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.

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FDA Approval Vaccination Vaccine Drugs 75

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 352

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

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.

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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 264

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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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.

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FDA Approval Bacteria Trials Protein 95

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

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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Drug Discovery World

MARCH 26, 2024

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to half-life extended monoclonal antibody (mAb) Pemgarda (pemivibart, or VYD222) for the pre-exposure prophylaxis (prevention) of Covid-19.

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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.

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XTalks

NOVEMBER 23, 2022

In this episode, Ayesha talked about the breakthrough FDA approval of Provention Bio’s Tzield for delaying the onset of type 1 diabetes in adult and pediatric patients. It’s the first approved treatment for slowing the progression of stage 2 type 1 diabetes to stage 3, the stage at which a clinical diagnosis is made.

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Life Science FDA Approval Vaccination Vaccine 52

NY Times

MAY 7, 2021

The vaccine has been used under an emergency authorization since December. A decision by the Food and Drug Administration could take months.

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FDA Approval Vaccination Vaccine Drugs 98

XTalks

JUNE 5, 2023

Pfizer has announced that its respiratory syncytial virus (RSV) vaccine, Abrysvo, has received approval from the US Food and Drug Administration (FDA). Abrysvo is an unadjuvanted vaccine and is composed of two preF proteins selected to optimize protection against RSV A and B strains.

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XTalks

DECEMBER 15, 2021

Ayesha discusses the FDA approval of Biohaven’s intranasal spray Zavegepant for the acute treatment of migraines. The drug is the first CGRP receptor antagonist in a nasal spray formulation. The team also talked about results from an early-stage trial evaluating Moderna’s new mRNA-based influenza vaccine in adults.

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Pfizer

JULY 8, 2022

FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. The vaccine was previously made available to this age group in the U.S. Pfizer and BioNTech Announce U.S.

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FDA Approval Vaccination Vaccine Clinical Trials 102

XTalks

APRIL 27, 2022

Gilead’s Veklury (remdesivir) gets FDA approval to treat young children with COVID-19 and becomes the first and only approved COVID-19 treatment for children under 12. In the US, the vaccination for the virus is currently provided to individuals five years of age and older. Veklury as a COVID-19 Drug for Infants .

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FDA Approval In-Vitro Clinical Trials Clinical Trials 98

XTalks

MAY 5, 2023

This week, the US Food and Drug Administration (FDA) approved the world’s first respiratory syncytial virus (RSV) vaccine. The shot, named Arexvy, is approved for adults aged 60 years and older and was developed by GlaxoSmithKline (GSK). Who Should Get the RSV Vaccine Arexvy?

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Drug Discovery World

JULY 20, 2023

The US Food and Drug Administration (FDA) has granted marketing authorisations to several new therapeutics over the last month that will have a significant impact on areas of unmet need and the evolution of future treatments.

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Drug Discovery World

NOVEMBER 2, 2023

The US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has voted to recommend Pfizer’s Penbraya (meningococcal group A, B, C, W and Y vaccine) for the prevention of the five most common meningococcal serogroups.

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Vaccination Vaccine FDA Approval Drugs 52

XTalks

SEPTEMBER 22, 2023

In time for respiratory virus season this fall and winter, the US Food and Drug Administration (FDA) approved updated COVID vaccines from Pfizer/BioNTech and Moderna last week, followed by an endorsement from the Centers for Disease Control and Prevention (CDC) a day later. The updated COVID vaccines target the XBB.1.5

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XTalks

OCTOBER 31, 2023

GlaxoSmithKline (GSK) Canada has roped in both older and younger versions of Wayne Gretzky for a new ad for its respiratory syncytial virus (RSV) vaccine Arexvy. The RSV vaccine ad has the now 62-year-old hockey legend looking into a mirror and seeing his younger self, specifically an AI-generated 20-year-old version of himself.

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Pharmaceutical Technology

AUGUST 23, 2022

Pfizer and BioNTech have filed an application seeking Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for a booster dosage of an Omicron BA.4/BA.5-adapted 5-adapted bivalent vaccine for Covid-19 in people aged 12 years and above. 1-adapted vaccine. On obtaining the FDA EUA, the Omicron BA.4/BA.5-adapted

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pharmaphorum

SEPTEMBER 16, 2021

Takeda has had a run of bad luck with its Wave1 pipeline of new drug candidates of late, but can now celebrate a vestry after getting FDA approval for first-in-class lung cancer therapy Exkivity. The post Takeda gets a win for its Wave1 pipeline, as Exkivity nabs FDA approval appeared first on.

