XTalks

JANUARY 26, 2023

This is the fourth US FDA approval that BeiGene has received for Brukinsa since 2019. BTK plays an important role in the immune system by regulating B cell receptor signaling through its effects on the development and maturation of B cells.

FDA Approval 97

FDA Approval Life Science Clinical Trials Clinical Trials 97

XTalks

SEPTEMBER 12, 2022

Sanofi picked up its first Xenpozyme approval for the treatment of Niemann-Pick from Japanese regulators in March followed by an approval from European officials in May. The FDA approval was based on data from the randomized, double-blind, placebo-controlled ASCEND study involving 31 adult patients.

FDA Approval 98

FDA Approval Genetics Trials Gene 98

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.

FDA Approval 105

FDA Approval Genetics Gene Therapy Gene 105

XTalks

NOVEMBER 15, 2024

These RXR receptors play a key role in regulating transcription pathways involved in inflammation and immune responses, among other cancer hallmarks, to modulate the tumor microenvironment. Tamibarotene is a selective agonist of retinoic acid receptor alpha/beta, with potential binding to retinoid X receptors (RXR).

Trials 105

Trials HR Immune Response FDA Approval 105

XTalks

JUNE 2, 2021

The sotorasib approval is therefore a major breakthrough in the world of cancer and targeted therapies. The oral treatment was approved for adults with locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy.

FDA Approval 97

FDA Approval Clinical Trials Clinical Trials Trials 97

XTalks

APRIL 21, 2021

More cases of blood clots in those vaccinated against COVID-19 — this time in six women who took the J&J shot — has US regulators recommending that vaccination efforts be paused. Read the full articles here: First Non-Surgical Heart Valve Wins FDA Approval for Severe Pulmonary Valve Regurgitation.

Life Science 52

Life Science Vaccination Vaccine FDA Approval 52

XTalks

JANUARY 28, 2022

Kimmtrak has also become the first bispecific T cell engager to be FDA-approved for the treatment of a solid tumor. Immunocore received Breakthrough Device Designation for Kimmtrak from the FDA in February 2021 followed by acceptance of its Biologics License Application (BLA) several months later by both US and European regulators.

FDA Approval 98

FDA Approval Development Containment Licensing 98

XTalks

DECEMBER 29, 2022

The life sciences and healthcare are among the biggest industries globally, and their significance was particularly highlighted during the past couple of years by the COVID-19 pandemic. Given the hyperfocus on the life sciences thanks to COVID, consumers appear to be more autonomous and vocal about their medical demands and choices.

Life Science 52

Life Science Gene Therapy Gene Manufacturing 52

pharmaphorum

SEPTEMBER 3, 2020

In a filing with the US financial regulator Compass laid out its plans to develop the drug known as COMP360, which is a crystalline formulation of psilocybin in phase 2b clinical development in patients who have not responded to standard therapy for depression. Another was hospitalised with suicidal ideation.

Drugs 116

Drugs Life Science Clinical Development Regulation 116

XTalks

FEBRUARY 18, 2025

Biosimilars are biological products highly similar to an already FDA-approved reference product, with no clinically meaningful differences in terms of safety, purity and potency. million Americans depend on insulin therapy either rapid-acting, long-acting or both to regulate their blood sugar. Approximately 8.4

Insulin 59

Insulin FDA Approval Production Hormones 59

XTalks

OCTOBER 6, 2020

The US Food and Drug Administration (FDA) has given approval to Janssen Pharmaceutical for Simponi Aria (golimumab) in the treatment of patients two years of age and older with active polyarticular juvenile idiopathic arthritis (pJIA). FDA approval for the treatment was based on results from the Phase III GO-VIVA clinical trial.

FDA Approval 71

FDA Approval Clinical Trials Clinical Trials Trials 71

XTalks

DECEMBER 18, 2024

Currently, the standard treatment for CAH involves glucocorticoids, which replace cortisol and help regulate hormone levels. While manageable, the condition requires lifelong treatment and monitoring to prevent complications and ensure healthy development.

Genetics 116

Genetics Hormones Trials Drugs 116

XTalks

JANUARY 3, 2025

For the first time in the US, adults living with familial chylomicronemia syndrome (FCS) have an FDA-approved treatment option. FCS also severely impacts quality of life, causing chronic fatigue and recurrent stomach pain. Tryngolza works by targeting a protein in the liver, apoC-III, which regulates triglyceride metabolism.

