XTalks

FEBRUARY 15, 2023

Bastiaan Driehuys, PhD Founder and Chief Technology Officer Polarean Imaging plc In this week’s Xtalks Life Science podcast episode, Ayesha and the editorial team spoke with Dr. Bastiaan Driehuys, Founder and Chief Technology Officer at Polarean Imaging plc. Subscribe to the Xtalks Life Science Podcast to never miss a new episode.

Life Science 98

Life Science FDA Approval Drugs Production 98

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.

FDA Approval 59

FDA Approval Gene Therapy Gene Genetics 59

XTalks

SEPTEMBER 14, 2022

In this episode, Ayesha discussed the FDA approval of Sanofi’s enzyme replacement therapy Xenpozyme for the treatment of non-central nervous system (non-CNS) manifestations of acid sphingomyelinase deficiency (ASMD), a rare genetic lysosomal storage disease, in adults and pediatric patients.

Life Science 90

Life Science FDA Approval Insulin Drugs 90

Pharmaceutical Technology

APRIL 12, 2024

SK Life Sciences Xcopri (cenobamate) is approved as an oral suspension mixed with water for mouth administration or via a nasogastric tube.

FDA Approval 130

FDA Approval Life Science 130

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.

Life Science 119

Life Science Gene Editing Development Clinical Trials 119

XTalks

AUGUST 23, 2023

BriaCell recently received FDA approval for its Bria-IMT Combination pivotal study design in advanced metastatic breast cancer. Subscribe to the Xtalks Life Science Podcast to never miss a new episode.

Life Science 98

Life Science Clinical Trials Clinical Trials FDA Approval 98

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.

FDA Approval 59

FDA Approval Clinical Trials Clinical Trials Trials 59

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.

Life Science 98

Life Science Trials Production Regulation 98

XTalks

FEBRUARY 19, 2025

The FDA has approved Decipheras Romvimza (vimseltinib) for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) when surgery may lead to worsened joint function or severe complications. The approval was largely based on the results of the MOTION Phase III study.

FDA Approval 59

FDA Approval Drugs Trials Clinical Trials 59

XTalks

MARCH 3, 2022

Developed in partnership with Legend Biotech Corp of China, Johnson & Johnson’s cell therapy Carvykti (formerly known as cilta-cel) received approval from the US Food and Drug Administration (FDA) this week for the treatment of multiple myeloma. Live and On-Demand: March 16, 2022 | 9am EDT (NA) / 1pm GMT (UK).

FDA Approval 98

FDA Approval Life Science Production Trials 98

XTalks

NOVEMBER 28, 2023

This liquid formulation of metronidazole is the sole FDA-approved liquid option, offering a groundbreaking prescribing alternative for patients encountering difficulties in swallowing or facing taste-related obstacles. With a 24-month shelf life and no need for refrigeration, Likmez provides a convenient option for patients.

FDA Approval 103

FDA Approval Bacteria DNA Drugs 103

XTalks

JANUARY 2, 2024

For instance, Vyjuvek , the first FDA-approved gene therapy for DEB, is priced at $24,250 per vial. a biotech company specializing in the development and commercialization of genetic medicines for rare diseases, announced FDA approval for Vyjuvek for the treatment of DEB.

FDA Approval 111

FDA Approval Gene Therapy Gene Trials 111

XTalks

MARCH 30, 2022

This includes the company’s bestselling epilepsy drug Epidiolex, which is the first FDA-approved cannabis-based medication. Subscribe to the Xtalks Life Science Podcast to never miss a new episode. Jazz Pharma Announces $100 Million “Green” Manufacturing Plant for Cannabis-Based Medicines.

Life Science 93

Life Science Manufacturing FDA Approval Drugs 93

XTalks

NOVEMBER 27, 2024

Syndax Pharmaceuticals’ Revuforj (revumenib) has won US Food and Drug Administration (FDA) approval for the treatment of relapsed or refractory (R/R) acute leukemia in patients aged one year and older who have a lysine methyltransferase 2A ( KMT2A, formerly MLL ) gene translocation.

FDA Approval 99

FDA Approval Drugs Gene Trials 99

XTalks

JANUARY 3, 2024

Wainua is the only FDA-approved drug for the treatment of ATTRv-PN that can be self-administered via an auto-injector. Approval of Wainua represents a meaningful advancement in treatment, one that gives those who are living with transthyretin-mediated amyloid polyneuropathy help managing the disease,” said Michael J.

FDA Approval 105

FDA Approval Protein RNA Clinical Trials 105

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

XTalks

MARCH 15, 2023

Subscribe to the Xtalks Life Science Podcast to never miss a new episode. Read more here: Lenire Bimodal Neuromodulation Device by Neuromod Improves Tinnitus Symptoms in Clinical Trial The weekly podcast is available for streaming every Wednesday on Spotify , Apple Music and wherever you stream your podcasts.

Life Science 75

Life Science FDA Approval Engineer Clinical Trials 75

FDA Law Blog

JUNE 27, 2023

James was only one of five life sciences attorneys selected and the only food and drug lawyer to make the list. Amongst his accomplishments, Law360 considered the role James has played in leveraging little-used pathways to FDA approval for often first-ever drugs to treat rare diseases (e.g., HP&M’s Kurt R.

Life Science 81

Life Science FDA Approval Drugs Development 81

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.

