Pharmaceutical Technology

AUGUST 12, 2022

The latest approval was based on the findings from the Phase II DESTINY-Lung02 clinical trial, which assessed the safety and efficacy of two doses of Enhertu in HER2 mutant metastatic NSCLC patients. . In the trial, 1.9% According to the interim efficacy data from a pre-specified patient cohort, a 5.4

FDA Approval 264

FDA Approval Clinical Trials Clinical Trials Engineer 264

Pharmaceutical Technology

JUNE 9, 2023

Findings from the long-term extension ESSENCE-2 OLE trial showed that CyclASol’s effect was maintained and improved for most endpoints over a treatment period of 52 weeks. Novaliq medical science and regulatory affairs vice-president Sonja Krösser stated: “We are proud that the FDA approved VEVYE.

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FDA Approval Bioavailability Containment Drugs 246

Pharmaceutical Technology

MAY 23, 2023

The US Food and Drug Administration (FDA) has granted approval for Blueprint Medicines’ Ayvakit (avapritinib) as the first and only treatment for indolent systemic mastocytosis (ISM) in adult patients. The regulatory approval was based on the data obtained from the placebo-controlled, double-blind PIONEER trial.

FDA Approval 246

FDA Approval Medicine Trials Drugs 246

Pharmaceutical Technology

FEBRUARY 2, 2023

The regulatory approval is based on the data obtained from the ASCEND-D trial, which is evaluating Jesduvroq’s safety and efficacy to treat patients. The ASCEND programme included five Phase III trials that enrolled more than 8,000 patients who received treatment for up to 4.26 dL) for the patients.

FDA Approval 264

FDA Approval Life Science Genetics Trials 264

Pharmaceutical Technology

APRIL 27, 2023

Seres president and CEO Eric Shaff said: “Seres has led the development of microbiome therapeutics, and today’s FDA approval of Vowst as the first orally administered microbiota-based therapeutic for the prevention of recurrent C difficile infection marks a tremendous milestone for the patient community, and for Seres.

FDA Approval 246

FDA Approval Regulation Trials Development 246

AuroBlog - Aurous Healthcare Clinical Trials blog

JANUARY 10, 2023

The US Food and Drug Administration (FDA) on Friday approved a highly anticipated new drug designed to slow cognitive decline in patients in mild and early stages of Alzheimer’s disease.

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FDA Approval Drugs Clinical Trials Clinical Trials 196

Pharmaceutical Technology

FEBRUARY 20, 2023

The regulatory approval is based on positive data obtained from the Phase III OAKS and DERBY trials, which were conducted across a broad and representative population of GA patients. The post US FDA approves Apellis’ geographic atrophy therapy Syfovre appeared first on Pharmaceutical Technology.

FDA Approval 246

FDA Approval Trials Drugs 246

Pharmaceutical Technology

MARCH 13, 2023

It increased the branching of dendrites and synaptic plasticity signals in animal trials. Daybue is claimed to be the first and only drug to receive approval to treat Rett syndrome, a complex, rare neurodevelopmental disorder that affects 6,000 to 9,000 patients in the US.

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FDA Approval Trials Drugs 182

Pharmaceutical Technology

JANUARY 30, 2023

Eli Lilly and Company ’s (Lilly) oncology unit Loxo@Lilly has secured the US Food and Drug Administration (FDA) approval for Jaypirca (pirtobrutinib) to treat relapsed or refractory mantle cell lymphoma (MCL). Lilly stated that the continued approval of Jaypirca for this indication is based on clinical benefit in a confirmatory trial.

FDA Approval 147

FDA Approval Trials Drugs Development 147

XTalks

APRIL 3, 2024

Related: Novartis’ Fabhalta Gets FDA Approval for Rare Complement Blood Disorder The FDA’s green light for Voydeya comes three months after the Japanese Ministry of Health, Labour and Welfare (JHLW) became the first regulator in the world to back the therapy. AstraZeneca is also venturing into cell therapy and genetic medicine.

FDA Approval 102

FDA Approval Sales Trials Development 102

Fierce Pharma

MARCH 15, 2024

Merck's Keytruda excels in cervical cancer trial, showing an ability to extend lives. Will a broader FDA approval follow? kdunleavy Fri, 03/15/2024 - 10:33

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FDA Approval Trials 59

Pharmaceutical Technology

FEBRUARY 13, 2023

Pfizer has received the US Food and Drug Administration (FDA) approval for its supplemental New Drug Application (sNDA) for Cibinqo (abrocitinib) to treat a type of atopic dermatitis (AD). The label expansion for Cibinqo was supported by the data obtained from the placebo-controlled, randomised Phase III JADE TEEN clinical trial.

