XTalks

FEBRUARY 25, 2025

Mirum Pharmaceuticals, a biotech innovator known for developing therapies for rare metabolic disorders, now has FDA approval for its new treatment, Ctexli (chenodiol) tablets the first and only medication approved for cerebrotendinous xanthomatosis (CTX) in adults.

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XTalks

SEPTEMBER 12, 2023

Life science podcasts have emerged as an invaluable tool for building connections with audiences in the digital era. Furthermore, we’ll explore the unique advertising opportunities that this platform offers, positioning brands at the forefront of the life science industry. The result?

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XTalks

MARCH 25, 2021

Xtalks is proud to announce the launch of the Xtalks Life Science podcast. Subscribe to the Xtalks Life Science Podcast to never miss a new episode. Fresh Conversations About Life Science Topics. Diverse Voices for Lively Discussions. Sarah is also an experienced webinar moderator.

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Pharmaceutical Technology

FEBRUARY 13, 2023

While several therapeutics are available for treating symptoms associated with epilepsy, researchers and patients have strongly called out the need for more holistic treatments that would address the condition as a whole. Meanwhile, others are researching the link between gene variation and different responses to treatments.

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XTalks

DECEMBER 20, 2023

As we step into 2024, the life sciences continue to evolve at an unprecedented pace, driven by technological innovation, a deeper understanding of human biology and the application of new technologies in areas like drug development and health wearables. These companies are at various stages of research and clinical trials.

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XTalks

APRIL 21, 2023

And in 2015 the US Food & Drug Administration (FDA) approved an assay on Theranos’ proprietary technology.” Life science startups face unique challenges given the highly regulated and complex nature of the industry. Outsiders who reviewed the technology said it worked.

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XTalks

FEBRUARY 19, 2025

The dynamic landscape of TGCT research extends beyond Decipheras efforts. In October 2024, SynOx Therapeutics secured new investor capital raising its Series B total to $92 million and began dosing the first patients in its Phase III trial, underscoring the growing financial and clinical momentum in the field.

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XTalks

DECEMBER 22, 2021

If the past year is anything to go by, then 2022 will also be a year marked by continued innovations in the life sciences. Here is a look at some life science trends to expect in the coming year, including key themes and topics in the pharmaceutical, biotechnology and medical device industries to keep an eye out for in 2022.

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XTalks

APRIL 9, 2025

Building on its rapidfire approvals in rare kidney diseases most recently Fabhalta (iptacopan) earning a third FDA nod , most recently for C3 glomerulopathy Novartis now adds Vanrafia (atrasentan) to its nephrology portfolio.

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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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XTalks

JANUARY 5, 2021

In other research areas, innovations in the pharmaceutical, medical device and biotech industries will benefit from approaches such as artificial intelligence (AI) and increased digitization. Even more interestingly, now there are drugs that have FDA approval that were conducted by decentralized clinical trials.

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XTalks

AUGUST 12, 2024

Related: Asthma Drug Xolair Wins FDA Approval as First Treatment for Multiple Food Allergies “Today’s approval provides the first epinephrine product for the treatment of anaphylaxis that is not administered by injection. The availability of epinephrine nasal spray may reduce barriers to rapid treatment of anaphylaxis.

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XTalks

JANUARY 6, 2025

The US Food and Drug Administration (FDA) has approved Alyftrek (vanzacaftor/tezacaftor/deutivacaftor), a next-in-class triple combination cystic fibrosis transmembrane conductance regulator (CFTR) modulator, to treat cystic fibrosis (CF) in patients aged six years and older with at least one F508del mutation or another responsive CFTR mutation.

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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.

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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

DECEMBER 17, 2021

Xtalks is taking a look at some of the major stories and innovations of the year in the life sciences, many of which were driven by new, emerging and improved technologies. The year 2021 was all about continuing innovations in the life sciences. Life Science Innovations: Malaria and Influenza Vaccines.

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XTalks

NOVEMBER 13, 2024

XTALKS WEBINAR: Generative AI in Clinical Research: From Data to Patient Cohorts Live and On-Demand: Wednesday, December 11, 2024, at 1pm EST (10am PST) Register for this free webinar to learn how generative AI is revolutionizing clinical research from streamlining data abstraction to building more precise patient cohorts.

