Pharmaceutical Technology

SEPTEMBER 23, 2024

The US FDA has granted approval for AstraZeneca's FluMist, a needle-free nasal spray influenza vaccine for self-administration.

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FDA Approval Vaccination Vaccine 264

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.

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FDA Approval Vaccination Vaccine 278

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.

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FDA Approval Vaccination Vaccine 246

Bio Pharma Dive

MAY 3, 2023

The decision represents the first fruits of a scientific breakthrough a decade ago that gave drugmakers, among them GSK, Pfizer and Moderna, a blueprint for an effective shot against the virus.

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FDA Approval Vaccination Vaccine 356

Bio Pharma Dive

MARCH 29, 2021

A long-awaited reckoning for Biogen’s Alzheimer’s drug and the review of AstraZeneca’s coronavirus vaccine are among the top FDA decisions expected before the end of June.

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FDA Approval Vaccination Vaccine Drugs 361

Bio Pharma Dive

SEPTEMBER 29, 2020

The world's attention will be on the FDA as it considers initial data from coronavirus vaccine developers. But several other important drugs, including a CAR-T therapy and an Ebola antibody, will also be on the agency's agenda.

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FDA Approval Antibody Vaccination Vaccine 353

Bio Pharma Dive

SEPTEMBER 11, 2023

Pfizer and Moderna, which have seen slowing demand for their coronavirus vaccines, expect to make the reformulated shots available in the U.S. in the coming days.

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FDA Approval Vaccination Vaccine 315

Bio Pharma Dive

OCTOBER 1, 2021

Regulators face key decisions on COVID-19 shots for children and boosters for Moderna's and J&J's vaccines. Other closely watched drugs for multiple myeloma and depression are under review, too.

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FDA Approval Regulation Vaccination Vaccine 330

XTalks

NOVEMBER 15, 2024

Pfizer released a new respiratory syncytial virus (RSV) vaccine TV commercial, titled “Your Moments Are Worth Protecting: Celebration” as part of its ongoing campaign to raise awareness about the importance of vaccination against RSV. Moderna entered the RSV vaccine arena this year with the very first mRNA-based RSV vaccine.

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Vaccination Vaccine Gene Therapy RNA 105

Pharmaceutical Technology

SEPTEMBER 15, 2022

Last year was a positive year for biopharmaceutical companies, particularly those with Covid-19 vaccines. As a result of huge global sales of mRNA Covid-19 vaccines, the split in profits between Pfizer and BioNTech’s Comirnaty contributed towards revenues of $81.3bn and $22.4bn last year, respectively. YoY revenue growth.

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Vaccination Vaccine Sales Generic Drugs 272

Bio Pharma Dive

JULY 11, 2023

While the shot is approved in the EU, Takeda wasn’t able to address data collection issues raised by the US regulator in its current review cycle.

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FDA Approval Vaccination Vaccine Regulation 246

Bio Pharma Dive

AUGUST 21, 2023

The expanded approval follows the FDA’s May clearance of the shot, called Abrysvo, in older adults.

FDA Approval 246

FDA Approval Vaccination Vaccine 246

Pharmaceutical Technology

OCTOBER 10, 2022

The US Food and Drug Administration (FDA) has approved GlaxoSmithKline ’s (GSK) Boostrix (tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine adsorbed [Tdap]) for pregnant women during their third trimester to prevent pertussis (whooping cough) in newborn infants.

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FDA Approval Vaccination Vaccine Antibody 147

Pharmaceutical Technology

FEBRUARY 17, 2025

GSK has secured approval from the FD for its new vaccine, Penmenvy, to protect against five meningococcal serogroups.

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FDA Approval Vaccination Vaccine 147

Pharmaceutical Technology

JUNE 10, 2024

The US FDA approved GSK's Arexvy, an RSV vaccine for adults aged 50 to 59 years at higher lower respiratory tract disease (LRTD) risk.

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FDA Approval Vaccination Vaccine 130

Pharmaceutical Technology

AUGUST 23, 2024

The US FDA has approved and granted EUA for Moderna and Pfizer-BioNTech’s updated mRNA Covid-19 vaccines, Comirnaty and Spikevax.

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FDA Approval Vaccination Vaccine 147

Pharma Times

SEPTEMBER 18, 2023

The updated vaccines more closely target current circulating variants - News - PharmaTimes

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FDA Approval Vaccination Vaccine 168

Pharmaceutical Technology

APRIL 1, 2025

The formulation allows for greater stockpiling, with Bavarian Nordic already working with the US government to add to vaccine reserves.

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FDA Approval Vaccination Vaccine 130

Bio Pharma Dive

JUNE 30, 2022

But the drug may not meaningfully help people who are vaccinated, and concerns about its potency against emerging variants are growing. Converting Paxlovid’s emergency authorization to a standard clearance could further broaden its use.

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FDA Approval Vaccination Vaccine Drugs 270

Pharmaceutical Technology

NOVEMBER 10, 2023

Following the three-month FDA review delay, Valneva’s live-attenuated chikungunya vaccine, Ixchiq received accelerated approval.

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FDA Approval Vaccination Vaccine 147

Bio Pharma Dive

FEBRUARY 19, 2021

Testing showed the vaccine could be safely stored at normal freezer temperatures, rather than the roughly minus 70 degrees Celsius now specified. The change, if cleared by the agency, will help distribution.

