Drug Discovery World

DECEMBER 20, 2023

The approval is based on clinical data which found that Padcev plus pembrolizumab nearly doubled median overall survival compared to standard of care platinum-based chemotherapy. In the Phase III EV-302 trial, median overall survival (OS) was 31.5 months for patients who received enfortumab vedotin-ejfv with pembrolizumab and 16.1

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Drug Discovery World

MARCH 26, 2024

Clinical trial evidence for Pemgarda The EUA of Pemgarda is based on scientific evidence, such as data showing that immunobridging was established in the CANOPY clinical trial and that the calculated serum neutralising antibody titers against JN.1

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Drug Discovery World

JUNE 6, 2023

Today’s approval is a monumental step forward in delivering on Pfizer’s commitment to help alleviate the significant burden of RSV in higher-risk populations, which includes older adults,” said Annaliesa Anderson, Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer.

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Drug Discovery World

JULY 25, 2023

The efficacy of quizartinib with chemotherapy was evaluated in the QuANTUM-First trial of 539 patients with newly diagnosed FLT3-ITD positive AML. FLT3-ITD status was determined prospectively with a clinical trial assay and verified retrospectively with the companion diagnostic LeukoStrat CDx FLT3 Mutation Assay.

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Drug Discovery World

AUGUST 21, 2023

The FDA approval is based on data from the Phase III MOVE trial, which demonstrated that palovarotene effectively reduced annualised heterotopic ossification (HO) volume compared with no treatment beyond standard of care (54% reduction with weighted linear mixed effect model).

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Drug Discovery World

DECEMBER 1, 2023

Today’s approval will offer the first approved treatment option for patients beyond surgery and radiation.” Results from the Phase III DeFi trial demonstrated that Ogsiveo provided clinically meaningful and statistically significant improvement in progression-free survival compared to placebo.

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Drug Discovery World

AUGUST 23, 2023

Pfizer’s Abrysvo (Respiratory Syncytial Virus Vaccine) was approved for use at 32-36 weeks gestational age of pregnancy to prevent lower respiratory tract disease (LRTD) and severe LRTD caused by RSV in infants from birth to six months of age. In infants and children, the risk of RSV-associated LRTD is highest during the first year of life.

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Drug Discovery World

MAY 12, 2023

Deborah Dunsire, CEO and President, Lundbeck, said: “We look forward to offering this first FDA-approved treatment option to address this significant unmet need for patients. We are grateful to the patients and caregivers who participated in these important trials.”

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Drug Discovery World

MARCH 22, 2024

I am convinced that with the data we have seen, the approval of Tryvio heralds a new era of endothelin research beyond hypertension, where we intend to investigate the utility of aprocitentan for first-in-class applications in new indications.”

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Drug Discovery World

MAY 15, 2023

The US Food and Drug Administration (FDA) has given the go-ahead to CytoAgents to initiate a US Phase Ib/IIa clinical trial investigating CTO1681 for cytokine release syndrome (CRS) in lymphoma patients receiving CAR-T cell therapy. CytoAgents anticipates the clinical trial to launch at its first trial site in the summer of 2023.

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Drug Discovery World

AUGUST 14, 2023

Janssen’s Akeega (niraparib and abiraterone acetate) is now available in the US for adult patients with deleterious or suspected deleterious BRCA-positive metastatic castration-resistant prostate cancer (mCRPC) following FDA approval. Approximately 10-15% of patients with mCRPC have BRCA gene alterations. With median follow-up at 24.8

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Drug Discovery World

DECEMBER 11, 2023

The US Food and Drug Administration (FDA) has approved the first cell-based gene therapies for the treatment of sickle cell disease (SCD), Casgevy and Lyfgenia. Casgevy, from Vertex Pharmaceuticals and CRISPR Therapeutics, is also the first FDA-approved treatment to use CRISPR gene editing technology.

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Drug Discovery World

SEPTEMBER 20, 2022

SKYSONA has become the first FDA approved therapy to slow the progression of neurologic dysfunction in boys with cerebral adrenoleukodystrophy (CALD). As a condition of the SKYSONA Accelerated Approval, the manufacturer will provide confirmatory long-term clinical data to the FDA.

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Drug Discovery World

JANUARY 12, 2023

The approval by the Food and Drug Administration (FDA) was based on results from the MANDALA and DENALI Phase III trials. . The approval of Airsupra means that for the first time, adults with asthma in the US have a rescue treatment to manage both their symptoms and the inflammatory nature of their disease.” .

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Drug Discovery World

APRIL 6, 2023

The data supporting the EUA were based on the previously announced results of the multicentre Phase III PANAMO trial. The trial is one of the largest 1:1 randomised, double-blind placebo-controlled trials in invasively mechanically ventilated Covid-19 patients in intensive care units.

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Drug Discovery World

FEBRUARY 2, 2023

Orserdu was approved under the FDA’s Priority Review and Fast Track designation based on the results of the registrational Phase III trial EMERALD, that demonstrated statistically significant progression-free survival (PFS) with elacestrant vs. SOC endocrine monotherapy.

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Drug Discovery World

JANUARY 23, 2023

As an FDA-approved oral drug, the side-effects of cladribine are quite manageable and it has been well evaluated for pharmacokinetics. Additionally, the clinical trial period will be considerably shorter than that required for new drug development.

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Drug Discovery World

SEPTEMBER 13, 2022

It is approved in patients who are candidates for systemic therapy or phototherapy, but not recommended in combination with other potent immunosuppressants. The post FDA approves new first-line treatment for plaque psoriasis appeared first on Drug Discovery World (DDW).