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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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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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XTalks

JANUARY 21, 2025

The approval makes Datroway AstraZenecas eighth new medicine since 2020, the first US approval for Daiichi Sankyo and AstraZenecas TROP2-directed ADC and the second based on their proprietary DXd technology. The FDA approval sent Daiichi Sankyos shares soaring by 8.7% to 4,437 yen, reflecting investor confidence.

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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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XTalks

JANUARY 26, 2023

This is the fourth US FDA approval that BeiGene has received for Brukinsa since 2019. Thanks to research that has delivered innovative and effective medicines, people with CLL can remain on therapy for years so tolerability is an important consideration.

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XTalks

DECEMBER 7, 2021

Related: How Researchers Stumbled Upon an Arthritis Vaccine Just in Time for World Arthritis Day. Prior to the FDA approval, PreHevbrio was only approved in Israel. PreHevbrio is the only three-antigen vaccine among the group. The shot demonstrated a good safety profile with no unexpected reactions.

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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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World of DTC Marketing

JANUARY 24, 2022

That investment, equal to the National Institutes of Health’s annual spending on medical research, would seem like great news for a world waiting for help with a pandemic. A group of early-stage life science investors and biotech CEOs joined together with a prominent patient advocate to speak out against H.R.3,

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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. Duvyzat received Priority Review, Orphan Drug and Rare Pediatric Disease designations from the FDA.

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XTalks

OCTOBER 4, 2022

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

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XTalks

APRIL 23, 2021

The therapy is indicated for endometrial cancer that has progressed during, or following, prior treatment with a platinum-based chemotherapy, and in women with dMMR tumors as determined by an FDA-approved test. The immunotherapy has also become the first targeted therapy for the dMMR positive subset of endometrial cancers.

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XTalks

MAY 5, 2022

There are four FDA-approved ADHD-specific nonstimulant drugs, namely Eli Lilly’s Strattera (atomoxetine), Shionogi’s Kapvay (clonidine), Takeda’s Intuniv (guanfacine) and now Supernus’ Qelbree (viloxazine). In 2002, Strattera became the first FDA-approved nonstimulant drug to treat ADHD in adults.

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XTalks

JULY 14, 2022

Register for this free webinar for expert insights and an engaging discussion surrounding the utilization of electronic health record (EHR) data in clinical research and what the future might hold. Related: Vtama (tapinarof) Cream Gains FDA Approval for the Treatment of Plaque Psoriasis in Adults.

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XTalks

MAY 11, 2022

Ayesha also talked about a new ovarian cancer blood test developed by researchers at the University of Manchester that may help diagnose the disease quicker and more accurately, especially in younger women. The episode marked World Ovarian Cancer Day and was sponsored by Elligo Health Research.

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XTalks

OCTOBER 4, 2022

Rolvedon is the first long-acting granulocyte colony-stimulating factor (GCSF) to be FDA-approved in over 20 years that is not a biosimilar. Equipped with extensive long-acting growth factor market experience, customer connectivity and learnings from in-depth market research insights, we are ready to optimize the launch trajectory.

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XTalks

NOVEMBER 16, 2022

has won US Food and Drug Administration (FDA) approval for its antibody-drug conjugate (ADC) Elahere (mirvetuximab soravtansine-gynx) for the treatment of platinum-resistant ovarian cancer. The drug was approved under the FDA’s accelerated pathway and is indicated for adult patients with folate receptor alpha (FR?)-positive

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XTalks

SEPTEMBER 19, 2024

World Cancer Research Day 2024, observed on September 24, highlights innovation under the theme “Innovation In Cancer Research Drives Progress Toward Health Equity.” 2024 has seen significant US Food and Drug Administration (FDA) approvals that are pushing the boundaries of cancer treatment.

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XTalks

JUNE 2, 2021

KRAS mutations have previously been considered ‘undruggable’ targets, but they have been a big focus in cancer research as they are one of the most common gene mutations across all cancers. The sotorasib approval is therefore a major breakthrough in the world of cancer and targeted therapies.

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XTalks

DECEMBER 20, 2023

In 2023, there were significant advancements and notable trends in the life sciences. Xtalks compiled a list of its top life science news and trends of 2023, which provided readers with the latest developments, information and expert insights across life science industries, including pharma, biotech and medical device.

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XTalks

APRIL 27, 2022

Gilead’s Veklury (remdesivir) gets FDA approval to treat young children with COVID-19 and becomes the first and only approved COVID-19 treatment for children under 12. The FDA highlighted that Veklury is not a substitute for vaccination in people eligible for COVID-19 vaccination and booster doses.

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