Drug Discovery World

JUNE 28, 2023

Verona Pharma has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for approval of ensifentrine for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

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Drug Discovery World

MARCH 22, 2024

The US Food and Drug Administration (FDA) has approved Tryvio (aprocitentan) for the treatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure in adult patients who are not adequately controlled on other drugs.

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Drug Discovery World

DECEMBER 5, 2023

Eli Lilly’s Jaypirca (pirtobrutinib) has been approved in the US for lymphocytic leukaemia or small lymphocytic lymphoma (CLL/SLL). Jaypirca is the first FDA-approved non-covalent (reversible) BTK inhibitor.

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Drug Discovery World

JANUARY 23, 2023

Researchers have discovered a clinical drug that sensitises glioblastoma (GBM) cells to radiotherapy and could replace the current standard of care. In addition, they discovered that cladribine, a clinical drug, activates DGKB and inhibits DGAT1. GBM is a WHO grade IV brain tumour with dismal prognosis.

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Drug Discovery World

DECEMBER 20, 2023

The US Food and Drug Administration (FDA) has approved antibody-drug conjugate (ADC) enfortumab vedotin-ejfv (Padcev) in combination with pembrolizumab (Keytruda) for patients with locally advanced or metastatic urothelial cancer (la/mUC).

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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

AUGUST 21, 2023

Ipsen’s Sohonos (palovarotene) has become the first drug approved for patients with fibrodysplasia ossificans progressiva (FOP) in the US, following the granting of a marketing authorisation by the Food and Drug Administration (FDA). The EU’s regulator chose not to recommend the drug in January 2023.

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Drug Discovery World

JUNE 6, 2023

The US Food and Drug Administration (FDA) has approved Pfizer’s bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine Abrysvo in individuals 60 years and older. The post FDA approves first vaccine for respiratory syncytial virus appeared first on Drug Discovery World (DDW).

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Drug Discovery World

APRIL 4, 2024

The US Food and Drug Administration (FDA) has approved Vafseo (vadadustat) Tablets for the treatment of anaemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months.

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Drug Discovery World

AUGUST 23, 2023

The US Food and Drug Administration (FDA) has approved the first vaccine for pregnant individuals to prevent respiratory syncytial virus (RSV) in infants. The FDA approved Abrysvo in May for the prevention of LRTD caused by RSV in individuals 60 years of age and older.

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Drug Discovery World

MARCH 26, 2024

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 (prevention) of Covid-19.

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Drug Discovery World

DECEMBER 1, 2023

SpringWorks Therapeutics’ Ogsiveo (nirogacestat) has become the first drug to be approved for desmoid tumours in the US, following the go-ahead from the US Food and Drug Administration (FDA). Today’s approval will offer the first approved treatment option for patients beyond surgery and radiation.”

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Drug Discovery World

JULY 20, 2023

The US Food and Drug Administration (FDA) has granted marketing authorisations to several new therapeutics over the last month that will have a significant impact on areas of unmet need and the evolution of future treatments.

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Drug Discovery World

JULY 25, 2023

The US Food and Drug Administration (FDA) has approved Daiichi Sankyo’s quizartinib (Vanflyta) for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) that is FLT3 internal tandem duplication (ITD)-positive.

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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). The post FDA approves gene therapy for rare neurological disorder appeared first on Drug Discovery World (DDW).

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Crown Bioscience

JUNE 6, 2024

In a significant development, the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) approved 55 new drugs in 2023.

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Drug Discovery World

MAY 29, 2023

The US Food and Drug Administration has approved Krystal Biotech’s Vyjuvek, a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy, for the treatment of dystrophic epidermolysis bullosa (DEB). The post FDA approves first gene therapy for rare skin disorder appeared first on Drug Discovery World (DDW).

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Drug Discovery World

JUNE 12, 2023

The US Food and Drug Administration (FDA) has approved Minoryx Therapeutics’ Phase III clinical trial (CALYX) of leriglitazone, to treat adult male X-linked Adrenoleukodystrophy (X-ALD) patients with cerebral Adrenoleukodystrophy (cALD).

