The Pharma Data

FEBRUARY 25, 2022

The study met its primary goal by demonstrating pharmacokinetic equivalence in patients who switched multiple times between treatment with the two medicines. The FDA approval was based on the review of a comprehensive data package which demonstrated biosimilarity of ABRILADA to the reference product.

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Biosimilars FDA FDA Approval Small Molecule 52

Agency IQ

DECEMBER 1, 2023

FDA’s guidance on developing products to prevent or treat Covid-19 Of the five guidance documents that received an extension, one addresses the development of drugs and biological products for Covid-19. It also stated that companies should consider whether an investigational product might interact with an administered vaccine for Covid-19.

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Drug Discovery World

JULY 8, 2024

RNA vaccines: encoding linear information The first category of RNA therapeutics is probably the most well recognised in medicine – mRNA vaccines. By silencing transthyretin (TTR) mRNA, patisiran decreases the production of TTR protein, the molecule responsible for causing the disease.

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The Pharma Data

SEPTEMBER 1, 2020

“Alongside our industry-leading collaborators, we are investigating novel endpoints, brain volume and cognition, which may help to further our understanding of the safety and efficacy profile of Zeposia and can advance transformational science for multiple sclerosis patients experiencing this unpredictable, debilitating disease.”.

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Clinical Trials Treatment Trials Disease 52

The Pharma Data

APRIL 27, 2021

In April 2020, mobocertinib received Breakthrough Therapy Designation from the FDA for patients with EGFR Exon20 insertion+ metastatic non-small cell lung cancer (mNSCLC) whose disease has progressed on or after platinum-based chemotherapy. We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines.

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FDA Treatment Pharmaceutical Companies FDA Approval 52

The Pharma Data

MARCH 16, 2021

1,2 TREMFYA is the first and only IL-23 inhibitor therapy approved in the U.S. PsA can be a chronically painful and debilitating disease, and many PsA patients are still searching for enduring relief of their symptoms,” said Philip J. Vice President, Rheumatology Disease Area Leader, Janssen Research & Development, LLC.

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Treatment Pharmacokinetics Disease Pharmaceutical Companies 52

The Pharma Data

APRIL 26, 2022

Before now, Veklury was only approved to treat certain adults and pediatric patients (12 years of age and older who weigh at least 40 kilograms, which is about 88 pounds) with COVID-19. “As director of the FDA’s Center for Drug Evaluation and Research. The FDA urges the public to get vaccinated and receive a booster when eligible.

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FDA Approval FDA Treatment Vaccine 52