Pharmaceutical Technology

AUGUST 18, 2022

bluebird bio CEO Andrew Obenshain said: “The FDA approval of Zynteglo offers people with beta-thalassemia the possibility of freedom from burdensome regular red blood cell transfusions and iron chelation and unlocks new possibilities in their daily lives.

Gene Therapy 246

Gene Therapy Gene Genotype In-Vivo 246

BioPharma Reporter

AUGUST 13, 2024

The FDA has given the green light to Lymphir, the first immunotherapy for the treatment of cutaneous T-cell lymphoma (CTCL) to get approval in over five years.

FDA Approval 116

FDA Approval Clinical Development Development 116

Fierce Pharma

DECEMBER 13, 2024

Even though AI-designed drugs arent yet a household term for FDA-approved, commercially available therapies, they are a reality in clinical development pipelines.

FDA Approval 82

FDA Approval Clinical Development Drugs Development 82

BioSpace

NOVEMBER 2, 2021

Food and Drug Administration accepted Investigational New Drug Applications for multiple companies, clearing the way for clinical development. This week, the U.S.

FDA Approval 77

FDA Approval Drugs Clinical Development Development 77

XTalks

NOVEMBER 26, 2024

Patient advocacy groups, including the Amyloidosis Support Groups led by Muriel Finkel, highlight the transformative impact of Attruby on the lives of those with ATTR-CM.

Genetic Disease 105

Genetic Disease Genetics Protein Clinical Development 105

XTalks

DECEMBER 10, 2021

Zavegepant has an advantage over the two as it’s the only CGRP receptor antagonist in both intranasal spray and oral pill formulations that is in clinical development for the treatment of acute or episodic migraines.

FDA Approval 98

FDA Approval Trials Drugs Sales 98

BioPharma Reporter

AUGUST 2, 2021

The drug, intended for adult patients with moderate-to-severe systemic lupus erythematosus, is the only new therapy approved for SLE in more than a decade.

FDA Approval 98

FDA Approval Drugs Clinical Development Development 98

Outsourcing Pharma

JANUARY 25, 2022

The agency has given the go-ahead on an IND application for a study evaluating Ananda Scientificâs Nantheia ATL5, a candidate for treating opioid use disorder.

FDA Approval 102

FDA Approval Clinical Trials Clinical Trials Trials 102

pharmaphorum

AUGUST 10, 2020

Roche is hoping to undercut hugely expensive rivals after the FDA approved its oral spinal muscular atrophy (SMA) drug Evrysdi (risdiplam). The FDA approved Evrysdi for the treatment of spinal muscular atrophy (SMA) in adults and children two months of age and older.

FDA Approval 59

FDA Approval Drugs Gene Therapy Protein 59

Outsourcing Pharma

NOVEMBER 13, 2023

A small molecule, oral targeted therapy for adults with metastatic colorectal cancer (CRC) has been approved by the US Food and Drug Administration (FDA).

FDA Approval 88

FDA Approval Drugs Clinical Development Development 88

Outsourcing Pharma

SEPTEMBER 30, 2020

The companyâs Phase II trial of ultramicronized PEA has received FDA approval and expects to begin dosing patientparticipants as early as next month.

Trials 119

Trials FDA Approval Clinical Development Development 119

Outsourcing Pharma

DECEMBER 18, 2023

The oral treatment belzutifan, developed by MSD (known as Merck in the US) and branded as Welireg, has received the green light from the US Food and Drug Administration (FDA) for the treatment of an advanced form of renal cell carcinoma (RCC).

FDA Approval 92

FDA Approval Branding Development Drugs 92

Outsourcing Pharma

JULY 19, 2024

Phathom Pharmaceuticals, Inc.dedicated to developing and commercializing treatments for gastrointestinal (GI) diseases, announced today that the US Food and Drug Administration (FDA) has approved Voquenza (vonoprazan) 10mg tablets for the relief of heartburn associated with non-erosive gastroesophageal reflux disease (non-erosive GERD) in adults.

