XTalks

JUNE 21, 2021

who is on a mission to help parents save their children from food allergies by providing them with a powder added to their milk bottles. Zakowski started this company because his nephew developed several severe food allergies. Related: Red Meat Allergy Test Gets FDA Clearance.

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Allergies Production FDA Approval Protein 98

NPR Health - Shots

APRIL 8, 2023

Patients like it, but it is not FDA-approved, so insurance usually doesn't cover it. Some doctors prescribe sublingual immunotherapy, known as SLIT, a serum taken as drops under the tongue. Image credit: Drew Angerer/Getty Images)

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Allergies FDA Approval Doctor Doctors 115

Pharmaceutical Commerce

FEBRUARY 16, 2024

Xolair (omalizumab) was previously granted FDA Priority Review status and Breakthrough Therapy Designation to prevent severe allergic reactions after accidental exposure to one or more foods in people with allergies.

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Allergies FDA Approval 52

BioTech 365

JUNE 17, 2021

FDA Approves Astepro® Allergy Nasal Spray for Over-the-Counter Use in the United States FDA Approves Astepro® Allergy Nasal Spray for Over-the-Counter Use in the United States First and only steroid-free antihistamine nasal spray for allergy relief to be available OTC … Continue reading →

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Allergies FDA Approval 40

XTalks

SEPTEMBER 27, 2024

Novartis and Genentech released a pair of new TV commercials for allergy and asthma drug Xolair (omalizumab) as part of a direct-to-consumer (DTC) nationwide campaign called “Accidents Happen.” The ad highlights that despite the care parents take in handling their children’s allergies, accidental exposure can happen.

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Allergies Marketing FDA Approval Drugs 52

STAT News

SEPTEMBER 12, 2022

 The National Institute of Allergy and Infectious Diseases is sponsoring the trial, which is being led by the AIDS Clinical Trials Group. The study is currently enrolling adults and children who have been infected with monkeypox in the U.S.

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pharmaphorum

JANUARY 12, 2023

Additionally, under its 2018 agreement, Avillion had regulatory responsibility, including filing the New Drug Application (NDA) through to FDA approval. The new approval continues the company’s unmarred success rate in clinical co-development partnerships across multiple therapeutic areas. Commenting on the approval, Bradley E.

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FDA Approval Allergies Trials Development 52

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. COMIRNATY was previously FDA approved for individuals 16 years and older in August 2021. Fri, 07/08/2022 - 11:48.

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FDA Approval Vaccine Vaccination Clinical Trials 102

Pharmaceutical Technology

JUNE 28, 2022

grant from the National Institutes of Health (NIH) unit National Institute of Allergy and Infectious Diseases (NIAID) for developing a Covid-19 oral antiviral drug. They analysed whether various Food and Drug Administration (FDA)-approved drugs acting on the hepatitis C protease could attach and hinder SARS-CoV-2 proteases.

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Development Bioinformatics Drugs Allergies 147

Pharmaceutical Commerce

DECEMBER 20, 2023

If the FDA approves the sBLA for Xolair, it would be the first drug indicated to lower allergic reactions to multiple foods after an accidental exposure.

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Allergies Licensing Licensing FDA Approval 52

XTalks

SEPTEMBER 28, 2023

Related: Top 10 Pharma TV Ad Spenders in 2022 — Anti-Inflammatories and Diabetes Drugs Dominate Bayer’s new over-the-counter (OTC) cold, flu and allergy med Astepro not only emerged as the most viewed new pharma TV ad in the first half of the year, but also topped iSpot.tv’s list of all new brand ads with 7.4

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Drugs Allergies Branding FDA Approval 105

XTalks

JANUARY 17, 2023

While albuterol rescue inhalers are currently used to alleviate symptoms of an asthma attack, they don’t treat underlying inflammation, explained Bradley Chipps, MD, former president of the American College of Allergy, Asthma and Immunology, in a statement issued by AstraZeneca.

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FDA Approval Containment Allergies Drugs 97

XTalks

DECEMBER 20, 2022

There are now 40 FDA approved biosimilars in the US. Register for this free webinar to learn about drug testing in humanized mouse models in two therapeutic areas: food allergy and inflammatory bowel diseases (IBD). XTALKS WEBINAR: Why Use Humanized Mouse Models for Translational Studies in Inflammatory Disorders?

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FDA Approval Allergies Manufacturing Clinical Trials 98

The Pharma Data

OCTOBER 22, 2020

FDA Approves Veklury (remdesivir) for the Treatment of COVID-19. Food and Drug Administration (FDA) has approved the antiviral drug Veklury (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization. The speed and rigor with which Veklury has been developed and approved in the U.S.

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The Pharma Data

AUGUST 11, 2020

It has not received general approval to treat the virus in the US, but has in several European countries and Japan. The request for approval comes nearly two months after a study from the National Institute of Allergy and Infectious Diseases which showed positive results, with the drug effectively blocking the virus from replicating.

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FDA Approval Allergies Branding Drugs 52

The Pharma Data

AUGUST 24, 2020

The treatment is being researched by scientists collaborating from American Gene Technologies, the Laboratory of Immunoregulation and the National Institute of Allergy and Infectious Diseases.

Gene Therapy 52

Gene Therapy Gene FDA Approval Trials 52

The Pharma Data

JULY 29, 2021

BOTOX ® was first approved by the FDA in 1989 for two rare eye muscle disorders – blepharospasm and strabismus in adults. In addition, the company is committed to providing resources and services, such as the BOTOX ® Savings Program , to help ensure BOTOX ® is accessible and affordable to patients. About BOTOX ®.

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Botox FDA Approval Doctors Doctor 52

Scienmag

AUGUST 13, 2020

13, 2020) — Fingolimod, an FDA-approved immunosuppressive drug used to treat multiple sclerosis flare-ups, may be used to block HIV infection and reduce the latent reservoir. […].

