The Pharma Data

AUGUST 4, 2020

. Janssen has received US Food and Drug Administration (FDA) approval for its Spravato (esketamine) CIII nasal spray, in combination with an oral antidepressant, to treat depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behaviour. Source link. .

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The Pharma Data

JANUARY 21, 2021

Today’s FDA approval of Cabenuva represents a shift in the way HIV is treated, offering people living with HIV a completely new approach to care,” said Lynn Baxter, Head of North America, ViiV Healthcare. The approval was built on the Phase III ATLAS and FLAIR trials. Janssen is a Johnson & Johnson company.

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The Pharma Data

JANUARY 17, 2021

Food and Drug Administration (FDA) approved Janssen Pharmaceuticals ’ (a Johnson and Johnson company) Darzalex Faspro for adults with newly diagnosed light chain amyloidosis. It was approved in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd). Michael Vi/Shutterstock. It was developed with Genmab.

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The Pharma Data

APRIL 26, 2022

director of the FDA’s Center for Drug Evaluation and Research. Today’s approval of the first COVID-19 therapeutic for this population demonstrates the agency’s commitment to that need.”. Learn more about FDA-approved and authorized COVID-19 vaccines. The only approved dosage form is Veklury for injection.

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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. The Phase 1 trial is expected to be conducted at sites in Baltimore, Maryland and Washington, DC.

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The Pharma Data

DECEMBER 21, 2020

FDA Approves First Oral Hormone Therapy for Advanced Prostate Cancer. 21, 2020 — Orgovyx (relugolix) is now approved to treat advanced prostate cancer and is the first oral hormone therapy approved for this indication, the U.S. Professional. MONDAY, Dec. Food and Drug Administration announced Friday.

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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

NOVEMBER 27, 2020

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. This indication is approved under accelerated approval regulation based on overall response rate and duration of response. The FDA granted approval under the accelerated approval regulation. NEW YORK, Nov.

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The Pharma Data

JULY 8, 2021

Food and Drug Administration (FDA) has approved an expanded label for KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of patients with locally advanced cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation. Merck has the industry’s largest immuno-oncology clinical research program.

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The Pharma Data

JULY 8, 2021

The update includes an addition to the Indications and Usage section of the label (Section 1) to emphasize the disease stages studied in the clinical trials, as seen below ( italics to note updated language). Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

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The Pharma Data

AUGUST 31, 2021

10), as determined by an FDA-approved test, or in patients who were not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication was approved under accelerated approval based on tumor response rate and duration of response.

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The Pharma Data

JANUARY 17, 2021

LAPS Triple Agonist (HM15211), a triple agonist, has demonstrated a fatty liver reduction effect of 50% or greater through the recent clinical trials in U.S. Poziotinib , which succeeded in clinical trials for HER2 mutated non-small cell carcinoma (NSCLC) patients last year, is planned to be submitted to the U.S.

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The Pharma Data

MAY 27, 2022

Novartis today announced the US Food and Drug Administration (FDA) has granted accelerated approval for Kymriah ® (tisagenlecleucel) for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy.

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Advarra

JUNE 20, 2023

According to a 10-year oncology research study conducted by the Biotechnology Innovation Organization (BIO), only 5.1% of new cancer drugs tested in Phase I were likely to receive Food and Drug Administration (FDA) approval. Oncology research is unique in many ways, including the challenges researchers face.

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The Pharma Data

NOVEMBER 2, 2020

FDA Approves Bronchitol (mannitol) Inhalation Powder to Improve Pulmonary Function in Adult Patients with Cystic Fibrosis. an international research-focused healthcare Group (Chiesi Group), received U.S. Food and Drug Administration (FDA) approval of Bronchitol (mannitol) inhalation powder. in March, 2021.

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The Pharma Data

NOVEMBER 27, 2020

FDA Approves Imcivree (setmelanotide) for Chronic Weight Management in Patients with Obesity Due to POMC, PCSK1 or LEPR Deficiency. With this approval, Imcivree becomes the first-ever FDA approved therapy for these rare genetic diseases of obesity. BOSTON, Nov. in the first quarter of 2021.

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DrugBank

FEBRUARY 1, 2024

was recently profiled in the January 5, 2024 issue of Nucleic Acids Research. The article highlights the myriad ways in which we have focused on making DrugBank not just a knowledgebase, but a vital partner in your healthcare research. Vastly Expanded Clinical Trial Information Our clinical trial data has grown by 89.5%.

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The Pharma Data

OCTOBER 30, 2020

Dive into this week’s update for more details on the actions taken by the FDA in the ongoing response to the Covid-19 pandemic. FDA approves first treatment for Covid-19. On October 22, the FDA approved the antiviral drug Veklury for use in adult and pediatric patients for the treatment of Covid-19 requiring hospitalization.

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New Drug Approvals

APRIL 2, 2025

1] [2] It was developed by Vertex Pharmaceuticals , [5] and was approved for medical use in the United States in January 2025. [2] 2] [6] Suzetrigine is the first medication to be approved by the US Food and Drug Administration (FDA) in this new class of pain management medicines. [2] Suzetrigine is taken by mouth. [1]

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The Pharma Data

NOVEMBER 24, 2020

FDA Approves Oxlumo (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1. Food and Drug Administration (FDA) approved Oxlumo (lumasiran) injection for subcutaneous use, the first-ever therapy available for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients.