FDA Approval 147

FDA Approval Trials Clinical Trials Clinical Trials 147

Fierce Pharma

OCTOBER 25, 2023

Five months after becoming the first company to secure FDA approval for a respiratory syncytial virus (RSV) vaccine, GSK is taking steps toward expanding its label for Arexvy.

FDA Approval 104

FDA Approval Vaccination Vaccine Trials 104

Pharmaceutical Technology

AUGUST 8, 2022

The approval was based on findings from the international, randomised, open-label Phase III DESTINY-Breast04 clinical trial. Furthermore, Enhertu’s safety profile was in line with prior clinical trials without any new safety concerns detected. Enhertu-treated subjects had a median overall survival (OS) of 23.4

FDA Approval 264

FDA Approval HR Clinical Trials Clinical Trials 264

Pharmaceutical Technology

JULY 8, 2022

In a Phase III ExteNET clinical trial, neratinib offered a 34% decline in the risk of recurrence and a 2.3% The trial demonstrated that after a median follow-up of 5.2 The post Specialised Therapeutics’ breast cancer drug gets Philippines FDA approval appeared first on Pharmaceutical Technology.

FDA Approval 246

FDA Approval HR Drugs Hormones 246

Pharmaceutical Technology

JUNE 14, 2023

Ipsen has received US Food and Drug Administration (FDA) approval for Bylvay (odevixibat) to treat patients aged 12 months and above with cholestatic pruritus caused by Alagille syndrome (ALGS).

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FDA Approval Genetics Trials Medicine 130

Pharmaceutical Technology

FEBRUARY 9, 2023

Until now, the only FDA-approved treatment in common use was laser photocoagulation, a complex and lengthy procedure that permanently ablates retina tissue and is stressful not only for infant patients but also for the family navigating a delicate time after preterm birth.

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FDA Approval Trials Development Drugs 130

Bio Pharma Dive

FEBRUARY 20, 2024

The FDA approved the targeted therapy together with chemo for first-line metastatic lung cancer, while fresh trial results supported earlier use.

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Trials FDA Approval Drugs 148

Pharmaceutical Technology

MAY 11, 2023

The submission of sNDA was based on the data obtained from two placebo-controlled, double-blind, fixed-dose, randomised 12-week Phase III trials. The trials assessed the frequency of agitation symptoms in Alzheimer’s dementia patients, based on the Cohen-Mansfield agitation inventory (CMAI) total score.

FDA Approval 147

FDA Approval Trials Regulation Drugs 147

Pharmaceutical Technology

SEPTEMBER 11, 2023

The US FDA has awarded Biosyngen’s IND for the T-cell receptor therapy, BRL03, to start Phase I/II trials in lung and other solid cancers.

FDA Approval 130

FDA Approval Trials 130

Bio Pharma Dive

JANUARY 6, 2023

The agency’s approval comes months after a large clinical trial showed the drug, called Leqembi, could slow the disease’s progression. Yet experts have raised concerns about its safety.

FDA Approval 341

FDA Approval Clinical Trials Clinical Trials Drugs 341

XTalks

DECEMBER 12, 2023

After receiving US Food and Drug Administration (FDA) approval for Fabhalta (iptacopan) last week for the treatment of the rare blood disorder paroxysmal nocturnal hemoglobinuria (PNH), Novartis presented trial data yesterday showing the drug’s promise in another indication.

FDA Approval 95

FDA Approval Bacteria Trials Protein 95

Pharmaceutical Technology

MAY 23, 2023

Indivior CEO Mark Crossley said: “Opvee’s FDA approval represents a significant achievement in the development of new treatment options to address today’s era of opioid overdoses that are driven by powerful synthetic opioids such as fentanyl. and five minutes.

FDA Approval 130

FDA Approval Trials Marketing Development 130

JAMA Internal Medicine

FEBRUARY 12, 2023

This cross-sectional study determines the frequency of and rationale for US Food and Drug Administration (FDA) approval of drugs not meeting pivotal trial primary efficacy end points.

FDA Approval 76

FDA Approval Trials Drugs 76

XTalks

NOVEMBER 30, 2023

Pfizer spinout SpringWorks Therapeutics’ Ogsiveo (nirogacestat) has received US Food and Drug Administration (FDA) approval for the treatment of desmoid tumors, an ultra-rare subtype of non-cancerous soft tissue sarcomas that can cause severe pain and disfigurement.

