Pharmaceutical Technology

FEBRUARY 2, 2023

We are proud to have developed Jesduvroq as a new oral treatment where there is a patient desire for more options.” 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.

FDA Approval 264

FDA Approval Life Science Genetics Trials 264

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% VEVYE, the development name of which is CyclASol, is a cyclosporine, solubilised solution in a new, water-free excipient. to treat the signs and symptoms of dry eye disease.

FDA Approval 246

FDA Approval Bioavailability Containment Drugs 246

XTalks

APRIL 3, 2024

Approximately ten to 20 percent of patients with PNH may develop extravascular hemolysis (EVH), a condition that causes RBC destruction outside of blood vessels. Voydeya is the first-in-class, oral, factor D inhibitor developed specifically as an add-on to ravulizumab or eculizumab for patients who develop EVH.

FDA Approval 102

FDA Approval Sales Trials Development 102

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

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. A VEGF inhibitor, Eylea is jointly developed by Bayer and Regeneron Pharmaceuticals.

FDA Approval 130

FDA Approval Trials Development Drugs 130

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

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

JANUARY 12, 2023

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. It is claimed to be the first and only rescue medication approved for this indication in the country.

FDA Approval 130

FDA Approval Trials Development Drugs 130

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

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

Pharmaceutical Technology

MAY 22, 2023

It is claimed to be both the first re-dosable gene therapy and the first and only FDA-approved treatment for both recessive and dominant types of DEB, a rare and serious genetic disease affecting the skin and mucosal tissues. The regulatory approval was supported by data from the GEM-1/2 and GEM-3 clinical trials.

FDA Approval 130

FDA Approval Gene Therapy Genetic Disease Gene 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.

FDA Approval 101

FDA Approval Trials Clinical Trials Clinical Trials 101

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

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

FDA Approval 105

FDA Approval Genetics Gene Therapy Gene 105

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. percent of cases. Vyjuvek is a gene therapy that employs a herpes simplex virus type 1 (HSV-1) vector.

FDA Approval 111

FDA Approval Gene Therapy Gene Trials 111

Pharmaceutical Technology

JUNE 21, 2023

It is claimed to be the first anti-inflammatory atheroprotective cardiovascular treatment to receive approval from the regulator. The regulatory approval was based on the findings obtained from a double-blind, multinational, placebo-controlled, randomised clinical trial conducted in 5,522 chronic coronary disease patients.

FDA Approval 246

FDA Approval Cardiology Clinical Trials Clinical Trials 246

XTalks

AUGUST 7, 2023

Ycanth (cantharidin) topical solution, developed by Verrica Pharmaceuticals Inc., has received US Food and Drug Administration (FDA) approval for treating molluscum contagiosum in adult and pediatric patients aged two years and older in the US. What is Molluscum Contagiosum?

FDA Approval 98

FDA Approval Dermatology Clinical Trials Clinical Trials 98

Pharmaceutical Technology

MAY 1, 2023

Teva Pharmaceuticals and MedinCell have received approval from the US Food and Drug Administration (FDA) for Uzedy (risperidone) extended-release injectable suspension to treat adult patients with schizophrenia, a chronic, progressive, and severely debilitating mental health disorder.

FDA Approval 189

FDA Approval Clinical Trials Clinical Trials Trials 189

Pharma Mirror

MARCH 10, 2021

A post-pandemic pharma report from CPhI predicts the next few years will deliver strong growth in pharma innovation, with oncology and rare diseases potentially the biggest beneficiaries of positive covid legacies – including accelerated development timelines, remote trials and new technologies in genetic and target screening.

FDA Approval 130

FDA Approval Genetics Trials Development 130

XTalks

APRIL 25, 2024

Now we recognize that over the last ten years or so there have been major developments in pharmacotherapy for the management of different etiologies of heart failure,” says Dr. Nicholas Alp, MD, PhD, FACC, FRCP, Vice President of the Medical Department at Medpace. Survival rates were also impressive, exceeding 90 percent at one year.

Development 111

Development Trials Clinical Trials Clinical Trials 111

XTalks

FEBRUARY 6, 2023

GlaxoSmithKline LLC (GSK) recently announced that the US Food and Drug Administration (FDA) approved Jesduvroq (daprodustat), a new once-a-day oral treatment for anemia due to chronic kidney disease (CKD). The approval is currently only for adult patients who have been undergoing dialysis for at least four months.

FDA Approval 97

FDA Approval Clinical Trials Clinical Trials Trials 97

Drug Discovery World

APRIL 10, 2024

iECURE has been given the go-ahead to begin US trials of its investigational gene editing-based therapy in newborn males with neonatal onset Ornithine Transcarbamylase (OTC) deficiency. The post FDA approves first in vivo gene insertion programme in infants appeared first on Drug Discovery World (DDW).

In-Vivo 80

In-Vivo FDA Approval Gene Gene Editing 80

Pharmaceutical Technology

APRIL 18, 2023

The regulatory approval for the expanded indication was based on the data obtained from the pivotal Phase III PROGRESS trial, which assessed the efficacy, tolerability and safety of oral Qulipta 60mg once daily (QD) in adult patients with chronic migraine. The 60mg dose is indicated for chronic migraine patients.

