XTalks

NOVEMBER 7, 2024

Research suggests that certain bacteria, particularly those associated with Demodex mites (tiny mites that naturally live on human skin) like Bacillus oleronius , could contribute to rosacea in some individuals. Emrosi consists of minocycline, a tetracycline antibiotic, to target bacterial infection that can underlie rosacea.

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FDA Approval Dermatology Bacteria Clinical Trials 105

XTalks

APRIL 1, 2025

Clinical Trials Backing Qfitlias Approval Two Phase III studies involving adult and pediatric male patients with hemophilia A or B supported Qfitlias FDA approval. Qfitlia is the second RNA interference therapy to receive a highly anticipated FDA approval recently. billion ($1.4 billion) in sales by 2029.

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FDA Approval RNA Clinical Trials Clinical Trials 59

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 258

XTalks

OCTOBER 24, 2024

Trends in Psoriasis Research: Biologics, Biosimilars and New Therapies Recent innovations in biologics and biosimilars have transformed psoriasis care. The Psoriasis Diet Diet has long been an area of research as a potential factor in managing psoriasis.

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Research Dermatology Clinical Trials Clinical Trials 105

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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FDA Approval Research Drugs 207

XTalks

NOVEMBER 12, 2024

November is Pancreatic Cancer Awareness Month , a time dedicated to increasing public understanding of this challenging disease, supporting patients and their families and advancing research for better treatment options. For this reason, researchers are working hard to find new methods to identify pancreatic cancer sooner.

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Research FDA Approval Trials Clinical Trials 105

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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FDA Approval Drugs Research 281

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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FDA Approval Drugs Medicine Clinical Trials 245

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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FDA Approval Gene Therapy Gene Genetics 59

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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FDA Approval Hormones Trials Clinical Trials 244

XTalks

JANUARY 21, 2025

TriClip G4 System Manufacturer/developer : Abbott Medical Date of FDA approval : April 1, 2024 Approved for : Tricuspid regurgitation (TR). Date of FDA approval : March 29, 2024 Approved for : To detect exposure to human parvovirus B19. TriClip size comparison photo. Photo courtesy of Abbott Medical.

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Pharmaceutical Technology

OCTOBER 10, 2022

FDA Center for Biologics Evaluation and Research director Peter Marks said: “Pertussis disease is a highly contagious respiratory illness affecting all age groups. The post US FDA approves GSK’s pertussis vaccine to protect newborn appeared first on Pharmaceutical Technology.

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FDA Approval Vaccine Vaccination Antibody 147

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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Research Gene Gene Therapy Genomics 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).

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FDA Approval Genetics Trials Medicine 130

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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FDA Approval Drugs Protein Antibody 180

Pharmaceutical Technology

AUGUST 25, 2022

The latest FDA approval is said to be the company’s first paediatric indication for Imbruvica, which is also the first BTK inhibitor to receive approval in paediatric patients. The post US FDA approves AbbVie-Janssen’s Imbruvica for cGVHD in children appeared first on Pharmaceutical Technology.

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FDA Approval Clinical Trials Clinical Trials Protein 130

Pharmaceutical Technology

MAY 22, 2023

Continued approval for the indication is dependent on verification and description of the clinical benefit of Epkinly in confirmatory trials. AbbVie research and development senior vice-president and chief scientific officer Thomas Hudson stated: “DLBCL is an aggressive cancer type that can rapidly progress and resist treatment.

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FDA Approval Clinical Trials Clinical Trials Antibody 130

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 119

Pharmaceutical Technology

AUGUST 12, 2022

In the lead-up to a critical meeting that will influence the approval of a new drug for amyotrophic lateral sclerosis (ALS), the US Food and Drug Administration (FDA) has detailed its plans to advance rare neurodegenerative disease research. Thus, FDA funding could be what is needed on this front, says Cudkowicz.

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Research Gene Therapy Drugs Trials 246

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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FDA Approval Drugs Trials Clinical Trials 59

Pharmaceutical Technology

MAY 10, 2023

According to the US government, Gilead had repeatedly refused to license patents related to PrEP research undertaken by the Department of Health and Human Services’ (HHS) Centers for Disease Control and Prevention (CDC). This research dates to the mid-2000s when CDC scientists developed the PrEP regimen, argued the government.

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Drugs FDA Approval Containment Licensing 264

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 14, 2023

The US Food and Drug Administration has approved a fast-acting nasal spray from Pfizer designed to treat migraines, the US pharmaceutical giant said Friday.

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FDA Approval Pharmacy Marketing Drugs 246

CTTI (Clinical Trials Transformation Initiative)

MARCH 19, 2025

A new publication from the FDA Oncology Center of Excellence (OCE) and the Clinical Trials Transformation Initiative (CTTI), published in the Clinical Cancer Research journal, provides important insights into how decentralized clinical trial (DCT) elements were used in cancer trials leading to FDA approval during the COVID-19 pandemic.

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Clinical Trials Clinical Trials Trials FDA Approval 75

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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FDA Approval Clinical Trials Clinical Trials Trials 97

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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FDA Approval Allergies Production Drugs 105

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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FDA Approval Production Clinical Development Manufacturing 147

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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Life Science FDA Approval Drugs Production 98

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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FDA Approval Clinical Trials Clinical Trials Cardiology 105

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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FDA Approval Trials Clinical Trials Clinical Trials 101

pharmaphorum

MAY 16, 2022

Patrick Archdeacon, associate director of the Division of Diabetes, Lipid Disorders, and Obesity at the FDA’s Centre for Drug Evaluation and Research, praised the medication. The post Lilly’s new drug Mounjaro (tirzepatide ) wins US FDA approval appeared first on.

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FDA Approval Insulin Drugs Hormones 115

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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FDA Approval Clinical Trials Clinical Trials Production 98

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

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

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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FDA Approval Packaging Packaging Clinical Trials 105

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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FDA Approval Clinical Trials Clinical Trials Trials 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.

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FDA Approval Genetics Gene Therapy Gene 105

Pharmaceutical Technology

MAY 15, 2023

The US Food and Drug Administration (FDA) has approved Astellas Pharma’s Veozah (fezolinetant) for use against moderate to severe vasomotor symptoms caused by menopause on May 12 after some delays due to an extended review. Since then, further research shows that younger women are at lesser risk.

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Hormones FDA Approval Licensing Licensing 244