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XTalks

OCTOBER 14, 2022

This week, GSK announced in a press release that the US Food and Drug Administration (FDA) had approved Boostrix as an immunization for pregnant women for the prevention of whooping cough in newborn infants. Boostrix is the first vaccine in the US indicated for the protection of newborns under two months of age from pertussis.

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FDA Approval Vaccination Vaccine Protein 98

Fierce Pharma

JULY 18, 2023

After bagging a highly anticipated FDA nod Monday, Sanofi and AstraZeneca’s respiratory syncytial virus (RSV) antibody now has a date on a committee's calendar to determine its place in U.S. 3 to evaluate the new drug. The panel has set a date for Aug.

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Antibody Vaccination Vaccine FDA Approval 77

The Pharma Data

AUGUST 15, 2021

Food and Drug Administration (FDA) has approved TICOVAC (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older. 1 TICOVAC is the only FDA-approved vaccine to help protect U.S. 1 TICOVAC is the only FDA-approved vaccine to help protect U.S.

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Pharmaceutical Technology

DECEMBER 20, 2022

This downturn in market cap was attributed to a decline in the demand for Covid-19 vaccines and therapies. The growing competition from generic drugs presents challenges for the top 20 players placing pressure on drug prices. billion for Q3, according to GlobalData’s Drugs Database. trillion in Q2 2022 to $3.14

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XTalks

SEPTEMBER 22, 2021

In this episode, Ayesha discusses the FDA’s pending decision on authorizing COVID-19 vaccine boosters for the general public. While an FDA vaccine advisory committee voted against boosters for individuals 16 years of age and older last week, the FDA is still working towards its final decision on the matter.

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XTalks

MAY 2, 2024

In 2023, the US Food and Drug Administration (FDA) approved a record-breaking 61 drugs, the most in history. Since January, the FDA has already signed off on more than a dozen novel drugs. The agency is reviewing applications for several highly anticipated drugs for approval in 2024.

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Delveinsight

AUGUST 17, 2021

FDA’s Green Flag to Keytruda and Lenvima combination by Merck and Eisai for Advanced renal cell carcinoma (RCC). The FDA approved the combination of Keytruda and Lenvima produced by Merck and Eisai, as a first-line treatment of adult patients with advanced renal cell carcinoma (RCC). Acting FDA Commissioner Janet Woodcock, M.D.

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FDA Law Blog

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. Brand drugs, generic drugs, and medical devices alike have all been the target of state failure-to-warn litigation; in a recent case, OTC acetaminophen is the target.

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FDA Approval Production Drugs Generic Drugs 40

Scienmag

JUNE 28, 2021

Vaccines likely induce strong, persistent immunity to COVID-19 Credit: Matt Miller The first two COVID-19 vaccines authorized for emergency use by the Food and Drug Administration (FDA) employed a technology that had never before been used in FDA-approved vaccines.

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XTalks

NOVEMBER 9, 2023

Abbott’s molecular human papillomavirus (HPV) screening solution has received approval from the US Food and Drug Administration (FDA) for detecting high-risk HPV infections and as a primary cervical cancer screening tool. The HPV test is an addition to Abbott’s Alinity m diagnostic assay family.

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FDA Approval HR Genotype Life Science 64

STAT News

MARCH 30, 2023

Food and Drug Administration approved selling Narcan — the brand name for naloxone — without a prescription, setting the overdose-reversing drug on course to become the first opioid treatment drug to be sold over the counter, the Associated Press writes. Best of luck, everyone. … The U.S.

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Drug Discovery World

APRIL 6, 2023

Gohibic (vilobelimab) has been granted an Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for the treatment of Covid-19 in hospitalised adults. The post FDA approves Gohibic for emergency use in Covid-19 patients appeared first on Drug Discovery World (DDW).

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The Pharma Data

FEBRUARY 25, 2022

Several FDA-approved drugs – including for type 2 diabetes, hepatitis C and HIV – significantly reduce the ability of the Delta variant of SARS-CoV-2 to replicate in human cells, according to new research led by scientists at Penn State. Pfizer’s COVID-19 therapy Paxlovid, for example, targets Mpro.

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