XTalks

MAY 10, 2023

In this episode, Ayesha talked about the FDA approval of the world’s first vaccine for respiratory syncytial virus (RSV). The vaccine is approved for adults 60 years of age and older. Ayesha and the team also discussed the FDA approval of Qalsody (tofersen), a novel, first-of-its-kind treatment for ALS.

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Life Science Vaccination Vaccine FDA Approval 52

XTalks

JULY 20, 2022

In this episode, Ayesha discussed the FDA authorization of Novavax’s COVID-19 vaccine, making it the fourth authorized/approved COVID vaccine in the US. It is also the first protein-based COVID-19 vaccine to be authorized in the country. Krystexxa Chronic Gout Medication Gets Expanded FDA Approval.

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XTalks

JULY 25, 2023

Cyfendus functions by stimulating the production of antibodies targeted against the protective antigen protein. 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.

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FDA Approval Vaccination Vaccine Antibody 98

XTalks

JANUARY 26, 2023

This is the fourth US FDA approval that BeiGene has received for Brukinsa since 2019. Tyrosine Kinase Inhibitors for Cancer Treatment Tyrosine kinases, or TKs, are a group of signaling molecules that affect multiple downstream proteins.

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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

XTalks

DECEMBER 13, 2023

The disease occurs due to a point mutation in the hemoglobin beta globin ( HBB ) gene that codes for one of the proteins that make up hemoglobin, the oxygen carrier in red blood cells. It also affects Hispanic Americans, but at a lower prevalence. The mutation causes red blood cells to develop a crescent or “sickle” shape.

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XTalks

AUGUST 14, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that its bispecific antibody Talvey (talquetamab-tgvs) received US Food and Drug Administration (FDA) approval as a fifth-line treatment for adult patients with heavily pretreated multiple myeloma.

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FDA Approval Antibody Immune Response Drugs 97

XTalks

NOVEMBER 10, 2023

The US Food and Drug Administration (FDA) has approved Takeda Pharmaceuticals’ Adzynma, the first recombinant protein product for prophylactic (preventive) or on‑demand enzyme replacement therapy (ERT) in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP), an ultra-rare blood clotting disorder.

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XTalks

OCTOBER 4, 2022

“Rolvedon’s approval marks Spectrum’s transformation to a commercial-stage company with the opportunity to compete in a $2 billion dollar market, and offers a unique value proposition,” said Tom Riga, President and Chief Executive Officer of Spectrum Pharmaceuticals, in the company’s press release. How Does Rolvedon Work?

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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. Avacincaptad pegol can bind to and inhibit the complement protein C5, preventing the cleavage of C5 into C5a and C5b and significantly reducing membrane attack complex (MAC) formation.

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XTalks

JUNE 8, 2022

These autoantibodies include rheumatoid factor and antibodies against post-translational modified proteins such as carbamylation (anti-CarP antibodies) and citrullination (anti-citrullinated protein antibodies [ACPA]). This marks a new indication for Riabni, the fifth FDA-approved biosimilar by the biopharma Amgen.

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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

MAY 4, 2022

Bristol Myers Squibb (BMS) was granted US Food and Drug Administration (FDA) approval for its highly awaited cardiac drug Camzyos (mavacamten) for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (HCM). The FDA approved 2.5

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XTalks

APRIL 11, 2024

After backing from the US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) last month, Johnson and Johnson (J&J) and Bristol Myers Squibb (BMS) scored FDA approvals for the use of their B-cell maturation antigen (BCMA)-targeting CAR T-cell therapies as earlier line treatment options for multiple myeloma.

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FDA Approval Manufacturing Trials Clinical Trials 52

XTalks

MAY 26, 2022

The US FDA approved Dupixent (dupilumab) developed by Regeneron as the first treatment for eosinophilic esophagitis, a chronic immune disorder that damages the esophagus. These proteins cause the type 2 inflammation characteristic of EoE and related allergic diseases like asthma and atopic dermatitis (both treated with Dupixent).

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XTalks

MARCH 10, 2023

This US Food and Drug Administration (FDA)-approved drug was also awarded a rare pediatric disease priority review voucher. It is caused by a mutation in the FXN gene , which is responsible for the production of the protein frataxin.

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XTalks

JANUARY 5, 2021

The test identifies SARS-CoV-2 protein fragments from nasal swab samples. Even more interestingly, now there are drugs that have FDA approval that were conducted by decentralized clinical trials. AI is expected to make significant strides in the life science and healthcare sectors in 2021.

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XTalks

FEBRUARY 27, 2024

Iovance Biotherapeutics’ Amtagvi (lifileucel) won US Food and Drug Administration (FDA) approval last week for the treatment of advanced melanoma, making it the first individualized tumor-infiltrating lymphocyte (TIL) therapy and the first T-cell therapy for a solid tumor to win US regulatory approval.

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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.

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The Pharma Data

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. Pfizer’s COVID-19 therapy Paxlovid, for example, targets Mpro.