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Vial

JUNE 12, 2024

Utilizing PROs enables the active participation of patients in their care outcomes – both in a clinical setting and in clinical research. PROs in clinical trials are important as they capture the patient’s perspective and ensure that the impact of an intervention is comprehensively evaluated. What are PROs in clinical trials?

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Conversations in Drug Development Trends

FEBRUARY 26, 2024

With the necessary prioritization of various factors when designing your clinical trial, the patient experience can be overlooked or improperly addressed in study design. It plays a significant role in patient recruitment and retention, both of which are vital to maintaining timelines, decreasing program costs, and gaining market approval.

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The Pharma Data

FEBRUARY 25, 2022

Jardiance is the first and only heart failure therapy to demonstrate a statistically significant risk reduction in cardiovascular death or hospitalization for heart failure, regardless of ejection fraction FDA approval marks a significant breakthrough for the approximately 3 million adults in the U.S. and Europe.

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DrugBank

MAY 6, 2024

A Wave of Innovations The year 2024 has already proven to be significant for the field of biologics, witnessing a notable increase in FDA approvals. In the first quarter alone, the FDA approved 9 new biologics, a substantial rise from the 5 approvals during the same period in 2023.

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Broad Institute

JULY 17, 2024

Still, more than 90 percent of drug candidates fail in clinical trials, with even more that never make it to the clinical stage. Researchers at the Broad Institute of MIT and Harvard have developed AI models that can screen the potential biological effects of drugs before they ever enter a living organism. A fourth is in the works.

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The Pharma Data

JANUARY 22, 2021

Approval was based on data from the Phase 3 ATLAS and FLAIR studies, two randomized, open-label, controlled clinical trials in 1,182 HIV-infected adults. Researchers found no clinically relevant change from baseline in CD4+ cell counts.

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The Pharma Data

DECEMBER 17, 2020

The Alliance for Lupus Research ( LRA) President and Chief Executive Officer Kenneth M. We are particularly proud to see this approval for another indication of belimumab, having funded much of the original research that led to the drug’s development. The FDA approval of Klisyri is a significant milestone for Athenex.

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The Pharma Data

AUGUST 7, 2021

Nexviazyme has been shown in clinical trials to provide patients with improvements in respiratory function and walking distance. For decades, we’ve made it our responsibility to research how to target the M6P receptor, the key pathway for cellular uptake of enzyme replacement therapy. Patients treated with Nexviazyme had a 2.4-point

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The Pharma Data

JANUARY 15, 2021

Food and Drug Administration (FDA) approval of Darzalex Faspro ® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1] Janssen Biotech, Inc.

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The Pharma Data

NOVEMBER 16, 2020

November 16, 2020 — An independent data and safety monitoring board (DSMB) overseeing the Phase 3 trial of the investigational COVID-19 vaccine known as mRNA-1273 reviewed trial data and shared its interim analysis with the trial oversight group on Nov. 37% of trial volunteers are from racial and ethnic minorities.

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Drug Target Review

JANUARY 8, 2024

We are at the forefront of drug development in an area of research called cellular rejuvenation, which is an approach that has the potential to address many diseases of ageing by restoring aged and injured cells to a more youthful and resilient state. One way we are doing this at Life Biosciences is through partial epigenetic reprogramming.

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Codon

JULY 14, 2024

The creation of synthetic blood is one of the holy grails of biomedical research as it would alleviate such shortages and overcome current barriers to obtaining and storing blood products. However, the subsequent death of another patient thrust Denys into a contentious trial. to the European and Pacific fronts unfeasible.

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The Pharma Data

AUGUST 10, 2020

The FDA has approved Olinvyk for the management of moderate to severe pain in adult patients when their pain is severe enough to require an intravenous opioid or if alternative treatments do not work. The drug, from Trevena Inc, was also proven to reduce pain compared to a placebo. Douglas Throckmorton M.D.,

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Alta Sciences

FEBRUARY 8, 2024

President of Cognitive Research Corporation , examine simple and cognitive domains in clinical and pharmacology studies, including analysis of driving impairment. Tags Clinical Trials Weight 12 In this on-demand webinar, Ingrid Holmes , Vice President of Global Clinical Operations at Altasciences, and Dr. Gary G.

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Advarra

NOVEMBER 17, 2022

In 2016, the Food and Drug Administration (FDA) approved Spinraza (nusinersen). While the FDA’s approval of nusinersen may not seem extraordinary, it was. Nusinersen’s approval marked the first time nonclinical data supported conducting initial clinical trials involving children. Why This Guidance Now?

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The Pharma Data

JUNE 22, 2023

FDA approval Pfizer (NYSE: PFE) announced that the U.S. FASCO, Professor and Presidential Endowed Chair of Cancer Research at Huntsman Cancer Institute, University of Utah, and global lead investigator for TALAPRO-2. The primary endpoint of the trial was rPFS, and overall survival (OS) was a key secondary endpoint.

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The Pharma Data

JANUARY 22, 2021

This approval will allow some patients the option of receiving once-monthly injections in lieu of a daily oral treatment regimen,” said Dr. John Farley, director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research.

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