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FDA Approval Trials Clinical Trials Clinical Trials 101

Pharmaceutical Technology

FEBRUARY 24, 2023

The regulatory approval is supported by the data obtained from the pivotal Phase III XTEND-1 trial. The trial evaluated the pharmacokinetics, efficacy, and safety of once-a-week ALTUVIIIO in people aged 12 years or above living with severe haemophilia A. Earlier, they received treatment with factor VIII replacement therapy.

FDA Approval 147

FDA Approval Protein Trials Drugs 147

XTalks

JANUARY 2, 2024

For instance, Vyjuvek , the first FDA-approved gene therapy for DEB, is priced at $24,250 per vial. Safety and Efficacy of Filsuvez The FDA’s approval of Filsuvez is supported by compelling clinical evidence. Specifically, 41.3 percent observed in the control gel arm. percent of cases.

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FDA Approval Gene Therapy Gene Trials 111

Pharmaceutical Technology

MARCH 27, 2023

It is claimed to be the first and only therapy to receive approval in the US for the treatment of APDS, a rare and progressive primary immunodeficiency. After assessing the New Drug Application (NDA) under priority review, the FDA granted the approval based on the data obtained from a Phase II/III clinical trial.

FDA Approval 130

FDA Approval Clinical Trials Clinical Trials Medicine 130

Pharmaceutical Technology

JANUARY 12, 2023

The regulatory approval was based on the data obtained from the Phase III MANDALA and DENALI trials. Airsupra significantly reduced severe exacerbations risk compared to albuterol in moderate to severe asthma patients in the MANDALA trial.

FDA Approval 130

FDA Approval Trials Development Drugs 130

Pharmaceutical Technology

JUNE 1, 2023

The US Food and Drug Administration (FDA) has granted a combination of AstraZeneca and MSD ’s Lynparza (olaparib), with standard therapies for treating BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Safety and tolerability were in line with that observed in prior trials and the known profiles of the medicines.

FDA Approval 244

FDA Approval Hormones Trials Clinical Trials 244

Pharmaceutical Technology

SEPTEMBER 5, 2022

Earlier, the therapy had obtained FDA approval for usage in CF patients aged two years and above with two F508del mutation copies. The latest approval for use in children aged 12 to below 24 months is based on an open-label, multicentre Phase III clinical trial for 24 weeks.

FDA Approval 130

FDA Approval Genotype Clinical Trials Clinical Trials 130

XTalks

MARCH 28, 2024

Italy-based drugmaker Italfarmaco has won US Food and Drug Administration (FDA) approval for its oral medication Duvyzat (givinostat) for the treatment of Duchenne muscular dystrophy (DMD) in patients six years of age and older. The study is one of the largest DMD Phase III trials to date. million last year, of which $131.3

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FDA Approval Genetics Gene Therapy Gene 105

XTalks

JANUARY 3, 2024

Wainua is the only FDA-approved drug for the treatment of ATTRv-PN that can be self-administered via an auto-injector. Approval of Wainua represents a meaningful advancement in treatment, one that gives those who are living with transthyretin-mediated amyloid polyneuropathy help managing the disease,” said Michael J.

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FDA Approval Protein RNA Clinical Trials 105

Pharmaceutical Technology

JUNE 21, 2023

With today’s FDA approval of Talzenna plus Xtandi, we are proud to be able to offer this potentially practice-changing treatment to patients and add to their options in managing this aggressive disease.” The regulatory approval was based on the findings obtained from the Phase III TALAPRO-2 trial.

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FDA Approval Gene DNA Medicine 130

Pharmaceutical Technology

MAY 25, 2023

Yuflyma represents the company’s fifth biosimilar and second anti-TNF biosimilar to receive US FDA approval. The regulatory approval was based on a comprehensive data package of preclinical, analytical and clinical trials. It will be offered to patients in prefilled syringe and autoinjector administration options.

FDA Approval 130

FDA Approval Packaging Packaging Clinical Trials 130

Pharmaceutical Technology

JUNE 6, 2023

American Regent chief medical officer Ravi Tayi stated: “This new indication for INJECTAFER marks the first and only FDA approval of an intravenous iron replacement therapy for adult patients with heart failure, a progressive and chronic disease. Approximately 2.8

FDA Approval 130

FDA Approval Trials Drugs 130

Pharmaceutical Technology

AUGUST 8, 2022

At week 24, both SPIRIT trials met the co-primary endpoints, with 75% of women receiving Myfembree having a clinically meaningful decline in dysmenorrhea versus 27% and 30% of women in the placebo arms, respectively. . The post US FDA approves Pfizer-Myovant’s Myfembree for endometriosis pain appeared first on Pharmaceutical Technology.

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FDA Approval Drugs Trials Marketing 189