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

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

JANUARY 25, 2024

The US Food and Drug Administration (FDA) has granted Orphan Drug Designation to Pleco Therapeutics’s lead compound PTX-252 for the treatment of acute myeloid leukaemia (AML). The FDA’s designation acknowledges the potential of PTX-252 in addressing AML, a rare blood cancer with a poor prognosis.

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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

JUNE 23, 2023

The Food and Drug Administration (FDA) has granted accelerated approval to Elevidys (delandistrogene moxeparvovec-rokl), an adeno-associated virus (AAV) based gene therapy for the treatment of DMD. The post FDA approves first gene therapy for Duchenne muscular dystrophy appeared first on Drug Discovery World (DDW).

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Drug Discovery World

FEBRUARY 19, 2024

Amtagvi is the first FDA-approved tumour-derived T cell immunotherapy. The post FDA approves first T cell therapy in solid tumours appeared first on Drug Discovery World (DDW). Additional expansion at iCTC is underway, according to the company, which will significantly increase this capacity over the next few years.

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Drug Discovery World

AUGUST 11, 2023

The US Food and Drug Administration (FDA) has approved Izervay (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The FDA approval of Izervay is great news for the retina community and our patients suffering from GA.” GA impacts an estimated 1.5

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Drug Discovery World

JANUARY 10, 2024

Speaking on the recent FDA statement, Bruce Levine, ISCT Immediate Past President and Lead Author on the publication, stated: “The fundamental question from this report is whether or not there is a causal link between CAR-T therapy and these rare T cell malignancy cases and in how many patients.

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Drug Discovery World

OCTOBER 4, 2023

The US Food and Drug Administration (FDA) has accepted Rocket Pharmaceuticals’ Biologics License Application (BLA) and granted Priority Review for RP-L201 (marnetegragene autotemcel). The post FDA acceptance advances investigational gene therapy appeared first on Drug Discovery World (DDW).

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Drug Discovery World

OCTOBER 3, 2023

The US Food and Drug Administration (FDA) has announced a pilot programme with the aim of accelerating the development of novel drug and biological products for rare diseases. The FDA will be accepting applications to the START programme between 2 January 2024 and 1 March 2024.

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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

MARCH 6, 2024

UK-based biotech SynaptixBio has secured a second Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA). The post FDA Orphan Drug Designation awarded to rare disease therapies appeared first on Drug Discovery World (DDW).

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Drug Discovery World

JUNE 30, 2023

AC Immune has received Fast Track designation from the US Food and Drug Administration (FDA) for its anti-amyloid beta (Abeta) active immunotherapy (vaccine)-candidate, ACI-24.060, for treatment of Alzheimer’s disease (AD). To read this content in full, you need to login. Not yet a DDW member? Join now for FREE – it takes less than 2 minutes!

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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). The post FDA approves first therapy for rare non-cancerous tumours appeared first on Drug Discovery World (DDW).

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Drug Discovery World

OCTOBER 27, 2023

The US Food and Drug Administration (FDA) has granted clearance for Endogena’s Investigational New Drug (IND) application for EA 2351, a potential treatment for geographic atrophy (GA). The post FDA gives green light for AMD treatment trials appeared first on Drug Discovery World (DDW).

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Drug Discovery World

JUNE 27, 2023

The US Food and Drug Administration (FDA) has published new draft guidance to highlight fundamental considerations to researchers investigating the use of psychedelic drugs for the potential treatment of medical conditions, including psychiatric or substance use disorders.

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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. The FDA also approved LeukoStrat CDx FLT3 Mutation Assay as a companion diagnostic for Vanflyta.

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Drugs.com

MARCH 6, 2024

The FDA urged folks to throw away and not buy the following brands of. WEDNESDAY, March 6, 2024 -- The U.S. Food and Drug Administration issued a health advisory Wednesday warning consumers that six brands of ground cinnamon are tainted with lead.

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Drug Discovery World

APRIL 4, 2023

The Food and Drug Administration (FDA) in the US has made several key drug decisions over the last few weeks. The drug was granted orphan drug designation by the FDA in May 2021. Here’s a summary.

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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 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). It affects an estimated 400 people in the US and 900 people globally.

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Drug Discovery World

OCTOBER 3, 2023

It features Ruth Roberts and Michael Morton, co-founders of ApconiX, and Dr Kimberly Rockley, ApconiX, who discuss novel alternative methods and the impact of the FDA Modernisation Act 2.0 The post Podcast: The FDA Modernisation Act 2.0 and seizure liability testing appeared first on Drug Discovery World (DDW).

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Drug Discovery World

SEPTEMBER 27, 2023

The US Food and Drug Administration (FDA) has granted fast track designation to Mythic Therapeutics’ investigational cMET-targeting ADC, MYTX-011, for the treatment of patients with non-small cell lung cancer (NSCLC) with cMET overexpression.

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Drug Discovery World

AUGUST 18, 2023

The US Food and Drug Administration (FDA) has granted accelerated approval to Pfizer’s Elrexfio (elranatamab-bcmm) for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM).

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Drug Discovery World

MAY 23, 2023

The US Food and Drug Administration (FDA) Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) have voted eight to six in favour of a new gene therapy for Duchenne muscular dystrophy. The CTGTAC’s vote will be considered by the FDA when making its decision regarding the potential accelerated approval of SRP-9001.

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Drug Discovery World

JULY 21, 2023

Madrigal Pharmaceuticals has submitted an application for resmetirom, a drug for nonalcoholic steatohepatitis (NASH) with liver fibrosis, to the US Food and Drug Administration (FDA) and has requested a priority review. The post First drug for NASH with liver fibrosis submitted to FDA appeared first on Drug Discovery World (DDW).

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Drug Discovery World

DECEMBER 2, 2022

The US Food and Drug Administration (FDA) has accepted Sarepta Therapeutics’ Biologics License Application (BLA) seeking accelerated approval of SRP-9001 (delandistrogene moxeparvovec) for the treatment of ambulant individuals with Duchenne muscular dystrophy. .

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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

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

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

APRIL 7, 2023

Sequana Medical has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for its second-generation DSR product (DSR 2.0) The final study design of the randomised controlled Phase I/IIa MOJAVE study in the US will be communicated upon approval by the FDA and Ethics Committees.

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Drug Discovery World

JANUARY 6, 2023

The United States Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to Bicycle Therapeutics’ BT8009 monotherapy for the treatment of adult patients with previously treated locally advanced or metastatic urothelial cancer. .

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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

SEPTEMBER 29, 2023

The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to Calliditas Therapeutics for the treatment of Alport syndrome with setanaxib. References [link] The post FDA orphan drug designation for Alport syndrome with setanaxib appeared first on Drug Discovery World (DDW).

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Drug Discovery World

AUGUST 31, 2023

The US Food and Drug Administration (FDA) has expanded the use of Bristol Myers Squibb’s Reblozyl (luspatercept-aamt) to include first-line treatment of anaemia in adults with lower-risk myelodysplastic syndromes (MDS).

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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

MAY 12, 2023

The Food and Drug Administration (FDA) has approved the companies’ supplemental New Drug Application (sNDA). 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.

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