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

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

JULY 25, 2023

Emergent BioSolutions, a multinational specialty biopharmaceutical company headquartered in Gaithersburg, Maryland, has achieved a significant milestone with the approval of its Cyfendus (Anthrax Vaccine Adsorbed, Adjuvanted) vaccine by the US Food and Drug Administration (FDA). anthracis exposure. anthracis.

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XTalks

AUGUST 18, 2023

Iveric Bio, a company of Astellas, has secured recent approval from the US Food and Drug Administration (FDA) for its innovative drug, Izervay (avacincaptad pegol intravitreal solution). Another New Treatment for Geographic Atrophy There is one other FDA-approved drug for geographic atrophy on the market.

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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 The FDA approved 2.5

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XTalks

JANUARY 26, 2023

The US Food and Drug Administration (FDA) recently granted approval for the Bruton tyrosine kinase inhibitor (BTKi) Brukinsa (zanubrutinib) based on the results from two Phase III clinical trials. Brukinsa is now approved to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

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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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XTalks

OCTOBER 4, 2022

The US Food and Drug Administration (FDA) has approved Spectrum Pharmaceuticals’ Rolvedon (eflapegrastim-xnst) injection. Myelosuppressive drugs kill cancer cells and normal cells in the bone marrow, which diminishes the amount of normal red blood cells, white blood cells and platelets in the bone marrow and blood.

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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

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

DECEMBER 13, 2023

The US Food and Drug Administration (FDA) has approved the first gene therapies for the treatment of sickle cell disease, approving two on the same day. The landmark approvals were awarded to bluebird bio’s Lyfgenia (lovo-cel) and Vertex Pharmaceuticals and CRISPR Therapeutics’ jointly developed Casgevy (exa-cel).

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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

MARCH 10, 2023

But with Skyclarys (omaveloxolone), the first and only drug to treat Friedreich’s ataxia in patients aged 16 years and older, Reata Pharmaceuticals has developed a new treatment option to improve neurological function. This US Food and Drug Administration (FDA)-approved drug was also awarded a rare pediatric disease priority review voucher.

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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. Dupixent is approved for patients 12 years of age or older (weighing over 40 kg) at a dose of 300 mg per week. On Friday, Regeneron Pharmaceuticals, Inc.

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XTalks

JUNE 2, 2021

The US Food and Drug Administration (FDA) has granted approval to Amgen’s KRAS inhibitor Lumakras (sotorasib) as the first treatment for non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation. The sotorasib approval is therefore a major breakthrough in the world of cancer and targeted therapies.

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XTalks

JANUARY 5, 2021

Both drug discovery and drug repurposing to manage and treat the disease will also continue as experts learn more about the virology and epidemiology of the novel SARS-CoV-2 coronavirus that wreaked havoc in 2020. These include monoclonal antibody drugs, which are attractive therapeutic agents owing to their targeted specificity.

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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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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

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

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. Read on to learn more about the top 15 diabetes drugs in 2023, based on 2022 sales statistics. In 2023, Ozempic was the 13 th best-selling drug globally.

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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

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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XTalks

SEPTEMBER 16, 2022

Last week, Bristol Myers Squibb (BMS) announced that their therapy Sotyktu (deucravacitinib) was approved by the US Food and Drug Administration (FDA) as a first-line treatment for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. We welcome this new treatment option.”.

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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

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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XTalks

DECEMBER 29, 2023

Amgen recently reported that the US Food and Drug Administration (FDA) has given priority review status to its drug candidate, tarlatamab, intended for the treatment of small-cell lung cancer (SCLC). New Drugs Approved for Small-Cell Lung Cancer Several drugs have received FDA approval for treating SCLC.

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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

AUGUST 2, 2022

On July 27, 2022, GSK announced that the US Food and Drug Administration (FDA) has approved Benlysta (belimumab) as an intravenous treatment for lupus and active lupus nephritis (LN) in children between the ages of 5 and 17 who are receiving standard therapy. When this behaviour is prolonged, it results in inflammation.

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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

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

FEBRUARY 24, 2023

The US Food and Drug Administration (FDA) granted accelerated approval to Genentech’s Lunsumio (mosunetuzumab) for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have undergone two or more lines of systemic therapy. New treatment options are critically needed for FL.

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XTalks

SEPTEMBER 17, 2021

The ALS Association is pushing for rapid FDA approval of Amylyx Pharmaceuticals Inc.’s s candidate drug AMX0035 (sodium phenylbutyrate/taurursodiol) for the treatment of amyotrophic lateral sclerosis, or ALS. This time, the group is backing a drug that they believe will greatly benefit ALS patients.

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XTalks

MAY 24, 2022

Antiretroviral drugs for HIV are classified as integrase strand transfer inhibitors (INSTIs), nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), cytochrome P4503A (CYP3A) inhibitors, protease inhibitors (PIs) and others. Lenacapavir: A Treatment Candidate for HIV.

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XTalks

AUGUST 17, 2020

Duchenne muscular dystrophy (DMD) patients with a mutation in exon 53 of the dystrophin gene now have a second approved treatment option, and Xtalks spoke with Sharon Hesterlee, PhD, Muscular Dystrophy Association executive vice president and chief research officer, to learn more.

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XTalks

JUNE 28, 2023

Gene therapies for Duchenne muscular dystrophy (DMD) have been an area of intense research and Sarepta’s Elevidys is now the first one to be approved by the US Food and Drug Administration (FDA). DMD is caused by the absence of dystrophin, a protein that helps maintain the integrity of muscle cells.

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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

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. The drug was actually initially approved in May 2022 for H.

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