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. In 2024, it registered sales of $4.9

FDA Approval 52

FDA Approval RNA Clinical Trials Clinical Trials 52

Bio Pharma Dive

MAY 23, 2023

But the drug’s sales potential isn’t clear, and a top competitor is close behind. The clearance of Ayvakit in indolent systemic mastocytosis is important to the biotech’s future.

FDA Approval 198

FDA Approval Drugs Sales 198

Pharmaceutical Technology

MAY 4, 2023

The US Food and Drug Administration (FDA) approved Kamada’s application to manufacture Cytogam (cytomegalovirus immune globulin intravenous [human]) at its facility located in Beit Kama, Israel. The regulatory approval represents the completion of the Cytogam technology transfer process from CSL Behring, its previous manufacturer.

FDA Approval 130

FDA Approval Manufacturing Production Protein 130

Bio Pharma Dive

NOVEMBER 30, 2022

The priority review voucher is one of two Bluebird received for winning FDA approvals of its gene therapies Zynteglo and Skysona, and its sale gives the company needed cash.

Gene Therapy 193

Gene Therapy FDA Approval Sales Gene 193

Bio Pharma Dive

JANUARY 18, 2024

The biotech will receive $500 million upon FDA approval of its rare disease drug acoramidis after selling 5% sales royalties to two investment firms.

FDA Approval 173

FDA Approval Drugs Sales 173

Bio Pharma Dive

AUGUST 29, 2024

Nipocalimab is one of several drugs J&J has forecast for multi-billion dollar sales. The company’s initial application is for its use in myasthenia gravis.

FDA Approval 133

FDA Approval Drugs Sales 133

Pharmaceutical Technology

APRIL 28, 2023

Novo Nordisk’s leading drug Ozempic (semaglutide) is forecast to demonstrate a sales growth of 23% in 2023. Ozempic’s forecast 2023 sales of $12.5bn consolidate its position as the dominant market leader, with projected sales in 2023 54% greater than closest competitor Trulicity (dulaglutide) by Eli Lilly, which anticipates sales of $8bn.

Sales 130

Sales Insulin Marketing FDA Approval 130

Pharmaceutical Technology

MAY 25, 2023

Yuflyma represents the company’s fifth biosimilar and second anti-TNF biosimilar to receive US FDA approval. The regulatory approval was based on a comprehensive data package of preclinical, analytical and clinical trials. It will be offered to patients in prefilled syringe and autoinjector administration options.

FDA Approval 130

FDA Approval Packaging Packaging Clinical Trials 130

Pharmaceutical Technology

JUNE 27, 2024

Ohtuvaye is expected to rake in $1.1bn in global sales from the market for COPD patients with moderate to severe exacerbations by 2029.

FDA Approval 130

FDA Approval Sales Marketing 130

Pharmaceutical Technology

MAY 19, 2023

The US Food and Drug Administration (FDA) has approved AbbVie’s Rinvoq (upadacitinib) for patients with Crohn’s disease who do not respond to TNF blockers, a common immune suppressant treatment for the condition. Data from two Phase III studies, U-EXCEED and U-EXCEL, involving 857 patients was used to support the approval.

FDA Approval 264

FDA Approval Dermatology Sales Clinical Trials 264

Pharmaceutical Technology

OCTOBER 23, 2023

The Remicade biosimilar is forecasted to have sales of $2.3bn by 2029 as a subcutaneous form is approved for the US market.

FDA Approval 130

FDA Approval Sales Marketing 130

Pharmaceutical Technology

SEPTEMBER 15, 2022

As a result of huge global sales of mRNA Covid-19 vaccines, the split in profits between Pfizer and BioNTech’s Comirnaty contributed towards revenues of $81.3bn and $22.4bn last year, respectively. Pfizer reaped $36.8bn from Comirnaty, the highest revenue generated from Covid-19 vaccine sales worldwide. YoY revenue growth.

