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

pharmaphorum

JANUARY 26, 2022

Immunocore has secured a piece of biotech industry history, becoming the first company to get an FDA approval for a cancer therapeutic based on T cell receptor (TCR) technology. The post Immunocore claims first-ever FDA approval for TCR cancer therapy appeared first on.

FDA Approval 124

FDA Approval Sales Protein Trials 124

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.

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Vaccination Vaccine Sales Generic Drugs 272

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

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

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

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

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

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

JUNE 3, 2024

First approved in 2011, Eylea’s market value was estimated to be $8.79 As one of Regeneron’s best-selling drugs, US sales of Eylea were approximately $5.89 First approved in 2022 and winning a subsequent approval in 2023 for macular edema following RVO, Vabysmo exceeded sales expectations earning about $2.7

FDA Approval 98

FDA Approval Sales Clinical Trials Clinical Trials 98

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

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

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

XTalks

OCTOBER 4, 2022

Rolvedon is the first long-acting granulocyte colony-stimulating factor (GCSF) to be FDA-approved in over 20 years that is not a biosimilar. Our commercial team is in place and ready to engage key stakeholders immediately,” said Erin Miller, Senior Vice President, Sales and Marketing of Spectrum Pharmaceuticals.

FDA Approval 98

FDA Approval Clinical Trials Clinical Trials Trials 98

pharmaphorum

JANUARY 16, 2025

Eli Lilly picks up a second FDA approval for IL-23 inhibitor Omvoh in Crohn's disease, but will it kickstart sales growth

FDA Approval 104

FDA Approval Sales 104

pharmaphorum

NOVEMBER 24, 2020

Genentech is in talks with the FDA to develop Xofluza for acute uncomplicated influenza in otherwise healthy children (one to 12 years of age) and for the prevention of influenza in the same age group who have been exposed to influenza. Xofluza is currently not approved for use in this population.

FDA Approval 105

FDA Approval Medicine Licensing Licensing 105

pharmaphorum

SEPTEMBER 20, 2024

J&J's target of $5bn in sales for Rybrevant has moved a step closer, after an FDA approval for second-line treatment of EGFR+ NSCLC

FDA Approval 105

FDA Approval Sales 105

XTalks

JULY 14, 2022

Related: Vtama (tapinarof) Cream Gains FDA Approval for the Treatment of Plaque Psoriasis in Adults. million in net sales last year, which is a year-over-year growth of 39 percent. There were no new safety signals reported in the trial. The drug has proven to be quite profitable for Horizon as it hit a record of $565.5

FDA Approval 105

FDA Approval Antibody Trials Drugs 105

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

FDA Approval 98

FDA Approval Drugs Clinical Trials Clinical Trials 98

pharmaphorum

DECEMBER 4, 2020

Amivantamab is also the first drug to be filed specifically for patients with exon 20 mutations, who don’t tend to respond well to current therapies including EGFR inhibitors, and as a result picked up a breakthrough designation from the FDA for this use.

FDA Approval 93

FDA Approval Sales Antibody Drugs 93