Drug Topics

SEPTEMBER 3, 2024

The protein-based vaccine includes a monovalent component corresponding to the Omicron variant JN.1 1 strain.

Vaccines 407

Vaccines FDA 407

Drug Topics

FEBRUARY 24, 2023

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

Vaccines 468

Vaccines FDA 468

Drug Topics

JANUARY 18, 2024

In 2023, the FDA approved six vaccines, including 2 for respiratory syncytial virus (RSV), and the first vaccine to prevent the mosquito-borne virus chikungunya.

Vaccines 469

Vaccines FDA 469

Drug Topics

FEBRUARY 15, 2024

Innovation in the vaccine area continues. In 2023, the FDA approved six vaccines, including several important firsts. But they face a difficult landscape where federal policies dictate coverage.

Vaccines 461

Vaccines Insurance FDA 461

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 464

Vaccines FDA 464

Drug Topics

JUNE 21, 2023

The first RSV vaccines were approved by the FDA earlier this year.

Vaccines 468

Vaccines FDA 468

Drug Topics

APRIL 28, 2023

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

Vaccines 467

Vaccines FDA 467

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 446

Vaccines FDA 446

Drug Topics

APRIL 18, 2023

Monovalent vaccines by these manufacturers are no longer authorized for use in the United States.

Vaccines 469

Vaccines FDA 469

Drug Topics

JANUARY 27, 2023

Recommendations from the unanimous vote must be adopted by the FDA and CDC.

FDA 467

FDA Vaccines 467

STAT

FEBRUARY 26, 2025

The Food and Drug Administration canceled an upcoming vaccine advisory committee meeting to discuss influenza virus strains, according to committee member Paul Offit.  “Vaccine makers look to this meeting to determine which strains to include in this year’s vaccine.”

Vaccines 145

Vaccines FDA 145

Drug Topics

AUGUST 2, 2024

The technology from Diakonos Oncology initiates a natural immune response that targets and eliminates cancer cells by activating cytotoxic TH1 cell signaling pathways.

Immunization 526

Immunization Vaccines FDA 526

Drug Topics

JUNE 7, 2024

Check out important updates from the FDA for the week of June 3.

FDA 359

FDA Vaccines 359

Drug Topics

APRIL 16, 2024

The company’s investigational ABCWY vaccine candidate will be reviewed by the FDA by February 14, 2025.

Vaccines 247

Vaccines FDA 247

Drug Topics

MAY 10, 2024

The federal agency said the delay was due to administrative constraints and did not cite any vaccine safety, efficacy or quality issues.

Vaccines 281

Vaccines FDA 281

Drug Topics

MAY 31, 2024

mRESVIA is the first mRNA vaccine approved for a disease other than COVID-19.

Vaccines 281

Vaccines FDA 281

Drug Topics

JUNE 16, 2023

The VRBPAC committee voted 21-0 in favor of this recommendation.

Vaccines 465

Vaccines FDA 465

Drug Topics

JANUARY 8, 2025

Patients who receive either Pfizer or GSKs respiratory syncytial virus vaccine may be at increased risk of Guillain-Barr syndrome.

Vaccines 307

Vaccines Labelling FDA 307

Drug Topics

FEBRUARY 17, 2025

The vaccine is the first virus-like particle single-dose vaccine for chikungunya for patients 12 years and older.

Vaccines 242

Vaccines FDA 242

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 247

Vaccines FDA 247

Drug Topics

NOVEMBER 10, 2023

Ixchiq was approved through the FDA Accelerated Approval pathway.

FDA 281

FDA Vaccines 281

Drug Topics

AUGUST 16, 2023

PXVX0317 has received Fast Track and Breakthrough Therapy designation from the FDA.

Vaccines 468

Vaccines FDA 468

Pharmafile

MARCH 28, 2025

The US Food and Drug Association (FDA) has granted fast track designation to Sanofis mRNA vaccine candidate for the prevention of chlamydia infection. The chlamydia vaccine candidate has been designed to protect against primary genital tract infection and reinfection caused by the bacterium Chlamydia trachomatis.

Vaccines 69

Vaccines FDA 69

Drug Topics

SEPTEMBER 25, 2024

Catch up on important immunization news from the month of September.

Immunization 375

Immunization Vaccines FDA 375

Drug Topics

SEPTEMBER 20, 2024

The vaccine will be made available via third-party online pharmacies.

Vaccines 247

Vaccines FDA 247

Drug Topics

JUNE 23, 2023

vaccine, the company said that doses would be available in time for fall vaccination. Pending authorization of the XBB.1.5

Vaccines 247

Vaccines FDA 247

Drug Topics

APRIL 26, 2023

Two RSV vaccines for seniors have completed phase 3 trials and demonstrated beneficial results. The public still awaits FDA decisions on potential approvals for both.

Vaccines 247

Vaccines FDA 247

Drug Topics

OCTOBER 17, 2024

Three RSV vaccines are currently FDA approved for use in adults aged 60 or older.

Vaccines 247

Vaccines FDA 247

Drug Topics

MARCH 28, 2025

Currently, there is no vaccine to prevent chlamydia, but treatment includes regimens of antibiotics, including doxycycline, azithromycin, and levofloxacin.

Vaccines 190

Vaccines FDA 190

Drug Topics

JUNE 21, 2024

Check out important updates from the FDA for the week of June 17.

FDA 216

FDA Vaccines 216

Drug Topics

MARCH 15, 2023

A new booster shot of the Pfizer-BioNTech COVID-19 vaccine is now available for children aged 6 months to 4 years, in an effort to continue to curb the effects of COVID-19

Vaccines 247

Vaccines FDA 247

Drug Topics

OCTOBER 23, 2024

Abrysvo is the only RSV vaccine approved for use in this age group.

Vaccines 307

Vaccines FDA 307

Drug Topics

AUGUST 23, 2024

Check out important updates from the FDA for the week of August 19.

FDA 216

FDA Vaccines 216

Pharmaceutical Technology

JUNE 17, 2024

Novavax has sought US FDA approval for an updated JN.1 1 version of its Covid-19 vaccine, NVX-CoV2705, for individuals aged 12 years and above.

Vaccines 145

Vaccines FDA 145

STAT

OCTOBER 3, 2023

The Food and Drug Administration on Tuesday authorized Novavax’s updated Covid-19 vaccine, giving Americans seeking to update their protection against the SARS-CoV-2 virus another option. based company, which has struggled to claim a share of the now dwindling Covid vaccine market — globally and within the United States.

Vaccines 145

Vaccines FDA 145

STAT

JUNE 7, 2024

The Food and Drug Administration on Friday expanded the approval for GSK’s vaccine to protect against respiratory syncytial virus, or RSV, authorizing its use for at-risk adults as young as 50. Arexvy, which was the first RSV vaccine approved , now becomes the first to be available to adults under the age of 60 who are not pregnant.

Vaccines 143

Vaccines FDA 143

STAT

SEPTEMBER 11, 2023

The Food and Drug Administration announced Monday that it had greenlit two   updated Covid-19 booster shots in people as young as 6 months old, triggering a process that could see the Moderna and Pfizer-BioNTech vaccines become available in doctors’ offices, clinics, and pharmacies later this week. Read the rest…

Vaccines 145

Vaccines FDA 145