Vaccination 272

Vaccination Vaccine Sales Generic Drugs 272

XTalks

APRIL 3, 2024

billion in sales in 2023, Ultomiris was approved in 2018 and generated $3 billion in revenue last year. Competitors in the PNH market include Novartis, which won approval for its factor B inhibitor Fabhalta (iptacopan), the first oral pill for PNH treatment, late last year.

FDA Approval 102

FDA Approval Sales Trials Development 102

XTalks

JANUARY 3, 2025

In this blog, we delve into the recent sales data to highlight the top three best-selling eye drugs in 2023. Lets take a closer look at Eylea, Vabysmo and Lucentis the ophthalmology drugs that led the pack in recent sales figures. Related: Top 30 Drugs to Watch in 2024: Insights from 2023 Sales Data 1. billion, down from $1.50

Sales 85

Sales FDA Approval Drugs Medicine 85

Pharmaceutical Technology

MAY 10, 2023

While the government said that Gilead secured its PrEP approvals only after CDC’s research on the topic, the company stated that there already were published materials on the potential use of antiretroviral therapies as PrEP prior to this. billion in global sales in 2029, while Truvada estimates amount to $30 million.

Drugs 264

Drugs FDA Approval Containment Licensing 264

pharmaphorum

SEPTEMBER 16, 2021

Takeda has had a run of bad luck with its Wave1 pipeline of new drug candidates of late, but can now celebrate a vestry after getting FDA approval for first-in-class lung cancer therapy Exkivity. The post Takeda gets a win for its Wave1 pipeline, as Exkivity nabs FDA approval appeared first on.

FDA Approval 105

FDA Approval Sales Clinical Trials Clinical Trials 105

XTalks

JUNE 26, 2023

Surmodics will manufacture and supply the device and realize revenue from product sales to Abbott as well as a share of profits from Abbott’s third-party sales. SurVeil’s FDA approval was based on 24 months of data from the pivotal, head-to-head TRANSCEND clinical trial that compared it against Medtronic’s IN.PACT.

FDA Approval 96

FDA Approval Drugs Sales In-Vitro 96

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. percent of US sales revenue from Niktimvo.

FDA Approval 99

FDA Approval Drugs Gene Trials 99

Pharmaceutical Technology

APRIL 11, 2023

Zydus, which currently has 360 approvals, has filed abbreviated new drug applications for more than 440 drugs since 2003-04. The company stated that azithromycin tablets generated annual sales of $20m in the US.

FDA Approval 130

FDA Approval Drugs Immune Response Manufacturing 130

Fierce Pharma

FEBRUARY 5, 2024

Less than two months after the FDA approved the combination treatment of Astellas and Pfizer’s Padcev and Merck’s Keytruda in first-line bladder cancer, the Japanese company has

Sales 114

Sales FDA Approval 114

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 28, 2021

Merck has scored US Food and Drug Administration (FDA) approval for its next-generation pneumonia vaccine Vaxneuvance that covers 15 different strains of the pneumococcal bacteria that causes the infection. billion in sales in 2020 and has been outselling Merck’s previous shot, Pneumovax 23, by almost five to one.

FDA Approval 89

FDA Approval Vaccination Vaccine Immune Response 89

XTalks

DECEMBER 18, 2023

Merck received its second US Food and Drug Administration (FDA) approval for its cancer pill Welireg (belzutifan). The oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor was first approved in August 2021 for von Hippel-Lindau (VHL), a rare hereditary disease that causes tumor growth in different organs, particularly the kidney.

FDA Approval 98

FDA Approval Drugs Sales Medicine 98

Fierce Pharma

NOVEMBER 6, 2023

The drug launched after an FDA approval in May 2023.

Gene Therapy 95

Gene Therapy Sales Gene FDA Approval 95

Fierce Pharma

DECEMBER 15, 2023

Since Merck secured approval for kidney cancer pill and blockbuster hopeful Welireg (belzutifan) in August of 2021, sales have grown slowly but surely. Since Merck secured approval for kidney cancer pill and blockbuster hopeful Welireg (belzutifan) in August of 2021, sales have grown slowly but surely.