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XTalks

DECEMBER 27, 2022

Ferring Pharmaceuticals announced that the US Food and Drug Administration (FDA) approved Adstiladrin (nadofaragene firadenovec-vncg) for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

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Gene Therapy FDA Approval Gene Clinical Trials 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. Kimmtrak is a bispecific protein that contains a soluble T cell receptor fused to an anti-CD3 immune-effector function. Uveal melanoma is a rare and aggressive type of melanoma of the eye.

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XTalks

SEPTEMBER 16, 2022

The first protein kinase inhibitor was approved in 2001 to treat chronic myelogenous leukemia, and since then, over 50 TKIs have been approved by the FDA for a variety of cancer types. Normally, tyrosine kinases phosphorylate tyrosine residues in target proteins using adenosine triphosphate (ATP).

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XTalks

AUGUST 2, 2022

B cells require a specific protein for growth called BLyS (B-lymphocyte stimulator), which is implicated in the pathogenesis of SLE. The autoantibodies do not fight actual infection or bacteria, but rather the normal tissue in the body. When this behaviour is prolonged, it results in inflammation.

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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). How Does Rystiggo (Rozanolixizumab) Work?

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FDA Approval Antibody Protein Engineer 98

XTalks

DECEMBER 29, 2023

It targets delta-like ligand 3 (DLL3), a protein usually found inside normal cells but abnormally present on the surface of SCLC cells. New Drugs Approved for Small-Cell Lung Cancer Several drugs have received FDA approval for treating SCLC.

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Clinical Trials Clinical Trials FDA Approval Trials 119

XTalks

JULY 7, 2023

Pfizer’s alopecia JAK inhibitor Litfulo (ritlecitinib) has become its fourth US Food and Drug Administration (FDA) approved product in the past several weeks. Litfulo is entering the alopecia market to rival Eli Lilly’s Olumiant (baricitinib), which was approved as the first drug for alopecia areata a year ago.

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XTalks

FEBRUARY 8, 2024

Diabetes remains a critical global challenge, affecting millions of lives and commanding significant attention from the medical, life sciences and pharmaceutical sectors. Understanding the market dynamics of diabetes treatments becomes crucial for professionals across these industries. mL subcutaneous solution (2 mg/1.5

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XTalks

FEBRUARY 27, 2023

Chiesi Global Rare Diseases recently announced in a press release that Lamzede (velmanase alfa-tycv) received US Food and Drug Administration (FDA) approval for the treatment of non-neurological manifestations of alpha-mannosidosis in both adult and pediatric patients.

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XTalks

JUNE 28, 2023

DMD is caused by the absence of dystrophin, a protein that helps maintain the integrity of muscle cells. The FDA approval came after several delays and a narrow advisory committee vote of eight to six in favor of the gene therapy’s risk-benefit profile. It is injected into a patient’s muscle tissue.

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Drug Discovery World

APRIL 27, 2023

The report notes that the focus on science and pharma throughout the Covid-19 pandemic has resulted in the emergence of new locations as life science hubs and name checks Boston, Massachusetts and San Francisco, California as examples of centres with heightened investment appeal in the life sciences 1.

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XTalks

NOVEMBER 30, 2023

New FDA-Approved Treatments For HIV HIV treatment involves the administration of combined antiretroviral therapy (ART) to effectively suppress the viral load, maintain or enhance immune function and reduce the risk of opportunistic infections and cancers commonly associated with HIV. aiming to end the HIV epidemic by 2030.

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XTalks

NOVEMBER 6, 2023

Phathom Pharmaceuticals received two US Food and Drug Administration (FDA) approvals for its first-in-class heartburn drug Voquenza (vonoprazan) spaced just three days apart for heliobacter pylori ( H. Phathom said Voquenza will be available by December this year.

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XTalks

JANUARY 8, 2024

Initially receiving accelerated approval in December 2021 based on proteinuria as a surrogate marker, Tarpeyo has now achieved the status of being the first treatment for IgAN to receive full FDA approval predicated on evaluations of kidney function.

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XTalks

FEBRUARY 20, 2024

Consequently, this damage causes blood and protein leakage into the urine. Tarpeyo marks the first FDA-approved treatment aimed at mitigating the loss of kidney function in adults with primary IgA nephropathy. Moreover, the injury may progress to the scarring of nephrons, the filtering structures housing the glomeruli.

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XTalks

MAY 2, 2024

In 2023, the US Food and Drug Administration (FDA) approved a record-breaking 61 drugs, the most in history. Since January, the FDA has already signed off on more than a dozen novel drugs. The agency is reviewing applications for several highly anticipated drugs for approval in 2024.

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XTalks

MAY 26, 2023

Krystal Biotech’s Vyjuvek has been awarded US Food and Drug Administration (FDA) approval to make it the first topical gene therapy for the treatment of wounds in patients with the rare, often debilitating skin disease dystrophic epidermolysis bullosa (DEB).

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