FDA Approval 88

FDA Approval Development Drugs Clinical Development 88

Outsourcing Pharma

DECEMBER 14, 2023

Mission Therapeutics, a clinical-stage biotech developing first-in-class therapeutics targeting mitophagy, has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) to proceed with a phase 2 trial for its kidney treatment MTX652.

FDA Approval 96

FDA Approval Drugs Trials Development 96

pharmaphorum

OCTOBER 5, 2020

The FDA has approved Opdivo (nivolumab) and Yervoy (ipilimumab), as the first and only immunotherapy for previously untreated unresectable malignant pleural mesothelioma. The post FDA approves BMS’ Opdivo and Yervoy combination in first-line mesothelioma appeared first on.

FDA Approval 59

FDA Approval Trials Clinical Development Development 59

Outsourcing Pharma

DECEMBER 19, 2023

The US Food and Drug Administration (FDA) has approved a topical foam developed by Arcutis Biotherapeutics and branded as Zoryve for the skin condition seborrheic dermatitis in people aged nine years and up.

FDA Approval 81

FDA Approval Branding Development Drugs 81

Delveinsight

SEPTEMBER 9, 2021

For each component, Adaptimmune has agreed to supervise clinical candidates development by using its induced pluripotent stem cell (iPSC) derived allogeneic platform for production of T-cells (iT cells). TransMedics receives FDA approval for its OCS heart system. Owlstone Medical raises USD 58 Million in Series D round.

FDA Approval 73

FDA Approval Development Research Production 73

Pharmaceutical Technology

JUNE 7, 2023

In 2017, the therapy received FDA approval for prophylaxis of CMV infection and disease in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant. The drug is given once a day as an oral tablet or as an injection for intravenous infusion.

FDA Approval 130

FDA Approval Clinical Development Drugs Medicine 130

Outsourcing Pharma

FEBRUARY 19, 2024

Patients in the US with epidermal growth factor receptor mutated (EGFRm) advanced lung cancer can now receive an important new treatment option delaying disease progression by nearly nine additional months.

FDA Approval 86

FDA Approval Clinical Development Development 86

Outsourcing Pharma

NOVEMBER 16, 2023

The first and only enzyme replacement therapy for the treatment of a very rare and complex blood disorder has been approved by the US Food and Drug Administration.

FDA Approval 85

FDA Approval Drugs Clinical Development Development 85

Pharmaceutical Technology

FEBRUARY 8, 2023

In 2020, the FDA released a guidance document for the industry with recommendations for sponsors developing gene therapies for rare diseases. This document delved into aspects related to manufacturing, preclinical, and clinical trial design for all phases of clinical development.

Gene Therapy 264

Gene Therapy Gene Trials Clinical Trials 264

Pharmaceutical Technology

MARCH 30, 2023

It is expected that medical societies, clinical researchers, government organisations, and particularly people living with lupus, the FDA stresses, will all contribute to address hurdles hampering the treatment landscape. Lupus is a difficult to treat – it has a range of symptoms and is poorly understood.

Development 162

Development Drugs FDA Approval Clinical Development 162

Outsourcing Pharma

JUNE 22, 2022

The company reports it has met the enrollment target for a trial of its sonic beam therapy, one step closer to submitting for FDA approval of the product.

FDA Approval 98

FDA Approval Production Trials Clinical Development 98

Outsourcing Pharma

DECEMBER 14, 2023

Mission Therapeutics, a clinical-stage biotech developing first-in-class therapeutics targeting mitophagy, has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) to proceed with a phase 2 trial for its kidney treatment MTX652.

FDA Approval 78

FDA Approval Drugs Trials Development 78

Outsourcing Pharma

SEPTEMBER 18, 2023

The small molecule drug Ojjaara (momelotinib), developed by GlaxoSmithKline, has become the first U.S. Food and Drug Administration (FDA)-approved treatment for patients with the blood cancer myelofibrosis and anemia.