FDA Approval 112

FDA Approval Sales 112

XTalks

JUNE 21, 2024

In 2023, Vaxneuvance, which was approved in 2021, netted $665 million in sales. Last year, sales of Pfizer’s pneumococcal vaccines reached $6.4 However, Vaxneuvance has contributed to slowing down Prevnar 20’s sales growth from 20 percent in 2022 to two percent last year.

FDA Approval 108

FDA Approval Vaccination Vaccine Life Science 108

pharmaphorum

JULY 10, 2024

After short but worrying delay, Arcutis gets FDA approval for flagship drug Zoryve in atopic dermatitis, which could further unlock sales growth

FDA Approval 116

FDA Approval Sales Drugs 116

XTalks

DECEMBER 12, 2023

After receiving US Food and Drug Administration (FDA) approval for Fabhalta (iptacopan) last week for the treatment of the rare blood disorder paroxysmal nocturnal hemoglobinuria (PNH), Novartis presented trial data yesterday showing the drug’s promise in another indication.

FDA Approval 95

FDA Approval Bacteria Trials Protein 95

pharmaphorum

OCTOBER 30, 2024

Novartis says FDA approval for frontline use of its leukaemia drug Scemblix will boost the number of eligible patients four-fold, as it hunts blockbuster sales

FDA Approval 115

FDA Approval Sales Drugs 115

XTalks

JANUARY 29, 2025

Related: Eli Lillys Kisunla (donanemab) Gets Full FDA Approval After Initial Rejection, Gears Up to Take on Leqembi Leqembi was first approved in 2023 as a monoclonal antibody targeting amyloid-beta protofibrils and plaques proteins that cause brain cell damage and cognitive decline in Alzheimers disease.

FDA Approval 66

FDA Approval Antibody Sales Protein 66

pharmaphorum

MARCH 21, 2025

J&J's Tremfya gets a much-anticipated FDA approval for Crohn's disease, which the company thinks will be key to a renewed phase of sales growth.

FDA Approval 59

FDA Approval Sales 59

XTalks

OCTOBER 25, 2022

Related: AstraZeneca’s Enhertu Gets FDA Approved as First Therapy for HER2-Low Breast Cancer. Imjudo’s approval was based on results from the HIMALAYA Phase III trial , which showed that patients treated with the Imjudo and Imfinzi combination experienced a 22 percent reduction in the risk of death versus sorafenib.

FDA Approval 98

FDA Approval Trials Drugs Immune Response 98

pharmaphorum

MARCH 21, 2025

Novartis' oral complement inhibitor Fabhalta has become the first approved treatment for rare kidney disease C3G as it chases a $3bn sales target

FDA Approval 82

FDA Approval Sales 82

pharmaphorum

AUGUST 4, 2021

Bristol-Myers Squibb’s HDAC inhibitor Istodax has been on the US market for a decade as a treatment for peripheral T-cell lymphoma (PTCL), but will now be withdrawn from sale after a failed phase 3 trial. The post Failed trial nixes another FDA approval, this time for BMS’ Istodax appeared first on.

FDA Approval 98

FDA Approval Trials Sales Drugs 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. The drug generated domestic sales of $200.4 The drug generated domestic sales of $200.4

FDA Approval 105

FDA Approval Genetics Gene Therapy Gene 105

Pharmaceutical Technology

NOVEMBER 11, 2022

For the quarter ending on 30 September 2022, product sales were reported at $10.59bn from $9.7bn in Q3 last year, indicating a growth of 9%. In October, the US Food and Drug Administration (FDA) approved the company’s Imjudo (tremelimumab) plus Imfinzi (durvalumab) for treating adults with unresectable hepatocellular carcinoma.

FDA Approval 242

FDA Approval Clinical Trials Clinical Trials Sales 242

BioPharma Reporter

APRIL 25, 2024

Back in 2014, AstraZeneca and Merck were the first to receive FDA approval for their PARP inhibitor Lynparza (olaparib) for use in breast cancer gene (BRCA)-mutated metastatic ovarian cancer patients.

FDA Approval 98

FDA Approval Sales Gene Marketing 98