDA 127

Drug Topics

FEBRUARY 24, 2023

The vaccine would be administered to pregnant people to protect newborns from RSV.

Vaccines 187

Vaccines FDA 187

STAT

JULY 11, 2023

Takeda announced Tuesday that it has voluntarily withdrawn its application to the Food and Drug Administration for its dengue vaccine, making it unclear when or if the vaccine will be licensed in this country. The company said in a press release that it will review whether to proceed with trying to bring the vaccine to the U.S.

Vaccines 98

Vaccines FDA 98