XTalks

JUNE 17, 2024

Initially, these lines might only be noticeable during specific facial expressions in youth, but over time, the surrounding tissue may develop persistent wrinkles. Developed by Revance Therapeutics, Daxxify stands out for its composition, which is devoid of both human serum albumin and animal-based components.

FDA Approval 52

FDA Approval Marketing Botox Clinical Trials 52

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.

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FDA Approval Development Drugs Clinical Development 85

pharmaphorum

MAY 16, 2022

The findings were made via Lilly’s SURPASS phase 3 global clinical development programme, which comprised studies ranging from 40 to 52 weeks. These examined Mounjaro in 5mg, 10mg and 15 mg doses in five clinical trials, used either as a stand-alone therapy or as an add-on to other diabetes medicines.

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FDA Approval Insulin Drugs Hormones 113

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.

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FDA Approval Drugs Clinical Development Development 78

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.

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FDA Approval Clinical Development Development 116

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.

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FDA Approval Development Drugs Clinical Development 52

XTalks

NOVEMBER 15, 2023

XTALKS WEBINAR: Vaccine Clinical Development: Key Ingredients to Improve Efficiency Live and On-Demand: Monday, November 20, 2023, at 10am EST (4pm CET/EU-Central) Register for this free webinar to learn ways to improve the efficiency of vaccine development. The data showed a 98.9

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FDA Approval Vaccination Vaccine In-Vitro 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 78

FDA Approval Branding Development Drugs 78

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).

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FDA Approval Branding Development Drugs 90

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.

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FDA Approval Drugs Trials Development 95

Pharmaceutical Technology

SEPTEMBER 23, 2022

While a handful of therapies have launched since then, late-stage pipeline therapies that are currently in development reveal that drug developers are exploring a broad set of mechanisms of action (MOAs), many of which are innovative, to tackle DES.

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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 Voquezna (vonoprazan) 10mg tablets for the relief of heartburn associated with non-erosive gastroesophageal reflux disease (non-erosive GERD) in adults.

FDA Approval 52

FDA Approval Development Drugs Clinical Development 52

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.

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FDA Approval Drugs Trials Development 75

Pharmaceutical Technology

NOVEMBER 30, 2022

This is the first approval for Biktarvy in paediatric indication in the EU and applies to all 27 EU member states, Liechtenstein, Norway and Iceland. The latest development is based on data obtained from an open-label clinical trial of Biktarvy.

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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 85

FDA Approval Drugs Clinical Development Development 85

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.

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FDA Approval Drugs Gene Therapy Protein 59

The Pharma Data

NOVEMBER 30, 2020

Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today provided an update on its COVID-19 vaccine program. is undertaking clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. GAITHERSBURG, Md., Source link.

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BioPharma Reporter

OCTOBER 24, 2024

The US pharma giant Pfizer recently announced that its respiratory syncytial virus (RSV) vaccine Abrysvo has received FDA approval in adults aged 18 to 59 who are at an increased risk of developing lower respiratory tract disease caused by RSV (RSV-LRTD).

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Vaccination Vaccine FDA Approval Development 52

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.

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FDA Approval Trials Clinical Development Development 59

Delveinsight

SEPTEMBER 9, 2021

A collaboration valued more than USD 3 billion, Genentech, a member of the Roche Group, declared it will collaborate with Adaptimmune for developing and commercializing allogeneic T-cell therapies to treat multiple cancer indications. TransMedics receives FDA approval for its OCS heart system.

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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.

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FDA Approval Development Drugs Clinical Development 88

pharmaphorum

MAY 30, 2022

Despite this, the first-ever FDA-approved KRAS G12C inhibitor has demonstrated that RAS is in fact druggable and that drugging this protein unlocks a world of successful therapeutic interventions. Continuing to advance valuable combination therapies into the clinic, and finally, crack resistance to RAS targeted therapeutics.

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Development Drugs FDA Approval Clinical Trials 52

XTalks

SEPTEMBER 4, 2024

In this episode, Ayesha spoke with Jennifer Gudeman, Pharm D, Senior Vice President, Medical and Clinical Affairs, Avadel Pharmaceuticals , a biopharmaceutical company working on innovative solutions to the development of medications that disrupt treatment paradigms and address unmet needs. Dr. Gudeman joined Avadel in 2020.

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Life Science Clinical Development FDA Approval Regulation 52

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 84

FDA Approval Clinical Development Development 84

XTalks

NOVEMBER 5, 2024

Proceeds from the IPO will fund preclinical and clinical development for Polyrizon’s innovative hydrogel product candidates, supporting further research and development (R&D). Trading began on the Nasdaq Capital Market under the ticker “PLRZ” on October 29, 2024.

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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.

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FDA Approval Trials Drugs Sales 92

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.

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FDA Approval Drugs Clinical Development Development 83

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]

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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.

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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.

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FDA Approval Drugs Clinical Development Development 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 Clinical Research 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.

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FDA Approval Clinical Trials Clinical Trials Trials 101

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.

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Outsourcing Pharma

JUNE 27, 2024

The US Food and Drug Administration (FDA) has approved Verona Pharmaâs Ohtuvayre (ensifentrine), marking a significant milestone in the treatment of chronic obstructive pulmonary disease (COPD).

FDA Approval 52

FDA Approval Sales Drugs Clinical Development 52

XTalks

JULY 25, 2024

Life Biosciences is developing a gene therapy for primary open-angle glaucoma (POAG) and non-arteritic anterior ischemic optic neuropathy (NAION), two types of optic neuropathies with significant unmet needs. Jerry began his career at Merck and was extensively involved in multiple blockbuster product launches.

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Life Science Gene Therapy FDA Approval Clinical Development 59

XTalks

NOVEMBER 7, 2024

XTALKS WEBINAR: Utilizing the Measurement of Cognition to Determine Drug Safety in Late Phase Clinical Trials Live and On-Demand: Wednesday, November 20, 2024 , at 11am EST (4pm GMT / UK) Register for this free webinar to learn how cognitive assessment plays a critical role in demonstrating central nervous system (CNS) safety in drug development.

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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.

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Gene Therapy Gene FDA Approval Trials 52