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FDA Approval Vaccination Vaccine 241

Pharmaceutical Technology

AUGUST 30, 2024

Emergent BioSolutions has received FDA approval for ACAM2000 to expand its use for the prevention of Mpox.

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FDA Approval Vaccination Vaccine 130

Bio Pharma Dive

SEPTEMBER 9, 2020

Results from two Phase 3 studies put Merck in position to ask for FDA approval of its shot later this year. Pfizer may not be far behind with a rival product.

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FDA Approval Vaccination Vaccine Production 225

XTalks

JANUARY 22, 2025

Valneva SE, who developed the worlds first FDA-approved chikungunya vaccine , has now unveiled promising Phase III data for its single-shot chikungunya vaccine, IXCHIQ, in adolescents aged 12 to 17. The VLA1553-321 trial, conducted in Brazil, was the first to assess the vaccine in an endemic region.

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Immune Response Vaccination Vaccine Trials 59

XTalks

JUNE 21, 2024

The US Food and Drug Administration (FDA) has green-lighted the first pneumonia vaccine specifically designed for adults 50 years of age and older. These numbers do not reflect the efficacies of the vaccines, which have not been compared head-to-head in any trial yet.

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FDA Approval Vaccination Vaccine Life Science 108

XTalks

DECEMBER 7, 2021

VBI Vaccines got its first vaccine approval from the US Food and Drug Administration (FDA) for its hepatitis B shot PreHevbrio. PreHevbrio is approved for the prevention of hepatitis B infection caused by the hepatitis B virus (HBV) in adults 18 years of age and older.

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FDA Approval Vaccination Vaccine Marketing 103

pharmaphorum

MAY 31, 2024

Moderna has secured FDA approval for its RSV vaccine, setting up a three-way market battle with GSK and Pfizer.

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Vaccination Vaccine FDA Approval Marketing 119

Pharmaceutical Technology

OCTOBER 28, 2022

On 24 October, American vaccine developer Vaxcyte shared positive topline data from a Phase I/II study of its multivalent conjugate pneumococcal vaccine VAX-24 , bringing the 24-valent pneumococcal jab one step closer to market. This is in addition to its long-available pneumococcal polysaccharide vaccine PPSV23.

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Vaccination Vaccine Marketing Bacteria 162

XTalks

JULY 25, 2023

Emergent BioSolutions, a multinational specialty biopharmaceutical company headquartered in Gaithersburg, Maryland, has achieved a significant milestone with the approval of its Cyfendus (Anthrax Vaccine Adsorbed, Adjuvanted) vaccine by the US Food and Drug Administration (FDA). How Does Cyfendus Work?

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FDA Approval Vaccination Vaccine Antibody 98

Pharmaceutical Technology

FEBRUARY 1, 2023

RSV researchers at major pharmaceutical companies are currently working to develop new RSV drugs to beat future waves of RSV infection and gain the first RSV vaccine FDA approval. Pharmaceutical companies are pushing to develop drugs and vaccines for RSV with these populations in mind. per 100,000.

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Vaccination Vaccine Antibody Development 162

Pharmaceutical Technology

APRIL 28, 2023

The US Food and Drug Administration (FDA) has approved Pfizer’s 20-valent pneumococcal conjugate vaccine, PREVNAR 20 , to prevent invasive pneumococcal disease (IPD) in infants and children aged six weeks to 17 years. PREVNAR 20 has been developed on the basis of Pfizer’s approved PREVNAR 13 vaccine.

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Vaccination Vaccine FDA Approval Trials 147

XTalks

JULY 28, 2021

Merck has scored US Food and Drug Administration (FDA) approval for its next-generation pneumonia vaccine Vaxneuvance that covers 15 different strains of the pneumococcal bacteria that causes the infection. This is seven more strains than its current winning vaccine Prevnar 13, which registered $5.95

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FDA Approval Vaccination Vaccine Immune Response 89

Fierce Pharma

JUNE 17, 2024

The FDA has approved the world’s first pneumococcal disease vaccine designed for adults, signing off on Merck’s Capvaxive (formerly V116) and positioning it to become the primary shot used by senio | The FDA has approved the world’s first pneumococcal disease vaccine designed for adults, signing off on Merck’s Capvaxive (formerly V116) and positioning (..)

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Vaccination Vaccine FDA Approval 116

Bio Pharma Dive

JANUARY 18, 2023

Moderna plans to follow those companies in asking for FDA approval. The biotech’s results appear competitive to past data for RSV shots being developed by GSK and Pfizer.

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FDA Approval Vaccination Vaccine Development 180

BioSpace

MAY 6, 2021

FDA for COVID-19 vaccines, Pfizer/BioNTech and Moderna are planning to seek full approval for the preventative medications. Six months after receiving Emergency Use Authorization from the U.S.

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FDA Approval Vaccination Vaccine 117

pharmaphorum

AUGUST 30, 2024

Emergent BioSolutions has been given FDA approval to extend the indications for its smallpox vaccine ACAM2000 to include the prevention of mpox, currently deemed a public health emergency by the WHO.

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Vaccination Vaccine FDA Approval 108

BioSpace

JUNE 21, 2022

On Wednesday, the FDA approved Merck's pneumococcal 15-valent conjugate vaccine for children 6 weeks through 17 years of age.

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FDA Approval Vaccination Vaccine 83