Drug Discovery World

DECEMBER 20, 2023

Ahsan Arozullah, Senior Vice President, Head of Oncology Development, Astellas, commented: “Today’s FDA approval represents a paradigm change in the treatment of advanced bladder cancer. ” The post FDA-approved bladder cancer therapy reduces risk of death by 50% appeared first on Drug Discovery World (DDW).

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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

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

JUNE 6, 2023

Today’s FDA approval of Abrysvo recognises significant scientific progress, and importantly helps provide older adults potential protection against RSV and an opportunity to improve community health by helping prevent the disease.”

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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

DECEMBER 1, 2023

This approval represents an important therapeutic advance for patients,” said Mrinal M Gounder, sarcoma medical oncologist at Memorial Sloan Kettering Cancer Center (MSK) in New York City and an investigator in the DeFi trial. 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

JULY 25, 2023

The post FDA approves quizartinib for acute myeloid leukaemia appeared first on Drug Discovery World (DDW). Quizartinib is available only through a restricted programme under a Risk Evaluation and Mitigation Strategy (REMS), called the Vanflyta REMS.

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Drug Discovery World

JULY 20, 2023

The FDA granted accelerated approval to the adeno-associated virus (AAV) based gene therapy for the treatment of ambulatory paediatric patients aged four through five years with DMD with a confirmed mutation in the DMD gene based on expression of Elevidys micro-dystrophin.

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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. The post FDA approves first drug for agitation due Alzheimer’s dementia appeared first on Drug Discovery World (DDW).

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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 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

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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Drug Discovery World

JUNE 28, 2023

The post Verona Pharma submits COPD drug ensifentrine for US FDA approval appeared first on Drug Discovery World (DDW). The NDA contains data from the positive Phase III ENHANCE studies and other ensifentrine clinical studies including data from approximately 3,000 subjects.

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Drug Discovery World

MAY 15, 2023

The post FDA approves study into CAR-T associated cytokine storm appeared first on Drug Discovery World (DDW). “We are excited to support the acceleration of CytoAgents’ clinical development efforts and look forward to generating meaningful clinical data in patients.”

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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. The post FDA-approved drug sensitises brain cancer cells to radiotherapy appeared first on Drug Discovery World (DDW).

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Drug Discovery World

JUNE 12, 2023

” The post FDA approves Phase III cerebral Adrenoleukodystrophy trial appeared first on Drug Discovery World (DDW).

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Drug Discovery World

JANUARY 12, 2023

“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.” . The post FDA approves first rescue medication to manage asthma inflammation appeared first on Drug Discovery World (DDW).

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Drug Discovery World

APRIL 6, 2023

The post FDA approves Gohibic for emergency use in Covid-19 patients appeared first on Drug Discovery World (DDW). Our Covid-19 results underscore the anti-inflammatory potential of inhibition of the terminal C5a and C5a receptor pathway in other inflammatory diseases.”

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Drug Discovery World

SEPTEMBER 13, 2022

The post FDA approves new first-line treatment for plaque psoriasis appeared first on Drug Discovery World (DDW). Sotyktu is expected to be available to patients in the US in September 2022.

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Drug Discovery World

OCTOBER 4, 2022

The post ‘Ice Bucket Challenge’ funds FDA-approved ALS treatment appeared first on Drug Discovery World (DDW). Since the Ice Bucket Challenge, the ALS Association has spent over $127 million on ALS research and is currently funding 130 research projects in 12 countries.

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Drug Discovery World

NOVEMBER 21, 2022

The post FDA approves first disease-modifying therapy for type 1 diabetes appeared first on Drug Discovery World (DDW). Provention Bio has launched COMPASS, a patient support program to answer questions and help navigate coverage, reimbursement and access for patients that are prescribed TZIELD.

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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.

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Drugs.com

MAY 15, 2024

Food and Drug Administration has approved a kit that will allow women to collect their own vaginal sample for HPV screening, a move that could increase early detection in those at risk for cervical cancer. WEDNESDAY, May 15, 2024 -- The U.S.

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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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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. BINGHAMTON, N.Y.

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Metabolite Tales Blog

APRIL 10, 2024

link] The post Metabolism of 2023 FDA Approved Small Molecules – PART 2 appeared first on Hypha Discovery. Evolution of Ritlecitinib Population Pharmacokinetic Models During Clinical Drug Development. Clin Pharmacokinet. 2023; 62(12):1765-1779.

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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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PLOS: DNA Science

MARCH 28, 2024

Results from the study that led to the FDA approval appeared in The Lancet Neurology in April 2024 with commentary. The post FDA Approves Duvystat, New Oral Treatment for Duchenne Muscular Dystrophy (DMD) appeared first on DNA Science.

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Drugs.com

APRIL 25, 2024

Food and Drug Administration on Wednesday approved Pivya (pivmecillinam) to. THURSDAY, April 25, 2024 -- As many patients already know, urinary tract infections (UTIs) can recur despite the use of antibiotics.So, it's welcome news that the U.S.

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Drugs.com

APRIL 25, 2024

Food and Drug Administration on Wednesday approved Pivya (pivmecillinam) to. THURSDAY, April 25, 2024 -- As many patients already know, urinary tract infections (UTIs) can recur despite the use of antibiotics. So, it's welcome news that the U.S.

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BioPharma Drive: Drug Pricing

MARCH 14, 2024

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

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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

MARCH 8, 2024

FRIDAY, March 8, 2024 -- Wegovy (semaglutide), the weight-loss version of blockbuster diabetes drug Ozempic, was approved on Friday by the U.S. Food and Drug Administration to help prevent heart attack, stroke and heart death.“Wegovy Wegovy is now the.

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Drugs.com

SEPTEMBER 11, 2023

MONDAY, Sept. 11, 2023 -- The U.S. Food and Drug Administration on Monday gave the green light to new COVID boosters for Americans, setting the stage for the updated vaccines to become available within days. The COVID-19 shots from Pfizer and.

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BioPharma Drive: Drug Pricing

MARCH 28, 2024

The agency gave Akebia’s drug an OK after receiving more safety data, but imposed a strict boxed warning for its use that may limit uptake.

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BioPharma Drive: Drug Pricing

MARCH 26, 2024

Merck is couting on Winrevair, which it acquired by buying Acceleron Pharma, to help soften the blow when Keytruda loses patent protection later this decade.

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BioPharma Drive: Drug Pricing

MARCH 15, 2024

The company expects initial uptake of Rezdiffra, which costs $47,400 per year, to be slow as doctors and insurers establish the protocols needed to find patients eligible for treatment.

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