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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pharmaphorum

DECEMBER 19, 2022

Dr Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said: “This approval provides healthcare professionals with an innovative treatment option for [these] patients.”. The post FDA approves Adstiladrin as first gene therapy for NMIBC appeared first on.

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Gene Therapy FDA Approval Gene Drugs 118

Bio Pharma Dive

SEPTEMBER 1, 2022

Approval of Xenpozyme, a treatment for a form of Niemann-Pick disease, comes with a valuable priority review voucher for Sanofi.

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Drug Discovery World

FEBRUARY 19, 2024

“Unresectable or metastatic melanoma is an aggressive form of cancer that can be fatal,” said Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research (CBER). Amtagvi is the first FDA-approved tumour-derived T cell immunotherapy.

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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.

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Pharmaceutical Technology

JUNE 1, 2023

According to figures from GlobalData’s clinical trials database, research into mCRPC treatments has been on the rise over the past 10 years. The five-year survival rates for mCRPC patients is poor, and paired with a worse prognosis for the 10% of patients with BRCAm, new treatments are necessary in this space.

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Bio Pharma Dive

SEPTEMBER 26, 2023

Once valued at more than $7 billion, the liver drug company couldn’t secure a long-sought FDA approval in NASH and last month said it would abandon that research.

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Drug Discovery World

AUGUST 11, 2023

The new complement C5 inhibitor is the only approved GA treatment with a statistically significant reduction in the rate of GA progression at the 12-month primary endpoint across two Phase III clinical trials. The FDA approval of Izervay is great news for the retina community and our patients suffering from GA.”

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Bio Pharma Dive

JUNE 16, 2023

The approval of Columvi adds another “bispecific antibody” to the market, highlighting the fast research progress for drugs that target two proteins rather than one.

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XTalks

FEBRUARY 15, 2023

Polarean is a medical imaging company focused on improving the state of lung imaging that recently received FDA approval for its drug-device combination product, Xenoview. Tune into the episode to learn more about the FDA approval of Xenoview, including the journey to its approval.

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Drug Discovery World

MARCH 22, 2024

.” Martine Clozel, MD and Chief Scientific Officer of Idorsia, concluded: “After more than 30 years working in the field of endothelin science, our research has brought about changes in the treatment paradigm of several cardiovascular diseases.

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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.

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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. In the U.S., For the U.S.

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FDA Approval HR Trials Hormones 52

Pharmaceutical Technology

APRIL 11, 2023

Zydus has manufacturing sites and research facilities across five Indian states, including Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim. The vaccine, which generates the SARS-CoV-2 viral spike protein on administration, induces the immune system’s cellular and humoral arm-mediated immune response.

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FDA Approval Drugs Immune Response Manufacturing 130

Pharmaceutical Technology

JUNE 13, 2023

The company’s products are processed in advanced FDA-inspected, FDA-registered, cGMP (current good manufacturing process)-compliant cleanrooms in Gainesville, Florida, US. Its research and development activities are performed at the University of Florida’s Sid Martin Innovate Biotechnology Institute in Alachua, Florida.

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Outsourcing Pharma

MARCH 31, 2022

A renowned university researcher explains the path that laid the foundation and what the novel diagnostic and treatment means for prostate cancer patients.

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XTalks

SEPTEMBER 14, 2022

Daxxify was FDA-approved for similar cosmetic purposes as Botox and other neuromodulators like Dysport and Xeomin. Used for both cosmetic and therapeutic cases, Botox is a US Food and Drug Administration (FDA)-approved injection of botulinum toxin, a neurotoxic protein that can effectively paralyze the facial muscles.

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Botox FDA Approval Cosmetics Clinical Trials 98

Bio Pharma Dive

OCTOBER 14, 2020

Research for the drug, now cleared as Inmazeb, helped Regeneron jumpstart its fast development of an antibody therapy for COVID-19.

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Antibody FDA Approval Drugs Development 248

XTalks

JANUARY 13, 2023

FDA approval represents achievement of a major milestone for Polarean’s technology. This was only possible in close collaboration with multiple research clinicians and scientists globally, who we thank for their tireless and enthusiastic work,” said Richard Hullihen, Chief Executive Officer of Polarean in the company’s press release.

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XTalks

APRIL 7, 2022

Abbott Laboratories announced on Monday that the US Food and Drug Administration (FDA) approved its Aveir™ single-chamber (VR) leadless pacemaker system. The Illinois-based company received the FDA nod for its new pacemaker to treat patients with bradycardia (slow heart rhythms).

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XTalks

OCTOBER 4, 2022

More than 70 research publications and presented abstracts on clinical data show the potential of Terlivaz for treating HRS. The life expectancy of HRS-affected patients is very low, and the only definitive treatment is liver transplantation. Terlivaz — A Treatment for the Dreaded HRS. Terlivaz is a vasopressin receptor agonist.