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FDA Approval Drugs Research Allergies 50

Trialfacts

JUNE 16, 2022

Cefazolin is a US Food and Drug Administration (FDA) approved and highly effective antibiotic that is mainly used to prevent infections during and after surgeries. musculoskeletal disease, immunologic disease, allergies, psychological/psychiatric disease, HIV, hepatitis B or C. Must not have known allergies to medication.

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Research Allergies FDA Approval Drugs 52

The Pharma Data

APRIL 14, 2021

Food and Drug Administration (FDA) has approved the company’s supplemental Biologics License Application for Xolair® (omalizumab) prefilled syringe for self-injection across all approved U.S. indications.

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FDA Approval Clinical Development Allergies Development 52

The Pharma Data

NOVEMBER 16, 2020

and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. About the COVID-19 Prevention Network: The COVID-19 Prevention Network (CoVPN) was formed by the National Institute of Allergy and Infectious Diseases (NIAID) at the U.S. Source: NIH. Posted: November 2020. Source link.

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Clinical Trials Clinical Trials Vaccine Vaccination 52

The Pharma Data

APRIL 26, 2022

A drug used to treat asthma and allergies can bind to and block a crucial protein produced by the virus SARS-CoV-2, and reduce viral replication in human immune cells, according to a new study by researchers at the Indian Institute of Science (IISc).

Protein 52

Protein Drugs Allergies FDA Approval 52

The Pharma Data

MARCH 4, 2021

Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories.

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Genetics Medicine Antibody Trials 52

The Pharma Data

NOVEMBER 25, 2020

FDA’s approval of remdesivir (Veklury) was supported by the agency’s independent, in-depth analysis of data from three randomized, controlled clinical trials that included patients hospitalized with mild-to-severe COVID-19. Source: FDA. Related Articles: Veklury (remdesivir) FDA Approval History. Source link.

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Trials Clinical Trials Clinical Trials Drugs 52

The Pharma Data

JUNE 18, 2021

BOTOX ® Cosmetic is the first and only product of its kind FDA-approved to treat three areas, temporarily improving the appearance of moderate to severe forehead lines, glabellar lines and crow’s feet in adults. Department of Health and Human Services FDA Approval Letter for BOTOX® Cosmetic for Glabellar Lines, 2002.

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Botox Cosmetics Doctors Doctor 52

The Pharma Data

JANUARY 6, 2021

NYU Grossman School of Medicine, Department of Biochemistry and Molecular Pharmacology, who was a principal investigator in the study, which was supported by grants from the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institute of Health (NIH).

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Medicine Antibody Protein In-Vitro 52

Pfizer

JULY 26, 2022

FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine FDA authorized for Emergency Use Authorization (EUA) for individuals 12 years of age and older can be used interchangeably by a vaccination provider when prepared according to their respective instructions for use. INTERCHANGEABILITY.

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Vaccine Vaccination Protein Immune Response 111

The Pharma Data

MARCH 30, 2021

Other side effects of BOTOX® include : dry mouth, discomfort or pain at injection site, tiredness, headache, neck pain, eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, dry eyes; drooping eyebrows.

Botox 52

Botox Drugs Doctors Doctor 52

Pfizer

JULY 19, 2022

FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine FDA authorized for Emergency Use Authorization (EUA) for individuals 12 years of age and older can be used interchangeably by a vaccination provider when prepared according to their respective instructions for use. INTERCHANGEABILITY.

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Vaccine Vaccination Medicine Clinical Trials 100

The Pharma Data

DECEMBER 8, 2020

and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Source: Moderna, Inc. .

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Vaccine Vaccination Manufacturing Containment 40

The Pharma Data

AUGUST 30, 2021

Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories.

Trials 52

Trials Medicine Genetics Antibody 52

Pfizer

JULY 8, 2022

FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine FDA authorized for Emergency Use Authorization (EUA) for individuals 12 years of age and older can be used interchangeably by a vaccination provider when prepared according to their respective instructions for use. INTERCHANGEABILITY.

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Vaccine Vaccination Clinical Trials Clinical Trials 81

The Pharma Data

NOVEMBER 16, 2020

and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Posted: November 2020.

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Vaccine Vaccination Clinical Trials Clinical Trials 52

The Pharma Data

SEPTEMBER 10, 2021

About BOTOX ® BOTOX ® was first approved by the FDA in 1989 for two rare eye muscle disorders – blepharospasm and strabismus in adults. Current Perspectives on the Management of Cervical Dystonia Among Global Clinicians.

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Botox Doctors Doctor Medicine 52

The Pharma Data

SEPTEMBER 8, 2021

About BOTOX ® BOTOX ® was first approved by the FDA in 1989 for two rare eye muscle disorders – blepharospasm and strabismus in adults. Atogepant is currently under review by the U.S.

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Botox Doctors Doctor Medicine 52

Pharmaceutical Technology

JANUARY 8, 2023

In December 2021, AstraZeneca’s anti- thymic stromal lymphopoietin (TSLP) antibody Tezspire (or tezepelumab) became the latest biologic to be FDA-approved as an add-on treatment for patients with severe asthma without phenotype or biomarker limitations. Still, patients require an individual-led approach.

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Antibody Trials Clinical Trials Clinical Trials 298

Scienmag

JUNE 3, 2021

FDA-approved drugs or experimental drugs with ample health data could be rapidly tested in humans for treatment of COVID-19 Credit: Scripps Research June 3, 2021 – LA JOLLA, CA–Mining the world’s most comprehensive drug repurposing collection for COVID-19 therapies, scientists have identified 90 existing drugs or drug candidates with (..)

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FDA Approval Drugs Scientist Research 57