FDA Approval 59

FDA Approval Drugs Clinical Trials Clinical Trials 59

XTalks

MARCH 28, 2024

The US Food and Drug Administration (FDA) has given the nod to Winrevair (sotatercept-csrk injection, 45mg, 60mg) for the treatment of adults with pulmonary arterial hypertension (PAH) to increase exercise capacity, improve WHO (World Health Organization) functional class (FC) and reduce the risk of clinical worsening events.

FDA Approval 81

FDA Approval Clinical Trials Clinical Trials Trials 81

XTalks

JANUARY 25, 2023

Massachusetts-based TheracosBio has received US Food and Drug Administration (FDA) approval for diabetes med Brenzavvy (bexagliflozin) to help improve glycemic control in adults with type 2 diabetes. It is the first FDA-approved SGLT2 inhibitor for any animal species.

FDA Approval 52

FDA Approval Drugs Life Science Cosmetics 52

XTalks

DECEMBER 9, 2024

The US Food and Drug Administration (FDA) has released a new draft guidance titled Expedited Program for Serious Conditions Accelerated Approval of Drugs and Biologics Guidance for Industry refining the accelerated approval pathway for drugs and biologics targeting serious or life-threatening conditions.

Clinical Trials 105

Clinical Trials Clinical Trials Compliance Trials 105

XTalks

DECEMBER 2, 2022

As the first FDA-approved fecal microbiota product, (the) action represents an important milestone, as it provides an additional approved option to prevent recurrent CDI,” said Peter Marks, director of the agency’s Center for Biologics Evaluation and Research (CBER). Rebyota is not indicated for the first occurrence of C.

FDA Approval 59

FDA Approval Bacteria Clinical Trials Clinical Trials 59

XTalks

FEBRUARY 5, 2024

In the dynamic landscape of oncology therapeutics, understanding the trends and performances of leading drugs is crucial for stakeholders across the healthcare and life sciences sectors. The top 40 best-selling oncology drugs in 2023, informed by 2022 sales statistics, mark significant milestones in cancer treatment and research.

FDA Approval 101

FDA Approval Drugs Sales Development 101

XTalks

NOVEMBER 10, 2023

cTTP is a very rare, inherited and life-threatening blood clotting disorder caused by a disease-causing mutation in the ADAMTS13 (A disintegrin and metalloproteinase with thrombospondin motifs 13) gene, which encodes the ADAMTS13 enzyme that regulates blood clotting by cleaving the von Willebrand factor (VWF) protease.

FDA Approval 59

FDA Approval Gene Therapy Gene Clinical Trials 59

XTalks

OCTOBER 27, 2022

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the US Food and Drug Administration (FDA) approved Tecvayli (teclistamab-cqyv) for the treatment of relapsed or refractory multiple myeloma. The FDA approval of Tecvayli makes it the first bispecific BCMA-directed CD3 T-cell engager approved in the US.

FDA Approval 52

FDA Approval Antibody Drugs Trials 52

XTalks

NOVEMBER 1, 2022

Rinvoq received its sixth FDA approval, this time it is for treating adults with non-radiographic axial spondyloarthritis, a form of inflammatory arthritis that affects the spine. JAK inhibitors block cell signaling that cause inflammation, providing patients an alternative method to regulating an overactive immune system.

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials DNA 52

pharmaphorum

JULY 19, 2021

Over 50% identified a better understanding of complex medicines by regulators as key to developing this field. Recent successes in FDA approvals of antibody–drug conjugates (ADCs), RNA therapeutics and the UK’s regulatory leadership in coronavirus vaccines show that complex medicines are having a global impact.

Life Science 52

Life Science Medicine RNA Vaccination 52

XTalks

MARCH 10, 2023

This US Food and Drug Administration (FDA)-approved drug was also awarded a rare pediatric disease priority review voucher. Previous animal model studies of Friedreich’s ataxia showed a dysfunction in the regulation of Nrf2 signaling, a pathway associated with reduced inflammatory response and improved mitochondrial function.

FDA Approval 52

FDA Approval Engineer Clinical Trials Clinical Trials 52

XTalks

AUGUST 19, 2021

With the FDA green light, Xywav has become the first drug approved for IH. This, despite the drug having strict regulations and safety concerns. GHB has now become a strictly regulated medication for treating narcolepsy, which is also associated with excessive daytime sleepiness.

FDA Approval 64

FDA Approval Drugs Regulation Sales 64

XTalks

JUNE 12, 2023

Recent FDA Approvals of Cell Therapy Manufacturing Facilities in the US Successful commercialization of novel cell therapy requires exemplary performance at all stages, including upstream and downstream processing, process development, testing and manufacturing services.

