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. TPOXX was approved by the U.S. Food and Drug Administration in 2018 to treat smallpox and was authorized for use in treating monkeypox.

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XTalks

SEPTEMBER 28, 2023

In most cases, commercials are regulated to ensure they provide accurate information, include the benefits and risks of the drugs and encourage viewers to talk to their healthcare providers about the medication. The report included a roundup of the top ten TV ad debuts this year, with pharma drugs clinching the top three spots.

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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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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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Pharmaceutical Technology

JUNE 9, 2023

A US Food and Drug Administration (FDA) Advisory Committee (AdCom) has voted unanimously in favour of AstraZeneca’s and Sanofi’s respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) prophylactic nirsevimab for use in newborns and infants entering their first RSV season.

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pharmaphorum

JANUARY 12, 2023

Airsupra (PT027), a new asthma rescue treatment developed by AstraZeneca (AZ) and development partner Avillion, has been approved by the US Food and Drug Administration (FDA). Additionally, under its 2018 agreement, Avillion had regulatory responsibility, including filing the New Drug Application (NDA) through to FDA approval.

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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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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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XTalks

JANUARY 17, 2023

The US Food and Drug Administration (FDA) granted approval to AstraZeneca’s Airsupra (albuterol/budesonide), formerly known as PT027, for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of asthma attacks in individuals aged 18 years and older who have asthma.

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XTalks

DECEMBER 20, 2022

Idacio (adalimumab-aacf) is a citrate-free formulation of adalimumab developed by Fresenius Kabi and is now the eighth biosimilar of Humira (adalimumab) to be approved by the US Food and Drug Administration (FDA). There are now 40 FDA approved biosimilars in the US. Why is Idacio a Cost-Effective Drug?

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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

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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The Pharma Data

AUGUST 11, 2020

Photo by FDA/CDC. Gilead Sciences has asked the FDA to approve its drug remdesivir to treat COVID-19 patients. The drug would go under the brand name of Veklury. It has not received general approval to treat the virus in the US, but has in several European countries and Japan.

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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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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

DECEMBER 17, 2020

Food and Drug Administration (FDA) had several approvals this week. Food and Drug Administration (FDA) has approved belimumab (Benlysta®), the first-ever treatment for adults with lupus nephritis (LN) who are currently receiving standard therapy. When Pigs Fly Allergy-friendly. GlaxoSmithKline.

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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. The FDA, an agency within the U.S. Food and Drug Administration. In the U.S.,

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XTalks

APRIL 21, 2023

Cerner Enviza, an Oracle-owned company, and John Snow Labs are now supporting the US Food and Drug Administration’s (FDA) drug safety Sentinel Initiative. At the beginning of 2003, it was approved by the FDA for the treatment of seasonal allergic rhinitis.

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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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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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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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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). “The anti-HIV drug (saquinavir) showed good affinity, but not good stability.”

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The Pharma Data

JULY 29, 2021

First IL-5 therapy approved as an add-on treatment in the US for adults with chronic rhinosinusitis with nasal polyps to target eosinophilic inflammation Fourth indication for mepolizumab in the US for eosinophil-driven diseases.

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The Pharma Data

JULY 29, 2021

Food and Drug Administration (FDA) has approved a label expansion of BOTOX ® to include eight new muscles for the treatment of upper limb spasticity in adults. BOTOX ® was first approved by the FDA in 1989 for two rare eye muscle disorders – blepharospasm and strabismus in adults. million adults in the U.S.

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The Pharma Data

AUGUST 17, 2021

approval of pump use for Lilly’s novel insulin is latest development designed to help people with diabetes manage blood sugar levels. 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.

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The Pharma Data

NOVEMBER 20, 2020

Food and Drug Administration announced Thursday. The janus kinase inhibitor baricitinib is currently FDA-approved for treating moderately to severely active rheumatoid arthritis. FRIDAY, Nov.

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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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XTalks

AUGUST 2, 2023

Pfizer’s Top 5 Best-Selling Drugs of 2022: 1) Comirnaty Comirnaty is an mRNA-based vaccine indicated for the prevention of COVID-19. Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. Pfizer’s total global revenue in 2022 from Comirnaty was $37.81

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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. today announced that the U.S. indications.

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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). Food and Drug Administration greenlit the restart of AstraZeneca’s Phase III COVID-19 vaccine trial, the U.K.

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XTalks

DECEMBER 20, 2023

These advancements and trends addressed important industry challenges and offered opportunities to foster innovations and solutions in areas including drug development, healthcare and medical devices. The shortages have been partly blamed on the off-label prescribing of the drugs for weight loss.

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The Pharma Data

DECEMBER 30, 2020

That company’s breast cancer treatment Trodelvy, which was granted accelerated approval from the U.S. Andexxa, was approved by the U.S. Food and Drug Administration in 2018 and is currently the only approved Factor Xa inhibitor reversal agent. Nestlé Health Science has a history of advancing nutritional therapies.

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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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Pfizer

JANUARY 27, 2023

COMIRNATY® (COVID-19 Vaccine, mRNA) INDICATION COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older. AUTHORIZED USE The U.S.

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The Pharma Data

MARCH 30, 2021

Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for atogepant, an investigational orally administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant), for the preventive treatment of migraine in adults who meet criteria for episodic migraine. UBRELVY® Indication.

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The Pharma Data

DECEMBER 31, 2020

Food and Drug Administration (FDA) issued Emergency Use Authorization for two COVID-19 vaccines: Pfizer-BioNTech’s BNT162b2 and Moderna’s mRNA-1273. These reactions can be treated, and most patients with allergies can still get the vaccine. FDA Approves First-In-Class Topical Klisyri to Treat Actinic Keratosis .

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The Pharma Data

NOVEMBER 25, 2020

November 25, 2020 — Under FDA law, approval of a new drug requires substantial evidence of effectiveness and a demonstration of safety for the drug’s intended use(s). The approval of remdesivir ( Veklury ) for the treatment of patients hospitalized with COVID-19 met this legal and scientific standard.

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