Pharmaceutical Technology

MARCH 10, 2023

The US Food and Drug Administration (FDA) has granted approval for Pfizer ’s Zavzpret (zavegepant) for the acute treatment of migraine in adult patients with or without aura. Zavzpret is claimed to be the first and only calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray approved to treat migraine.

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FDA Approval Pharmacy Trials Clinical Development 246

Pharmaceutical Technology

JUNE 9, 2023

Biopharmaceutical company Novaliq has received approval from the US Food and Drug Administration (FDA) for VEVYE (cyclosporine ophthalmic solution) 0.1% It has been designed to address the unmet needs of patients and to provide quick action and well-tolerated dry eye drug therapy.

FDA Approval 246

FDA Approval Bioavailability Containment Drugs 246

Bio Pharma Dive

APRIL 27, 2023

Trial participants lost up to 15% of their body weight in a finding that should help the closely watched GLP-1 drug gain an FDA approval for obesity.

FDA Approval 309

FDA Approval Drugs Trials 309

AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 12, 2023

The US Food and Drug Administration (FDA) on Wednesday announced it had approved Eli Lilly’s highly anticipated weight loss drug Zepbound, the latest entrant in a field of powerful – and lucrative – new obesity medicines.​

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FDA Approval Drugs Medicine Clinical Trials 188

Pharmaceutical Technology

AUGUST 12, 2022

The US Food and Drug Administration (FDA) has granted approval for Daiichi Sankyo and AstraZeneca ’s Enhertu (fam-trastuzumab deruxtecan-nxki) to treat unresectable or metastatic non-small cell lung cancer (NSCLC) in adults. In the trial, 1.9% In the trial, 1.9%

FDA Approval 264

FDA Approval Clinical Trials Clinical Trials Engineer 264

Pharmaceutical Technology

JANUARY 9, 2023

Eisai and Biogen have received approval for their antibody Leqembi (lecanemab-irmb) , 100mg/mL injection for intravenous use, from the US Food and Drug Administration (FDA) under the Accelerated Approval Pathway to treat Alzheimer’s disease (AD).

FDA Approval 246

FDA Approval Antibody Clinical Trials Clinical Trials 246

Pharmaceutical Technology

APRIL 27, 2023

Seres Therapeutics and Nestlé Health Science have received approval from the US Food and Drug Administration (FDA) for Vowst (faecal microbiota spores, live-brpk) for preventing the recurrence of C difficile infection (CDI) in adults. It is not indicated to treat CDI.

FDA Approval 246

FDA Approval Regulation Trials Development 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

MARCH 13, 2023

The US Food and Drug Administration (FDA) has granted approval for Acadia Pharmaceuticals ’ Daybue (trofinetide) to treat Rett syndrome in adult and paediatric patients aged two years and above. It increased the branching of dendrites and synaptic plasticity signals in animal trials.

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FDA Approval Trials Drugs 182

Pharmaceutical Technology

FEBRUARY 2, 2023

The US Food and Drug Administration (FDA) has approved GlaxoSmithKline ’s (GSK) Jesduvroq (daprodustat) to treat anaemia caused by chronic kidney disease (CKD) in adults who have been on dialysis for at least four months. Jesduvroq is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI). dL) for the patients.

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FDA Approval Life Science Genetics Trials 264

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 150

Pharmaceutical Technology

FEBRUARY 20, 2023

The US Food and Drug Administration (FDA) has granted approval for Apellis Pharmaceuticals’ Syfovre (pegcetacoplan injection) to treat geographic atrophy (GA), an advanced form of age-related macular degeneration (AMD). Syfovre reduced the GA lesion growth rate compared to sham injections in both the OAKS and DERBY studies.

FDA Approval 246

FDA Approval Trials Drugs 246

Bio Pharma Dive

AUGUST 2, 2021

The regulator cleared Saphnelo despite mixed clinical trial data, giving patients another option after the recent OK for a drug aimed at the autoimmune disease's severe side effects.

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FDA Approval Clinical Trials Clinical Trials Drugs 340

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.

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FDA Approval Trials Drugs 76

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). Furthermore, the company intends to commercialise the drug in the country within a few weeks.

FDA Approval 147

FDA Approval Trials Drugs Development 147

XTalks

APRIL 3, 2024

The US Food and Drug Administration (FDA) has given the nod to AstraZeneca’s Voydeya (danicopan) as an add-on therapy to the company’s standard-of-care C5 inhibitors Ultomiris (ravulizumab) or Soliris (eculizumab) for the treatment of extravascular hemolysis (EVH) in adults with the rare blood disease paroxysmal nocturnal hemoglobinuria (PNH).

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FDA Approval Sales Trials Development 102

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). Nausea, headache, and nasopharyngitis are the most common adverse events observed in patients treated with Cibinqo in the trials.

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FDA Approval Trials Clinical Trials Clinical Trials 147

Pharmaceutical Technology

AUGUST 8, 2022

AstraZeneca and Daiichi Sankyo ’s Enhertu (trastuzumab deruxtecan) has received expanded approval from the US Food and Drug Administration (FDA) to treat adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer. Enhertu-treated subjects had a median overall survival (OS) of 23.4

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FDA Approval HR Clinical Trials Clinical Trials 264

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).