Manufacturing 95

Manufacturing Gene Therapy FDA Approval Gene 95

XTalks

FEBRUARY 21, 2025

Related: Obesity-Focused Metsera Launches IPO Amid Much Anticipation Aardvarks approach centers on developing novel, small-molecule drugs that harness the bodys natural hunger-regulating mechanisms.

Genetics 59

Genetics Hormones Gene Expression Gene 59

XTalks

APRIL 6, 2023

Mounjaro (tirzepatide) is a dual glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) agonist, which makes it the first-in-class drug that activates both receptors to help regulate blood sugar and appetite. Lilly is, however, expecting an FDA approval later this year for a weight loss version of Mounjaro.

FDA Approval 97

FDA Approval Regulation Drugs Trials 97

Pharmaceutical Technology

NOVEMBER 29, 2022

In 1970, the FDA approved ketamine as an anesthetic. In March 2019, the American regulator approved esketamine , an enantiomer of ketamine, for use in treatment-resistant depression as a nasal spray. The drug is also known for its illegal recreational use.

Research 275

Research Trials Drugs Generic Drugs 275

XTalks

JULY 10, 2023

Euronext Brussels (UCB), a biopharma company headquartered in Brussels, Belgium, recently announced that the US Food and Drug Administration (FDA) has granted approval for its drug, Rystiggo (rozanolixizumab), for the treatment of generalized myasthenia gravis (gMG).

FDA Approval 98

FDA Approval Antibody Protein Engineer 98

XTalks

SEPTEMBER 16, 2022

Tyrosine kinases are enzymes that regulate signaling pathways with downstream effects on cell growth, differentiation and death. The FDA approval of a new oral treatment is exciting news for the psoriasis community. Phototherapy involves the use of ultraviolet irradiation to slow skin growth and lower inflammation.

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials Trials 52

XTalks

SEPTEMBER 17, 2021

The ALS Association is pushing for rapid FDA approval of Amylyx Pharmaceuticals Inc.’s Accelerated FDA Approval Modeled on Aduhelm. This has brought criticism that US regulators are moving too slow on a drug that has clinical promise and is being backed by other international regulators.

Trials 98

Trials Drugs FDA Approval Clinical Trials 98

XTalks

APRIL 29, 2022

Tirzepatide is a novel investigational obesity treatment that contains mimetics of two hormones that are involved in regulating appetite in a single peptide: a GIP (glucose-dependent insulinotropic polypeptide) receptor agonist and a GLP-1 (glucagon-like peptide-1) receptor agonist. percent and 22.5 percent, respectively, compared to placebo.

Trials 98

Trials Drugs FDA Approval Clinical Trials 98

XTalks

MARCH 22, 2023

In October 2022, Xtalks celebrated two decades of bringing diverse stakeholders in the life science industry together through first holding physical events, then soon after, hosting exclusively online events. Just last year, the FDA approved a one-time gene therapy treatment for hemophilia B priced at $3.5

Life Science 97

Life Science Drugs FDA Approval Vaccination 97

XTalks

SEPTEMBER 4, 2024

Gudeman helped continue the clinical development of Lumryz (sodium oxybate) through to its approval, which was approved last May and is the first and only FDA approved once-at-bedtime oxybate for individuals living with narcolepsy. Narcolepsy affects the brain’s ability to regulate sleep-wake cycles.

Life Science 52

Life Science Clinical Development FDA Approval Regulation 52

XTalks

JULY 11, 2024

Susvimo, a refillable eye implant, received US Food and Drug Administration (FDA) approval in 2021, but its initial rollout faced challenges due to septum dislodgement cases that prompted Roche to issue a voluntary market recall in October 2022. In the first quarter of 2024, Vabysmo sales leaped 108 percent to $927.4

FDA Approval 104

FDA Approval Clinical Trials Clinical Trials Sales 104

pharmaphorum

AUGUST 31, 2021

For the innovators and early adopters of the life sciences industry, engineering a regulatory-grade ECA can be daunting. The industry has looked to regulators for guidance, and the Food and Drug Administration (FDA) has been quick to respond. Myth 1: There are too many challenges with adopting an ECA.

Clinical Trials 89

Clinical Trials Clinical Trials Life Science Trials 89

XTalks

MAY 5, 2023

This week, the US Food and Drug Administration (FDA) approved the world’s first respiratory syncytial virus (RSV) vaccine. The shot, named Arexvy, is approved for adults aged 60 years and older and was developed by GlaxoSmithKline (GSK). Who Should Get the RSV Vaccine Arexvy?

Vaccination 105

Vaccination Vaccine FDA Approval Development 105