FDA Approval 130

FDA Approval Botox Gene Trials 130

Pharmaceutical Technology

JUNE 13, 2023

The US Food and Drug Administration (FDA) has granted approval for Ironwood Pharmaceuticals’ LINZESS (linaclotide) as a once-a-day treatment for functional constipation in paediatric patients aged between six and 17 years.

FDA Approval 130

FDA Approval Trials Marketing Development 130

Pharmaceutical Technology

JUNE 13, 2023

Neobiosis chief scientific officer and CEO Dr Ian White stated: “This is an important milestone for Neobiosis and we are excited to be advancing ViXome, a refined product extracted from thoroughly screened and sterile amniotic fluid obtained at the time of C-section [Caesarean delivery] of full-term pregnancies, into clinical development. “We

FDA Approval 147

FDA Approval Production Clinical Development Manufacturing 147

XTalks

APRIL 24, 2024

ImmunityBio’s Anktiva (N-803, or nogapendekin alfa inbakicept-pmln) along with the Bacillus Calmette-Guérin (BCG) vaccine has won US Food and Drug Administration (FDA) approval for the treatment of non-muscle invasive bladder cancer (NMIBC). months in the KEYNOTE-057 trial.

FDA Approval 52

FDA Approval Vaccination Vaccine Sales 52

pharmaphorum

OCTOBER 4, 2022

The approval brings hope to many, with breast cancer having surpassed lung cancer to become the most commonly diagnosed cancer in the world: there are approximately 2.3 ENHERTU was jointly developed and commercialised by AstraZeneca and Daiichi Sankyo, based on the results of the phase 3 DESTINY-Breast04 trial.

FDA Approval 105

FDA Approval Protein Antibody Engineer 105

XTalks

JULY 25, 2023

“The approval of Cyfendus vaccine is symbolic of Emergent’s longstanding partnership with the US government and our shared commitment to helping protect public health,” said Dr. Kelly Warfield, Emergent’s senior vice president, science and development, in the company’s press release. What Is Anthrax? How Does Cyfendus Work?

FDA Approval 98

FDA Approval Vaccination Vaccine Antibody 98

Worldwide Clinical Trials

FEBRUARY 26, 2024

With the necessary prioritization of various factors when designing your clinical trial, the patient experience can be overlooked or improperly addressed in study design. However, incorporating the patient experience into your design is one of the best ways to ensure your drug development program is a commercial success.

Clinical Trials 137

Clinical Trials Clinical Trials Trials Clinical Research 137

Drug Discovery World

DECEMBER 20, 2023

The approval is based on clinical data which found that Padcev plus pembrolizumab nearly doubled median overall survival compared to standard of care platinum-based chemotherapy. In the Phase III EV-302 trial, median overall survival (OS) was 31.5 ” Enfortumab vedotin-ejfv was co-developed by Pfizer and Astellas.

FDA Approval 52

FDA Approval Antibody Trials Drugs 52

XTalks

MARCH 9, 2023

The disease develops between the ages of 20 to 30 and progresses over time, often leading to end-stage kidney failure due to glomerular disease. Results for this endpoint are expected in the final quarter of 2023 and are expected to support the traditional approval of Filspari.

FDA Approval 98

FDA Approval Drugs Clinical Trials Clinical Trials 98

XTalks

DECEMBER 14, 2023

Evive Biotech, a leading biopharmaceutical company based in China, and Acrotech Biopharma, a subsidiary of Aurobindo Pharma USA in New Jersey, have jointly announced a major achievement with the US Food and Drug Administration’s (FDA) approval of Ryzneuta (efbemalenograstim alfa) for treating chemotherapy-induced neutropenia (CIN).

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials Trials 52

XTalks

JUNE 26, 2023

Obtaining FDA approval for our SurVeil DCB is one of the most important achievements in Surmodics’ history,” said Gary Maharaj, president and CEO of Surmodics, in the company’s press release. “It SurVeil has an edge over IN.PACT as it is coated with a lower dose of the drug.

FDA Approval 96

FDA Approval Drugs Sales In-Vitro 96

XTalks

OCTOBER 25, 2022

The FDA clearance is the first for tremelimumab, which faced an uphill battle after having suffered several failures in trials for other cancer types over the past two decades of its development, including non-small cell lung cancer, head and neck cancer and bladder cancer.

FDA Approval 98

FDA Approval Trials Immune Response Drugs 98

Pharmaceutical Technology

APRIL 20, 2023

It is claimed to be the first therapy in 20 years to receive approval in the US as a first-line treatment for DLBCL. Roche chief medical officer and global product development head Levi Garraway stated: “It has been nearly 20 years since a new treatment option has become available to people newly diagnosed with diffuse large B-cell lymphoma.

FDA Approval 130

FDA Approval Trials Production Development 130

XTalks

JANUARY 4, 2023

MediWound, a biopharmaceutical company focused on biotherapeutic solutions for tissue repair and regeneration, announced that the US Food and Drug Administration (FDA) approved their orphan biological product NexoBrid (anacaulase-bcdb) for the removal of eschar in adults with deep partial-thickness and/or full-thickness thermal burns.

FDA Approval 98

FDA Approval Clinical Trials Clinical Trials Contamination 98

The Pharma Data

JUNE 2, 2023

Food and Drug Administration (FDA) for the treatment of adult patients with deleterious or suspected deleterious BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC). Patients should be selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

FDA Approval 52

FDA Approval HR Trials Hormones 52