FDA Approval 130

FDA Approval Genetics Trials Medicine 130

Pharmaceutical Technology

MAY 11, 2023

Otsuka Pharmaceutical and H Lundbeck have received approval for the supplemental new drug application (sNDA) from the US Food and Drug Administration for Rexulti (brexpiprazole) to treat agitation associated with dementia due to Alzheimer’s disease.

FDA Approval 147

FDA Approval Trials Regulation Drugs 147

Pharmaceutical Technology

FEBRUARY 9, 2023

The US Food and Drug Administration (FDA) has granted approval for Regeneron Pharmaceuticals’ Eylea (aflibercept) injection to treat the retinopathy of prematurity (ROP) in preterm infants. The post US FDA approves Regeneron’s Eylea for retinopathy of prematurity in infants appeared first on Pharmaceutical Technology.

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FDA Approval Trials Development Drugs 130

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

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.

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FDA Approval Genetics Gene Therapy Gene 105

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.

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FDA Approval Bacteria Trials Protein 95

Pharmaceutical Technology

MARCH 27, 2023

The US Food and Drug Administration (FDA) has granted approval for Pharming Group’s Joenja (leniolisib) to treat adult and paediatric patients aged 12 years and above with activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS). Joenja is an oral, selective small molecule PI3Kẟ inhibitor.

FDA Approval 130

FDA Approval Clinical Trials Clinical Trials Medicine 130

Pharmaceutical Technology

JANUARY 12, 2023

The US Food and Drug Administration (FDA) has approved AstraZeneca and Avillion’s Airsupra (albuterol/budesonide), to treat asthma. Airsupra has been approved for the as-needed treatment or prevention of bronchoconstriction and for reducing the exacerbations risk in asthma patients aged 18 years and above.

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FDA Approval Trials Development Drugs 130

Pharmaceutical Technology

MAY 23, 2023

The US Food and Drug Administration (FDA) has granted approval for Indivior’s Opvee (nalmefene) nasal spray to reverse opioid overdose. The regulatory approval was based on the findings obtained from a pharmacodynamic study, which was conducted on 61 opioid-experienced, non-dependent participants. and five minutes.

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FDA Approval Trials Marketing Development 130

XTalks

JANUARY 2, 2024

Chiesi Global Rare Diseases, a specialized division within the Chiesi Group dedicated to pioneering therapies for individuals affected by rare diseases, has received approval from the US Food and Drug Administration (FDA) for Filsuvez (birch triterpenes) topical gel. Specifically, 41.3 percent observed in the control gel arm.

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FDA Approval Gene Therapy Gene Trials 111

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). Trials peaked at 115 in 2018 before declining to 91 last year.

FDA Approval 244

FDA Approval Hormones Trials Clinical Trials 244

Pharmaceutical Technology

FEBRUARY 24, 2023

Sanofi has received approval from the US Food and Drug Administration (FDA) for its Altuviiio [Antihemophilic Factor (Recombinant) , Fc-VWF-XTEN Fusion Protein-ehtl], to treat a type of inherited bleeding disorder known as haemophilia A. Earlier, they received treatment with factor VIII replacement therapy. median ABR.

FDA Approval 147

FDA Approval Protein Trials Drugs 147

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.

FDA Approval 105

FDA Approval Protein RNA Clinical Trials 105

XTalks

JUNE 26, 2023

has announced that its new drug-coated balloon (DCB) SurVeil has been granted approval by the US Food and Drug Administration (FDA). The approval comes after the FDA made several requests for additional data, which lengthened the approval process that began in 2021.

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FDA Approval Drugs Sales In-Vitro 96

Pharmaceutical Technology

AUGUST 8, 2022

The US Food and Drug Administration (FDA) has granted approval for Pfizer and Myovant Sciences ’ Myfembree (relugolix 40mg, estradiol 1mg and norethindrone acetate 0.5mg) to manage moderate-to-severe pain linked with endometriosis in pre-menopausal women.

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FDA Approval Drugs Trials Marketing 189

Pharmaceutical Technology

SEPTEMBER 5, 2022

The US Food and Drug Administration (FDA) has approved the expanded usage of Vertex Pharmaceuticals ’ Orkambi (lumacaftor/ivacaftor) to treat cystic fibrosis (CF) in children aged 12 months to under 24 months. It enrolled 46 children aged one to under two years with the F/F genotype.

FDA Approval 130

FDA Approval Genotype Clinical Trials Clinical Trials 130

XTalks

APRIL 5, 2024

Amylyx Pharmaceuticals announced yesterday that it will be pulling its ALS (amyotrophic lateral sclerosis) drug Relyvrio from the market after failing in a confirmatory trial. Last month, Amylyx reported results from the global PHOENIX Phase III clinical trial that were unable to confirm the drug’s effectiveness.

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Trials Drugs Marketing FDA Approval 98

Pharmaceutical Technology

JUNE 19, 2023

UK-based pharmaceutical giant GSK has announced that the US Food and Drug Administration (FDA) has extended the review period of its new drug application (NDA) for the rare bone cancer drug momelotinib by three months. The FDA’s review will take into account data from the Phase III MOMENTUM trial (NCT04173494).

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Drugs FDA Approval Development Production 246

Pharmaceutical Technology

JUNE 21, 2023

The US Food and Drug Administration (FDA) has granted approval to Pfizer’s Talzenna (talazoparib) along with Xtandi (enzalutamide) for prostate cancer. 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