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Drug Discovery World

OCTOBER 4, 2022

The approval is the result of a long advocacy campaign to convince the FDA to approve the treatment prior to completion of an ongoing Phase III trial. . “We In June 2016, the Association provided Amylyx, the producer of AMX0035, with a $750,000 grant for a clinical trial pilot.

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Drugs.com

JULY 2, 2024

TUESDAY, July 2, 2024 -- A new drug to treat Alzheimer's disease was approved by the U.S. In clinical trials, donanemab (Kisunla) modestly slowed the pace of thinking declines among patients in the early. Food and Drug Administration on Tuesday.

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Drugs.com

JULY 2, 2024

TUESDAY, July 2, 2024 -- A new drug to treat Alzheimer's disease was approved by the U.S. clinical trials, donanemab (Kisunla) modestly slowed the pace of thinking declines among patients in the early. Food and Drug Administration on Tuesday.In

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The Pharma Data

JUNE 2, 2023

Food and Drug Administration (FDA) for the treatment of adult patients with deleterious or suspected deleterious BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC). Patients should be selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA. In the U.S., For the U.S.

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Drug Discovery World

NOVEMBER 23, 2023

Minoryx has announced enrollment of first patients with cerebral Adrenoleukodystrophy (cALD) in the US Phase III clinical trial, CALYX. This will push the Phase III CALYX trial forward and bring leriglitazone to patients as quickly as possible,” said Sílvia Pascual, VP Clinical Development, Minoryx. “In

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Drug Discovery World

OCTOBER 11, 2023

In August 2023, the US Food and Drug Administration (FDA) approved complement C5 inhibitor Izervay , which is currently the only approved GA treatment with a statistically significant reduction in the rate of GA progression.

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PLOS: DNA Science

MARCH 28, 2024

The New Drug Duvyzat (givinostat), a type of drug called an HDAC inhibitor, has been in clinical trials to treat cancers and other disorders of the blood, Crohn’s disease, and a form of juvenile arthritis. Results from the study that led to the FDA approval appeared in The Lancet Neurology in April 2024 with commentary.

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Drug Discovery World

AUGUST 5, 2024

Peter Marks, Director of the Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER), said the approval of the “state-of-the-art immunotherapy technology” provides a “critical new option for a patient population in need”. The median duration of response was six months.

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Drug Discovery World

SEPTEMBER 2, 2024

The European Commission (EC) has approved Braftovi (encorafenib) in combination with Mektovi (binimetinib) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with a BRAFV600E mutation. The EC decision followw a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) issued on 25 July.

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Drug Discovery World

APRIL 3, 2023

This year, the team will launch a combined Phase I and IIa trial of R805/CX-011 for the treatment of osteoarthritis in patients in collaboration with the start-up Carthronix. They think the drug has the potential to delay or even reduce the need for joint replacement surgery, the only existing FDA-approved therapy for osteoarthritis.

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Drug Discovery World

JULY 14, 2022

Biotech company Actigen has moved closer to clinical trials for rare disease treatment for Hunter syndrome, following a pre-Investigational New Drug (IND) meeting with the US Food and Drug Administration (FDA). ? . Hunter syndrome .

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Drug Discovery World

MARCH 29, 2024

FDA approves Covid-19 mAb for emergency use The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to half-life extended monoclonal antibody (mAb) Pemgarda (pemivibart, or VYD222) for the pre-exposure prophylaxis of Covid-19.

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BioPharma Drive: Drug Pricing

JUNE 4, 2024

A group of independent experts wasn't convinced by clinical trial data from company Lykos Therapeutics, which is seeking FDA approval of MDMA-assisted treatment for post-traumatic stress disorder.

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Drug Discovery World

AUGUST 9, 2024

First engineered cell therapy for a solid tumour gets US approval Adaptimmune Therapeutics’ Tecelra (afamitresgene autoleucel) has become the first engineered cell therapy for a solid tumour cancer approved in the US.

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Drug Discovery World

JUNE 16, 2023

Regulatory approvals and industry guidelines are key to the continued development and discovery of drugs, which is a common theme throughout this week’s news highlights, including an FDA approval for Pfizer, a NICE recommendation for AstraZeneca UK, and an update to the HER2 Breast Cancer Testing Guidelines.

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Science Daily: Pharmacology News

APRIL 15, 2024

Researchers have discovered that an FDA-approved epilepsy drug can prevent or slow the growth of NF1-linked optic gliomas in mice, laying the groundwork for a clinical trial.

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Drug Discovery World

APRIL 2, 2024

DDW’s Megan Thomas narrates five key stories of the week to keep DDW subscribers up-to-date on the latest industry updates.

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The Pharma Data

JUNE 26, 2023

FDA approves Pfizer’s LITFULO™ (ritlecitinib) for adults and adolescents with severe alopecia areata Pfizer Inc. Food and Drug Administration (FDA) has approved LITFULO™ (ritlecitinib), a once-daily oral treatment, for individuals 12 years of age and older with severe alopecia areata. Source link: [link]

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Drug Discovery World

JUNE 27, 2024

Novo Nordisk has announced results from the Phase III FRONTIER2 trial of 254 adults and adolescents aged 12 years and over with haemophilia A, with and without inhibitors. The trial assessed both once-weekly and once-monthly prophylactic treatment with the investigational treatment Mim8. with once-weekly and 98.7%

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