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Drug Discovery World

JUNE 6, 2023

Today’s approval is a monumental step forward in delivering on Pfizer’s commitment to help alleviate the significant burden of RSV in higher-risk populations, which includes older adults,” said Annaliesa Anderson, Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer.

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FDA Approval Vaccination Vaccine Clinical Trials 52

pharmaphorum

AUGUST 21, 2020

It’s mission accomplished for Novartis after the FDA approved ofatumumab for multiple sclerosis, completing a project where the former cancer drug has been repurposed. The FDA approved ofatumumab under the brand name Kesimpta for people living with relapsing forms of multiple sclerosis.

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XTalks

JULY 28, 2021

Merck has scored US Food and Drug Administration (FDA) approval for its next-generation pneumonia vaccine Vaxneuvance that covers 15 different strains of the pneumococcal bacteria that causes the infection.

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FDA Approval Vaccination Vaccine Immune Response 89

XTalks

OCTOBER 22, 2021

In July 2021, the agency approved the first interchangeable biosimilar product, Semglee (insulin glargine-yfgn) for the treatment of diabetes. The FDA approved the supplemental Biologics License Application (sBLA) for Cyltezo as the first interchangeable biosimilar with Humira.

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XTalks

NOVEMBER 10, 2023

Today, we are proud to further support the rare disease community by delivering Adzynma as the first FDA-approved therapeutic option for people with cTTP.” In 2022, the FDA approved 20 orphan drugs out of the 37 novel drugs approved by the FDA’s Center for Drug Evaluation and Research (CDER).

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Medical Xpress

FEBRUARY 8, 2023

To date, there are no FDA-approved treatments specifically targeting this disorder. Notalgia paresthetica—a nerve disorder characterized by a persistent itch in the upper back—is a common and underdiagnosed condition worldwide.

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Drug Discovery World

AUGUST 23, 2023

Pfizer’s Abrysvo (Respiratory Syncytial Virus Vaccine) was approved for use at 32-36 weeks gestational age of pregnancy to prevent lower respiratory tract disease (LRTD) and severe LRTD caused by RSV in infants from birth to six months of age.

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Scienmag

FEBRUARY 25, 2022

Several FDA-approved drugs — including for type 2 diabetes, hepatitis C and HIV — significantly reduce the ability of the Delta variant of SARS-CoV-2 to replicate in human cells, according to new research led by scientists at Penn State. UNIVERSITY PARK, Pa.

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BioTech 365

JANUARY 26, 2022

Melanoma Research Alliance Statement on FDA Approval of Tebentafusp, the First Drug for Treating Metastatic Uveal Melanoma Melanoma Research Alliance Statement on FDA Approval of Tebentafusp, the First Drug for Treating Metastatic Uveal Melanoma WASHINGTON–(BUSINESS WIRE)–The Melanoma Research Alliance (MRA) … Continue reading → (..)

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Drug Discovery World

DECEMBER 1, 2023

Today’s approval will offer the first approved treatment option for patients beyond surgery and radiation.” This approval represents an important therapeutic advance for patients,” said Mrinal M Gounder, sarcoma medical oncologist at Memorial Sloan Kettering Cancer Center (MSK) in New York City and an investigator in the DeFi trial.

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Pharmaceutical Technology

MAY 26, 2023

As noted in the announcement, Rinvoq is the first approved oral product available to treat moderately to severely active CD, a significant point of distinction that will ultimately allow the therapy to be well positioned within the CD landscape.

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XTalks

FEBRUARY 3, 2023

It is currently the first and only FDA-approved non-covalent BTKi. “Until now, people living with MCL who can no longer be treated with BTK inhibitors have had few alternatives,” said Meghan Gutierrez, chief executive officer, Lymphoma Research Foundation, in Eli Lilly’s press release.

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Medical Xpress

DECEMBER 13, 2022

New research has confirmed a strong link between four genetic mutations and progressive multifocal leukoencephalopathy (PML), a rare but often fatal brain infection that can be triggered by dozens of FDA-approved drugs.

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FDA Approval Research Gene Genetics 98

pharmaphorum

JANUARY 12, 2023

Additionally, under its 2018 agreement, Avillion had regulatory responsibility, including filing the New Drug Application (NDA) through to FDA approval. The new approval continues the company’s unmarred success rate in clinical co-development partnerships across multiple therapeutic areas.

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XTalks

AUGUST 18, 2023

The FDA approval of Izervay is great news for the retina community and our patients suffering from geographic atrophy,” said Arshad M. Khanani, director of clinical research at Sierra Eye Associates, Reno, Nevada, in Iveric Bio’s news release.

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XTalks

FEBRUARY 26, 2024

The study included 168 pediatric and adult participants who were allergic to peanuts and at least two other foods, including milk, eggs, wheat, cashews, hazelnuts or walnuts.

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