Novavax seeks FDA approval for updated Covid-19 vaccine
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.
WestGene wins FDA approval for mRNA vaccine to treat certain cancers
Pharmaceutical Technology
MAY 10, 2024
The FDA approved WestGene’s mRNA therapeutic cancer vaccine as mRNA cancer vaccine development rises in popularity.
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Pfizer wins FDA approval of new meningococcal vaccine
Bio Pharma Dive
OCTOBER 23, 2023
The clearance of the pentavalent shot Penbraya adds to Pfizer’s infectious disease portfolio as it adjusts to slumping COVID-19 vaccine sales.
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Pfizer’s RSV vaccine wins FDA approval in older adults
Bio Pharma Dive
MAY 31, 2023
The shot’s clearance comes several weeks after the regulator made GSK’s Arexvy the first vaccine for RSV in the U.S.
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FDA approves Moderna’s RSV vaccine mRESVIA
Pharmaceutical Technology
JUNE 3, 2024
Moderna has secured approval from the US Food and Drug Administration (FDA) for mRESVIA (respiratory syncytial virus vaccine).
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FDA approves AstraZeneca FluMist ‘flu vaccine for self-administration
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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Pfizer, BioNTech are first to seek full FDA approval of a coronavirus vaccine
Bio Pharma Dive
MAY 7, 2021
The milestone filing could pave the way for the shot's use beyond the pandemic and give employers the legal heft to require vaccination, a key step toward herd immunity in the U.S.
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FDA approves IND application for Everest’s cancer vaccine
Pharmaceutical Technology
MARCH 24, 2025
The FDA has granted approval for the IND application of Everest Medicines tumour-associated antigen (TAA) vaccine, EVM14.
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FDA approves Pfizer-BioNTech’s Omicron XBB.1.5-adapted Covid-19 vaccine
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 approves first RSV vaccine, clearing GSK’s Arexvy for older adults
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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5 FDA approval decisions to watch in the second quarter
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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5 FDA approval decisions to watch in the 4th quarter
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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US FDA approves Merck’s Ebola vaccine for under-18s
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 approves updated COVID boosters from Pfizer, Moderna
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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5 FDA approval decisions to watch in the fourth quarter
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 approves Pfizer’s RSV vaccine for use in pregnancy
Bio Pharma Dive
AUGUST 21, 2023
The expanded approval follows the FDA’s May clearance of the shot, called Abrysvo, in older adults.
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GSK’s RSV vaccine receives FDA approval for adults aged 50 to 59
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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US FDA approves GSK’s pertussis vaccine to protect newborn
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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Pfizer seeks full FDA approval of Paxlovid as questions about its benefits grow
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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GSK’s Penmenvy meningococcal vaccine gains FDA approval
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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Emergent gains FDA approval for ACAM2000 vaccine for Mpox
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 approves updated mRNA vaccines for Covid-19
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 approves Pfizer/BioNTech and Moderna’s adapted COVID-19 vaccines
Pharma Times
SEPTEMBER 18, 2023
The updated vaccines more closely target current circulating variants - News - PharmaTimes
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FDA approves Bavarian Nordic’s freeze-dried mpox and smallpox vaccine
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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Pfizer, BioNTech ask FDA approval to ease temperature requirements for coronavirus shot
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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Top biopharmaceutical Covid-19 vaccine companies boosted with over 80% revenue growth
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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Valneva wins FDA approval for the first chikungunya vaccine
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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Merck takes aim at Pfizer with pneumonia vaccine data
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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VBI Vaccines Gets FDA Approval for First Three-Antigen Hepatitis B Shot
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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Merck’s Capvaxive Wins FDA Approval as First Pneumonia Vaccine Designed for Adults
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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Cyfendus Anthrax Vaccine Wins FDA Approval
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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Merck’s Next-Generation Pneumonia Vaccine Gets FDA Approval
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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Moderna gets FDA okay for RSV vaccine mResvia
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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Merck Wins Key FDA Approval for Pediatric Pneumococcal Vaccine
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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Bavarian Nordic scoops FDA approval for chikungunya vaccine in adults and teens
Pharmaceutical Technology
FEBRUARY 17, 2025
Bavarian Nordic sets up a bout with Valnevas Ixchiq, the formers Vimkunya already having an edge in population reach.
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Moderna reports positive RSV vaccine results, pressuring Pfizer, GSK
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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Novo builds heart failure case for semaglutide; Ventyx CFO departs
Bio Pharma Dive
AUGUST 30, 2024
Elsewhere, the FDA approved a vaccine for mpox and a biotech planned layoffs. A new analysis showed semaglutide reduced the risk of worsening heart failure.
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Merck gets shot in the arm with FDA approval for first pneumococcal vaccine designed for adults
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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Blue Water Biotech shores up portfolio with purchase of six FDA-approved treatments
Pharmaceutical Technology
JUNE 14, 2023
All six treatments are US Food and Drug Administration (FDA) approved. Blue Water bought the FDA-approved benign prostatic hyperplasia treatment from Veru for a total cost of $100m in April 2023. “We At market open, shares in Blue Water surged 90% higher than the previous day’s (13 June) market close.
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Pfizer/BioNTech and Moderna Seek Full FDA Approval for COVID-19 Vaccines
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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Valneva pushes FDA approval date for chikungunya vaccine
Pharmaceutical Technology
AUGUST 14, 2023
The PDUFA date has been pushed by three months to November to allow for more time for Phase IV activities.
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MSD competes with Pfizer in pneumococcal vaccine market after FDA approval
Pharmaceutical Technology
JUNE 18, 2024
The CDC Advisory Committee on Immunization Practices is expected to meet on 27 June to discuss the use of Capvaxive in adults.
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Pfizer’s maternal RSV vaccine receives FDA approval
Pharma Times
AUGUST 23, 2023
The decision allows Abrysvo to be given to those who are 32 to 36 weeks into their pregnancy - News - PharmaTimes
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Pfizer, BioNTech file for FDA approval of COVID booster shot
pharmaphorum
AUGUST 16, 2021
Pfizer and BioNTech have formally asked for FDA approval of a third dose of their COVID-19 vaccine BNT162b2 in people aged over 16, as the US prepares to get its booster campaign underway. The post Pfizer, BioNTech file for FDA approval of COVID booster shot appeared first on.
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