FDA Approval 91

FDA Approval Development Drugs Clinical Development 91

pharmaphorum

SEPTEMBER 3, 2020

In a filing with the US financial regulator Compass laid out its plans to develop the drug known as COMP360, which is a crystalline formulation of psilocybin in phase 2b clinical development in patients who have not responded to standard therapy for depression.

Drugs 116

Drugs Life Science Clinical Development Regulation 116

pharmaphorum

MARCH 23, 2022

Merck & Co’s chief medical officer and head of clinical development Dr Roy Baynes has announced his retirement from the company to take up a new role alongside his former colleague Roger Perlmutter at biotech Eikon Therapeutics. billion last year.

Clinical Development 98

Clinical Development FDA Approval Vaccination Vaccine 98

The Pharma Data

AUGUST 31, 2021

10), as determined by an FDA-approved test, or in patients who were not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication was approved under accelerated approval based on tumor response rate and duration of response.

FDA Approval 52

FDA Approval Containment Clinical Development Trials 52

pharmaphorum

SEPTEMBER 21, 2020

COMP360 is a crystalline formulation of psilocybin in phase 2b clinical development in patients who have not responded to standard therapy for depression. UK-based Compass has a patented synthetic version of psilocybin, the active ingredient in magic mushrooms, and raised around $127.5

Medicine 134

Medicine FDA Approval Clinical Trials Clinical Trials 134

Outsourcing Pharma

JULY 7, 2023

It has the highest mortality rate of any psychiatric disorder, yet there is currently no FDA approved therapy for the condition. Anorexia nervosa is a notoriously difficult illness to treat.

FDA Approval 84

FDA Approval Clinical Development Development 84

The Pharma Data

NOVEMBER 30, 2020

NVX-CoV2373 (SARS-CoV-2 vaccine) FDA Approval History. Investors, potential investors, and others should give careful consideration to these risks and uncertainties. Source: Novavax, Inc. . Posted: November 2020. Source link.

Clinical Development 52

Clinical Development Vaccination Vaccine Development 52

The Pharma Data

AUGUST 24, 2020

In a paper published in Molecular Therapy: Methods & Clinical Development , the team discussed why they choose this type of gene therapy to treat HIV. They said: “Recent studies in HIV controllers highlighted the importance for HIV-specific CD4 T cells in controlling HIV replication and disease progression.

Gene Therapy 52

Gene Therapy Gene FDA Approval Trials 52

The Pharma Data

NOVEMBER 24, 2020

FDA Approves Oxlumo (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1. Food and Drug Administration (FDA) approved Oxlumo (lumasiran) injection for subcutaneous use, the first-ever therapy available for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients.

FDA Approval 52

FDA Approval Production RNA Medicine 52

Pharmaceutical Technology

MARCH 1, 2023

While the pandemic dramatically increased public awareness of mRNA therapeutics, lesser-known categories of RNA-based therapies have been established and approved for use by the FDA for almost a decade. These include antisense oligonucleotides (ASO), RNA interference (RNAi), and RNA aptamers.

RNA 147

RNA Vaccination Vaccine Genetics 147

BioPharma Reporter

OCTOBER 22, 2024

The FDA has simultaneously granted approval to Astellasâ cancer drug Vyloy and to a companion diagnostic test developed by Roche.

FDA Approval 52

FDA Approval Development Drugs Clinical Development 52

The Pharma Data

OCTOBER 31, 2020

Taigexyn ® is already on the market in the mainland China and Taiwan , TG-3000 has completed Phase 2 clinical studies, and Furaprevir is currently in Phase 3 clinical development. View original content: [link]. SOURCE TaiGen. Source link.

FDA Approval 52

FDA Approval Marketing Clinical Development Development 52

Outsourcing Pharma

NOVEMBER 19, 2020

The control arm, engineered from historical trial data derived from more than 22,000 previous studies, will be used in a Phase III cancer trial.

FDA Approval 54

FDA Approval Trials Engineer Clinical Development 54