Drug Discovery World

MAY 15, 2023

We are excited to support the acceleration of CytoAgents’ clinical development efforts and look forward to generating meaningful clinical data in patients.” CytoAgents anticipates the clinical trial to launch at its first trial site in the summer of 2023.

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials Trials 52

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 92

FDA Approval Drugs Clinical Development Development 92

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 83

FDA Approval Drugs Clinical Development Development 83

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 77

FDA Approval Branding Development Drugs 77

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 88

FDA Approval Branding Development Drugs 88

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 82

FDA Approval Clinical Development Development 82

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 94

FDA Approval Drugs Trials Development 94

The Pharma Data

JUNE 28, 2023

FDA Approves Pfizer’s NGENLA™, a Long-Acting Once-Weekly Treatment for Pediatric Growth Hormone Deficiency NEW YORK & MIAMI–(BUSINESS WIRE)– Pfizer Inc. NGENLA is approved for the treatment of pediatric GHD in more than 40 markets including Canada, Australia, Japan, and EU Member States.

Hormones 40

Hormones FDA Approval Clinical Development Medicine 40

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 81

FDA Approval Drugs Clinical Development Development 81

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 73

FDA Approval Drugs Trials Development 73

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

The Pharma Data

MAY 26, 2023

Pfizer’s PAXLOVID™ receives FDA approval for adult patients at high risk of progression to severe COVID-19 Pfizer Inc. NYSE: PFE) announced today that the U.S. ” COVID-19 continues to cause significant burden in the U.S. Source link: [link]

FDA Approval 40

FDA Approval HR Vaccination Vaccine 40

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

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

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

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

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 99

FDA Approval Clinical Trials Clinical Trials Trials 99

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

AUGUST 8, 2023

A new treatment option for adults with metastatic colorectal cancer (mCRC) could âchange the landscapeâ for those with the disease.

FDA Approval 52

FDA Approval Clinical Development Development 52

The Pharma Data

JUNE 7, 2023

FDA Approves New Indication for Merck’s PREVYMIS® (letermovir) for Prevention of Cytomegalovirus (CMV) Disease in High-Risk Adult Kidney Transplant Recipients Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Source link: [link]

FDA Approval 40

FDA Approval Drugs Clinical Development Medicine 40

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 86

FDA Approval Development Drugs Clinical Development 86

The Pharma Data

AUGUST 16, 2020

First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks. First and only approved therapy for NMOSD designed to target and inhibit interleukin-6 receptor activity, using novel recycling antibody technology.

FDA Approval 52

FDA Approval Antibody Clinical Trials Clinical Trials 52

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 79

FDA Approval Clinical Development Development 79

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

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 96

FDA Approval Production Trials Clinical Development 96

The Pharma Data

JANUARY 20, 2021

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction. This approval builds upon Merck’s proud history of developing therapies for the treatment of patients with cardiovascular disease.”. Related Articles: Verquvo (vericiguat) FDA Approval History. KENILWORTH, N.J.–(BUSINESS

FDA Approval 52

FDA Approval Production Trials Clinical Trials 52

The Pharma Data

NOVEMBER 20, 2020

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies. Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today announced that the U.S. PALO ALTO, Calif., Outside the U.S.,

FDA Approval 52

FDA Approval Genetics Clinical Trials Clinical Trials 52

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

Pharmaceutical Technology

AUGUST 5, 2022

The US Food and Drug Administration (FDA) approved Lynparza in March for this indication. A PARP inhibitor, Lynparza (olaparib) is said to be the first targeted therapy to hinder DNA damage response in cells/tumours with a deficiency in homologous recombination repair.

FDA Approval 147

FDA Approval DNA Clinical Trials Clinical Trials 147

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

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 116

Trials FDA Approval Clinical Development Development 116

BioTech 365

AUGUST 17, 2021

FDA Grants Accelerated Approval of JEMPERLI (dostarlimab-gxly) for dMMR Recurrent or Advanced Solid Tumors FDA Grants Accelerated Approval of JEMPERLI (dostarlimab-gxly) for dMMR Recurrent or Advanced Solid Tumors Second FDA Approval of PD-1 Antagonist Antibody Under Clinical Development for Solid Tumors in … Continue reading →

FDA Approval 40

FDA Approval Clinical Development Antibody Development 40

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

OCTOBER 21, 2020

and Shionogi Limited as shareholders, today announced the positive findings of a pooled analysis of COVID-19-related impacts across the investigational long-acting cabotegravir and rilpivirine clinical development programme. Related Articles: Cabenuva (cabotegravir and rilpivirine) FDA Approval History. Source: GSK .

Clinical Development 52

Clinical Development Development Medicine Clinical Trials 52

The Pharma Data

MAY 31, 2022

.” Evrysdi is approved in 81 countries and the dossier is under review in a further 27 countries. More than 5,000 patients have now been treated worldwide with Evrysdi in clinical trials, compassionate use or real-world settings.

FDA Approval 52

FDA Approval Protein In-Vitro Medicine 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 53

FDA Approval Trials Engineer Clinical Development 53