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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

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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Drugs.com

JULY 2, 2024

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

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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. Food and Drug Administration on Tuesday. In clinical trials, donanemab (Kisunla) modestly slowed the pace of thinking declines among patients in the early.

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Drug Discovery World

AUGUST 23, 2024

The top stories: FDA approves Niktimvo for chronic graft-versus-host disease The US Food and Drug Administration (FDA) has approved axatilimab-csfr (Niktimvo), a colony stimulating factor-1 receptor-blocking antibody, for the treatment of chronic graft-versus-host disease (cGVHD).

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Drug Discovery World

FEBRUARY 2, 2023

The first and only treatment specifically indicated for patients with ESR1 mutations in ER+, HER2- advanced or metastatic breast cancer has been approved in the US.

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Drugs.com

AUGUST 22, 2024

22, 2024 -- Updated shots to shield against COVID-19 infection were approved by the U.S. Food and Drug Administration on Thursday.This year's approval for the updated mRNA vaccines comes much sooner than happened in 2023, when fall. THURSDAY, Aug.

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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

Gohibic (vilobelimab) has been granted an Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for the treatment of Covid-19 in hospitalised adults. The post FDA approves Gohibic for emergency use in Covid-19 patients appeared first on Drug Discovery World (DDW).

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Drug Patent Watch

JULY 24, 2024

In the high-stakes world of pharmaceuticals, generic drugs have become the unsung heroes of healthcare accessibility. These cost-effective alternatives to […] Source

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Drug Discovery World

OCTOBER 4, 2022

The US Food and Drug Administration (FDA) has granted approval to AMX0035, a new treatment for people living with amyotrophic lateral sclerosis (ALS). Development of the drug was funded by $2.2 The Association is currently funding 40 potential treatments in the drug development pipeline.

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BioPharma Drive: Drug Pricing

AUGUST 12, 2024

The clearance of Yorvipath for hypoparathyroidism was some time coming for Ascendis, which had resubmitted after receiving a rejection last year.

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SCIENMAG: Medicine & Health

OCTOBER 31, 2023

— A new drug developed by professors from the School of Pharmacy and Pharmaceutical Sciences at Binghamton University has received Food and Drug Administration (FDA) approval for the treatment of patients with Duchenne muscular dystrophy (DMD), a common genetic disease that mostly affects young boys.

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Drug Discovery World

SEPTEMBER 13, 2022

The US Food and Drug Administration (FDA) has approved Bristol Myers Squibb’s allosteric tyrosine kinase 2 inhibitor Sotyktu (deucravacitinib) for the treatment of adults with moderate-to-severe plaque psoriasis. 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

NOVEMBER 21, 2022

The US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for anti-CD3-directed antibody TZIELD (teplizumab-mzwv), the first immunomodulatory treatment for type 1 diabetes (T1D). . The company also offers financial assistance options to eligible patients for out-of-pocket costs. . .

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Drugs.com

MAY 17, 2024

Food and Drug Administration on Thursday approved a new drug to treat patients with an advanced form of deadly lung cancer. FRIDAY, MAY 17, 2024 -- The U.S. Importantly, tarlatamab (Imdelltra) is only for patients who have exhausted all other.

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BioPharma Drive: Drug Pricing

MARCH 14, 2024

But its sales potential is unclear, and competition could emerge from popular weight loss drugs. Rezdiffra’s clearance is a turning point in the fight against the liver disease.

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Drugs.com

MAY 17, 2024

Food and Drug Administration on Thursday approved a new drug to treat patients with an advanced form of deadly lung cancer. FRIDAY, MAY 17, 2024 -- The U.S. Importantly, tarlatamab (Imdelltra) is only for patients who have exhausted all other.

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Drugs.com

JULY 29, 2024

Food and Drug Administration on Monday approved a new blood test that can spot colon cancer.In late May, an FDA advisory panel had voted 7-2 that the benefits outweigh the risks when using the Guardant Health's. MONDAY, July 29, 2024 -- The U.S.

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