Drug Discovery World

DECEMBER 5, 2023

It has been granted approval by the Food and Drug Administration (FDA) to treat patients who have received at least two lines of therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor and a BCL-2 inhibitor. Jaypirca is the first FDA-approved non-covalent (reversible) BTK inhibitor.

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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

AUGUST 21, 2023

FOP is a rare, autosomal dominant disease where connective tissue such as muscle, tendons and ligaments gradually turn into bone tissue, causing limited movement, deformities and severe disability. Sohonos received a priority review, fast track designation and breakthrough therapy designation from the FDA for this indication.

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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.

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Drug Discovery World

MAY 12, 2023

Otsuka and Lundbeck’s Rexulti (brexpiprazole) has become the first pharmacological treatment to be approved in the US for agitation associated with dementia due to Alzheimer’s disease. The Food and Drug Administration (FDA) has approved the companies’ supplemental New Drug Application (sNDA).

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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

MARCH 22, 2024

.” Martine Clozel, MD and Chief Scientific Officer of Idorsia, concluded: “After more than 30 years working in the field of endothelin science, our research has brought about changes in the treatment paradigm of several cardiovascular diseases.

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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

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

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.

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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). CALD is a rare, progressive, neurodegenerative disease that primarily affects young boys and causes irreversible, devastating neurologic decline.

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Drug Discovery World

APRIL 6, 2023

Professor Niels C Riedemann, CEO and Founder of InflaRx, said: “Despite the availability of vaccines and other treatments for earlier disease stages of Covid-19, many patients are still developing viral sepsis and are progressing to critical status, which often requires invasive mechanical ventilation.

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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. Psoriasis is a widely prevalent, immune-mediated disease that affects approximately 7.5 million people in the US, of which, up to 90% have plaque psoriasis.

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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

FEBRUARY 2, 2023

The approval of elacestrant is welcomed as it offers a novel option for patients with ER+, HER2- metastatic breast cancer. The approval of elacestrant is welcomed as it offers a novel option for patients with ER+, HER2- metastatic breast cancer.

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Drug Discovery World

NOVEMBER 14, 2023

DDW’s Megan Thomas looks at how different diseases will benefit from the success of therapeutic antibodies. What is particularly noteworthy when it comes to the mAbs being developed and approved for Covid-19 is drug repurposing, showing the scope of future treatments with mAbs. The work is continuous for this disease target.

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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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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

BI 771716 is a highly specific antibody fragment of reduced size, enabling an optimised penetration through all retinal layers to the most critical target site driving GA disease pathology. GA is an irreversible retinal disease that occurs in people with late-stage dry age-related macular degeneration (AMD).

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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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PLOS: DNA Science

MARCH 28, 2024

A new drug has entered the arsenal against Duchenne muscular dystrophy (DMD), a genetic disease that affects boys and is challenging to treat. FDA classifies it as a “nonsteroidal treatment” – not a gene therapy, but it affects gene expression. ITF Therapeutics provides the new drug in the US. Hyperbole or Hope?

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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 7, 2023

It’s been a fascinating week in drug discovery, as AstraZeneca announced that its Phase III trial of datopotamab deruxtecan did not meet its second primary endpoint and saw an 8% drop in its stock market value as a result.

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Drug Discovery World

MARCH 8, 2024

The US Food and Drug Administration (FDA) has revealed plans to convene a meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) to discuss the Phase III TRAILBLAZER-ALZ 2 trial. The trial evaluated the efficacy and safety of Eli Lilly’s donanemab in early symptomatic Alzheimer’s disease.

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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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Drug Discovery World

JUNE 10, 2024

The US Food and Drug Administration (FDA) has approved mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection. The primary analysis with 3.7

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Drug Discovery World

MAY 1, 2024

AI’s significance is also evident in the science, where immuno-oncology company Aulos Bioscience recently revealed interim results from an ongoing Phase I/II trial of an AI-designed monoclonal antibody (mAb), AU-007, in solid tumours. Research will likely focus on expanding applications in infectious diseases and autoimmune disorders.”

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Chemical Biology and Drug Design

OCTOBER 10, 2023

Abstract Human immunodeficiency virus (HIV) causes acquired immunodeficiency syndrome (AIDS), a lethal disease that is prevalent worldwide. Later, a new type of non-nucleoside reverse transcriptase inhibitors (NNRTIs) were approved as anti-HIV drugs. Molecular insights of HIV Reverse transcriptase and it's inhibitors.

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Drug Discovery World

OCTOBER 4, 2022

William Erhardt , President, Head of Development & Operations of biotech Oligomerix, tells Lu Rahman about the company’s differentiated approach to developing disease-modifying therapeutics for neurodegenerative diseases. . With its recent award of $3.35 Overcoming sector challenges .

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Drug Discovery World

OCTOBER 18, 2023

Adeno-associated virus (AAV) vector-based gene therapies hold exceptional promise across a range of disease areas. We’re beginning to see their potential come to fruition, with the FDA having approved three treatments as of January 2023 — for retinal dystrophy 1 spinal muscular atrophy, 2 and haemophilia B.

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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 6, 2024

Professor Charles Swanton, Cancer Research UK’s chief clinician, said the melanoma trial results were “extremely impressive”, adding: “The new vaccine approach is another piece of the puzzle that will allow more patients to be cured, hopefully, or fewer patients to suffer disease relapse. months after initial treatment.

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Drug Discovery World

JULY 31, 2023

President and Chief Executive Officer Christopher Viehbacher said: “In the second quarter, Biogen continued to advance ground-breaking science with the FDA approval of two first-in-class therapies for Alzheimer’s disease and ALS, while also delivering on our base business expectations. Biogen’s business is in transition.

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Drug Discovery World

APRIL 4, 2023

Orserdu (elacestrant), Stemline Therapeutics The first and only treatment specifically indicated for patients with ESR1 mutations in ER+, HER2- advanced or metastatic breast cancer was approved in the US in February. This made Jesduvroq is the first oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) to be approved in the US.

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The Pharma Data

AUGUST 7, 2021

Approval is based on positive Phase 3 data demonstrating improvements in key disease burden measures and establishing its safety profile Nexviazyme specifically targets the M6P receptor, the key pathway for enzyme replacement therapy, to effectively clear glycogen build-up in muscle cells.

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Drug Discovery World

MARCH 1, 2024

Pepaxto associated with increased risk of death The FDA is alerting patients and health care professionals that a clinical trial (OCEAN, Study OP-103) evaluating Pepaxto with dexamethasone showed an increased risk of death. The FDA has now suspended enrolment in all ongoing Pepaxto clinical trials.

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