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.

FDA Approval 355

FDA Approval Vaccination Vaccine 355

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?

FDA Approval 98

FDA Approval Vaccination Vaccine Antibody 98

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.

FDA Approval 246

FDA Approval Vaccination Vaccine Regulation 246

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.

FDA Approval 323

FDA Approval Vaccination Vaccine 323

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.

FDA Approval 80

FDA Approval Vaccination Vaccine Trials 80

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

Drug Discovery World

NOVEMBER 13, 2023

The US Food and Drug Administration (FDA) has approved Ixchiq, Valneva’s single-dose, live-attenuated vaccine for the prevention of disease caused by chikungunya virus (CHIKV). The vaccine is indicated in individuals 18 years of age and older who are at increased risk of exposure to CHIKV.

FDA Approval 59

FDA Approval Vaccination Vaccine Antibody 59

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.

FDA Approval 92

FDA Approval Vaccination Vaccine 92

XTalks

NOVEMBER 15, 2023

France-based biotech Valneva has won approval from the US Food and Drug Administration (FDA) for its chikungunya vaccine Ixchiq for the prevention of infection from the chikungunya virus. The vaccine is approved for adults 18 years of age and older who are at increased risk of exposure to the virus.

FDA Approval 59

FDA Approval Vaccination Vaccine In-Vitro 59

Pharma Times

SEPTEMBER 18, 2023

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

FDA Approval 148

FDA Approval Vaccination Vaccine 148

Drug Discovery World

JUNE 6, 2023

The US Food and Drug Administration (FDA) has approved Pfizer’s bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine Abrysvo in individuals 60 years and older. A vaccine to help prevent RSV had been an elusive public health goal for more than half a century.

FDA Approval 52

FDA Approval Vaccination Vaccine Clinical Trials 52

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

FDA Approval 89

FDA Approval Vaccination Vaccine Immune Response 89

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.

FDA Approval 130

FDA Approval Cardiology Marketing Vaccination 130

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.

FDA Approval 103

FDA Approval Vaccination Vaccine Marketing 103

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.

FDA Approval 361

FDA Approval Vaccination Vaccine Drugs 361

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.

FDA Approval 323

FDA Approval Regulation Vaccination Vaccine 323

Drug Discovery World

AUGUST 23, 2023

The US Food and Drug Administration (FDA) has approved the first vaccine for pregnant individuals to prevent respiratory syncytial virus (RSV) in infants. The FDA approved Abrysvo in May for the prevention of LRTD caused by RSV in individuals 60 years of age and older.

FDA Approval 52

FDA Approval Vaccination Vaccine Clinical Trials 52

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. It is an accelerated approval and subject to a confirmatory, real-world study. Valneva has won the race in the U.S. |

FDA Approval 91

FDA Approval Vaccination Vaccine 91

JAMA Internal Medicine

APRIL 10, 2022

This survey study assesses vaccination intentions of unvaccinated US adults in response to full US Food and Drug Administration (FDA) approval of the BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine and any demographic characteristics associated with those intentions.

FDA Approval 63

FDA Approval Vaccination Vaccine Drugs 63

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.

FDA Approval 352

FDA Approval Antibody Vaccination Vaccine 352

Fierce Pharma

NOVEMBER 28, 2023

Armed with a full FDA approval after four years supplying its anthrax vaccine under a pre-emergency use authorization, Emergent BioSolutions is expanding its countermeasure supply pact with the Uni | Armed with a full FDA approval after four years supplying its anthrax vaccine under a pre-emergency use authorization, Emergent BioSolutions is expanding (..)

Vaccination 101

Vaccination Vaccine FDA Approval 101

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.

FDA Approval 98

FDA Approval Vaccination Vaccine Licensing 98

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.

FDA Approval 130

FDA Approval Vaccination Vaccine 130

XTalks

DECEMBER 12, 2023

After receiving US Food and Drug Administration (FDA) approval for Fabhalta (iptacopan) last week for the treatment of the rare blood disorder paroxysmal nocturnal hemoglobinuria (PNH), Novartis presented trial data yesterday showing the drug’s promise in another indication.

FDA Approval 95

FDA Approval Bacteria Trials Protein 95

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.

FDA Approval 264

FDA Approval Vaccination Vaccine Drugs 264

BioSpace

MARCH 4, 2023

GSK Wins First-Ever FDA Approval for an RSV Vaccine 5/3/2023

FDA Approval 54

FDA Approval Vaccination Vaccine 54

Pharmaceutical Technology

APRIL 11, 2023

In August 2021, Zydus secured emergency use authorisation (EUA) from the Drugs Controller General of India for its Covid-19 deoxyribonucleic acid (DNA) plasmid vaccine, ZyCoV-D. The vaccine, which generates the SARS-CoV-2 viral spike protein on administration, induces the immune system’s cellular and humoral arm-mediated immune response.

FDA Approval 130

FDA Approval Drugs Immune Response Manufacturing 130

BioSpace

JUNE 5, 2022

GSK's MMR vaccine is only the second to be approved in the United States for protection against measles, mumps and rubella. The first, licensed to Merck, was approved in 1971.

FDA Approval 98

FDA Approval Vaccination Vaccine Licensing 98

World of DTC Marketing

NOVEMBER 12, 2020

Pfizer did not take government money to develop a COVID vaccine and said the release of preliminary vaccine data was based on receiving the data on Monday. That, however, didn’t stop a conspiracy loving imbecile from blaming the FDA and Pfizer. Of these, 4 (19.0%) received Accelerated Approval.

Vaccination 187

Vaccination Vaccine FDA Approval Pharma Companies 187

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.

Vaccination 147

Vaccination Vaccine FDA Approval Trials 147

XTalks

DECEMBER 8, 2021

Moderna’s CEO sparked concerns when he said the current vaccines likely won’t be effective against Omicron, while Pfizer’s CEO said vaccines for COVID-19 will likely be needed for many years. The team also talked about a new hepatitis B vaccine from VBI Vaccines that received FDA approval for adults.

Life Science 98

Life Science FDA Approval Vaccination Vaccine 98

Drug Discovery World

MARCH 26, 2024

It is approved in adults and adolescents (12 years of age and older weighing at least 40kg) who are moderate-to-severely immune compromised due to certain medical conditions or receipt of certain immunosuppressive medications or treatments and are unlikely to mount an adequate immune response to Covid-19 vaccination.

FDA Approval 52

FDA Approval Antibody Clinical Trials Clinical Trials 52

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.

FDA Approval 171

FDA Approval Vaccination Vaccine Development 171

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

FDA Approval 99

FDA Approval Vaccination Vaccine 99

XTalks

APRIL 24, 2024

ImmunityBio’s Anktiva (N-803, or nogapendekin alfa inbakicept-pmln) along with the Bacillus Calmette-Guérin (BCG) vaccine has won US Food and Drug Administration (FDA) approval for the treatment of non-muscle invasive bladder cancer (NMIBC). Anktiva is mixed together with the BCG vaccine before administration.

FDA Approval 52

FDA Approval Vaccination Vaccine Sales 52

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.

FDA Approval 235

FDA Approval Vaccination Vaccine 235

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.

Vaccination 272

Vaccination Vaccine Sales Generic Drugs 272