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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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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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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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 9, 2023

Also known as palivizumab, Sobi ‘s Synagis was the first FDA-approved monoclonal antibody used in children at high risk of RSV disease. After a long period without any new approvals, in May, the FDA approved GSK’s vaccine Arexvy for the prevention of LRTD caused by RSV in individuals 60 and older.

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FDA Approval Antibody Allergies Packaging 147

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

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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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

NOVEMBER 5, 2024

Its lead candidate, PL-14, targets nasal allergies and is scheduled for US Food and Drug Administration (FDA) submission via the 510(k) pathway, with preclinical trials expected to start in the second quarter of 2025 and pivotal trials by the end of 2025.

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Drug Delivery Drugs Immune Response Allergies 111

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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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.

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Gene Therapy Gene FDA Approval Trials 52

The Pharma Data

DECEMBER 17, 2020

There will be a brand-new treatment for actinic keratosis on the market next year, with Tuesday’s FDA approval of Athenix’s Klisyri® (tirbanibulin). The FDA approval of Klisyri is a significant milestone for Athenex. The new two-hour infusion time was previously approved by the European Medicines Agency (EMA) in May 2020.

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FDA Approval Genome Genomics Production 52

XTalks

NOVEMBER 30, 2023

New FDA-Approved Treatments For HIV HIV treatment involves the administration of combined antiretroviral therapy (ART) to effectively suppress the viral load, maintain or enhance immune function and reduce the risk of opportunistic infections and cancers commonly associated with HIV. aiming to end the HIV epidemic by 2030.

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Bioengineer

JULY 20, 2021

FDA approval based on positive results of international, multi-center ProDERM study. “The FDA approval of Octagam® 10% as a safe and effective treatment for dermatomyositis in adults is exciting news for patients who previously relied on unapproved treatments,” said Octapharma USA President Flemming Nielsen.

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FDA Approval Clinical Trials Clinical Trials Trials 40

The Pharma Data

DECEMBER 13, 2020

Food and Drug Administration (FDA) approved a first-of-its-kind intentional genomic alteration (IGA) in a line of domestic pigs, referred to as GalSafe pigs, which may be used for food or human therapeutics. SILVER SPRING, Md. , 14, 2020 /PRNewswire/ — Today, the U.S. In the U.S.,

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FDA Approval Genome Genomics Production 52

The Pharma Data

JULY 29, 2021

Tonya Winders, CEO & President, Allergy and Asthma Network (AAN) and President of Global Allergy and Airways Patient Platform (GAAPP) commented: “Patients with chronic rhinosinusitis with nasal polyps experience unpleasant symptoms across a range of severities.

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FDA Approval Clinical Trials Clinical Trials Trials 52

The Pharma Data

AUGUST 17, 2021

Do not take Lyumjev or Humalog if you have: symptoms of low blood sugar (hypoglycemia) an allergy to insulin lispro-aabc, Humalog, or any of the ingredients in Lyumjev or Humalog. If your doctor decides to give your child any insulin products, he or she may give you special instructions.

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Insulin FDA Approval Doctor Doctors 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

XTalks

APRIL 21, 2023

Singulair (Montelukast) For Asthma: How It Works and Side Effects Merck’s Singulair (montelukast) was first FDA-approved in 1998 for the prophylaxis and chronic treatment of asthma. At the beginning of 2003, it was approved by the FDA for the treatment of seasonal allergic rhinitis.

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Life Science Allergies Drugs FDA Approval 98

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

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

The Pharma Data

NOVEMBER 20, 2020

The janus kinase inhibitor baricitinib is currently FDA-approved for treating moderately to severely active rheumatoid arthritis. ” The FDA granted the EUA based on data from the ACTT-2 trial, a randomized, double-blind, placebo-controlled clinical trial conducted by the National Institute of Allergy and Infectious Diseases.

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Allergies FDA Approval Clinical Trials Clinical Trials 52

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

DECEMBER 30, 2020

Nestlé and Peanut Allergies – In August, Nestlé Health Science acquired the outstanding stakes of Aimmune for $2.6 billion in cash to gain control of FDA-approved Palforzia , a first-of-its-kind treatment for patients with peanut allergies. Nestlé Health Science has a history of advancing nutritional therapies.

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Antibody Allergies Branding Dermatology 52

The Pharma Data

DECEMBER 31, 2020

These reactions can be treated, and most patients with allergies can still get the vaccine. In mid-December, the FDA approved Orgovyx (relugolix), the first oral gonadotropin-releasing hormone (GnRH) receptor antagonist for men with advanced prostate cancer. of men, compared with 88.8%

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Vaccine Vaccination FDA Approval Hormones 52

The Pharma Data

OCTOBER 26, 2020

FDA Actions. FDA Approval: Last week the FDA approved Veklury (remdesivir) for the treatment of COVID-19 requiring hospitalization in adults and pediatric patients (12 years of age and older). News information is not all-inclusive and updates are published once a week on Tuesdays. . .

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Antibody Vaccine Vaccination Manufacturing 52

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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