FDA Approval 105

FDA Approval Allergies Production Drugs 105

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.

FDA Approval 98

FDA Approval Production Insulin Antibody 98

XTalks

SEPTEMBER 6, 2022

On Friday, Azurity Pharmaceuticals announced that the US Food and Drug Administration (FDA) approved their innovative oral liquid formulation Konvomep (omeprazole and sodium bicarbonate for oral suspension). John’s University College of Pharmacy & Health Sciences, Queens, New York.

FDA Approval 98

FDA Approval Containment Pharmacy Medicine 98

XTalks

MAY 2, 2022

This is the very first approval for a medication for the chronic version of VVC. The approval is a significant breakthrough for RVVC as it is a condition with significant unmet need. For Mycovia Pharmaceuticals , Vivjoa is the company’s first FDA-approved drug in its pipeline of novel treatments for fungal infections.

FDA Approval 98

FDA Approval Drugs Clinical Trials Clinical Trials 98

XTalks

OCTOBER 16, 2024

Hympavzi’s approval, with its innovative approach to balancing clotting, could offer a modern solution that adds to the global effort to reduce the risk of thrombosis. This is Pfizer’s second FDA-approved treatment for a rare genetic blood disorder this year.

FDA Approval 105

FDA Approval Trials Clinical Trials Clinical Trials 105

XTalks

JANUARY 26, 2023

This is the fourth US FDA approval that BeiGene has received for Brukinsa since 2019. Brukinsa is also indicated to treat adults with Mantle cell lymphoma, Waldenström’s macroglobulinemia and relapsed or refractory marginal zone lymphoma.

FDA Approval 97

FDA Approval Life Science Clinical Trials Clinical Trials 97

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.

Botox 98

Botox FDA Approval Cosmetics Clinical Trials 98

XTalks

AUGUST 14, 2024

The guidelines now recommend CAMZYOS (mavacamten), the first and only FDA approved cardiac myosin inhibitor, as a Class 1 Level B-R therapy for the treatment of adults with obstructive HCM who have persistent symptoms after first-line therapy. Subscribe to the Xtalks Life Science Podcast to never miss a new episode.

Life Science 72

Life Science Cardiology FDA Approval Medicine 72

XTalks

OCTOBER 18, 2022

Global medical device company Nevro Corp has received US Food and Drug Administration (FDA) approval for the Senza HFX iQ spinal cord stimulation (SCS) system for the treatment of long-term or chronic pain. HFX iQ is designed to improve the consistency of pain relief and is the only SCS system that truly personalizes care,” said D.

FDA Approval 98

FDA Approval Big Data Life Science Clinical Trials 98

XTalks

MARCH 9, 2023

The efficacy data used for the FDA-approved label is based on post-hoc sensitivity analysis evaluating only the first 281 randomized patients in the trial. There are risks associated with birth defects and liver harm, so Filspari is only available through an FDA-approved Risk Evaluation and Mitigation Strategy.

FDA Approval 98

FDA Approval Drugs Clinical Trials Clinical Trials 98

XTalks

APRIL 3, 2024

Related: Novartis’ Fabhalta Gets FDA Approval for Rare Complement Blood Disorder The FDA’s green light for Voydeya comes three months after the Japanese Ministry of Health, Labour and Welfare (JHLW) became the first regulator in the world to back the therapy.

FDA Approval 102

FDA Approval Sales Trials Development 102

XTalks

APRIL 15, 2025

Soleno Therapeutics has announced the FDA approval of Vykat XR (diazoxide choline extended-release tablets) for the treatment of hyperphagia an intense, persistent hunger in patients with Prader-Willi syndrome (PWS). The approval marks the first FDA-approved therapy specifically targeting hyperphagia in this rare genetic disorder.

FDA Approval 59

FDA Approval Clinical Trials Clinical Trials Trials 59

XTalks

AUGUST 7, 2023

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. Formerly known as VP-102, Ycanth is the first cantharidin formulation approved for this purpose. Another noteworthy contender is Novan Inc.’s

FDA Approval 98

FDA Approval Dermatology Trials Clinical Trials 98

XTalks

OCTOBER 4, 2022

The life expectancy of HRS-affected patients is very low, and the only definitive treatment is liver transplantation. “Diagnosing and treating HRS can be challenging, and every minute counts when managing patients who have it.

FDA Approval 98

FDA Approval Clinical Trials Clinical Trials Trials 98

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.

Gene Therapy 105

Gene Therapy Protein Genetic Disease Gene 105

XTalks

JULY 25, 2023

Efficacy of Cyfendus The FDA approval of the Cyfendus anthrax vaccine is grounded in a series of studies supported by the US government and carried out by Emergent. Other Anthrax Vaccines and Treatments In addition to Cyfendus, several other vaccines and treatments have received FDA approval to combat Anthrax.

FDA Approval 98

FDA Approval Vaccination Vaccine Antibody 98

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.

FDA Approval 98

FDA Approval Drugs Clinical Trials Clinical Trials 98

XTalks

JANUARY 13, 2023

FDA approval represents achievement of a major milestone for Polarean’s technology. In the US, about 37 million people live with chronic lung disorders such as chronic obstructive pulmonary disease (COPD) and asthma.

FDA Approval 105

FDA Approval Packaging Packaging Clinical Trials 105

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.

Antibody 105

Antibody FDA Approval HR Trials 105