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 195

FDA Approval Drugs Sales 195

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 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

MARCH 30, 2023

Biogen/Eisai’s newly approved drug, Leqembi (lecanemab), gained FDA approval in January 2023 for the treatment of Alzheimer’s disease. The breakthrough drug is predicted to be a blockbuster, generating total forecast sales of $12.9bn between 2023 and 2028.

Sales 147

Sales Drugs Antibody FDA Approval 147

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

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

Bio Pharma Dive

AUGUST 19, 2021

The expanded clearance in heart failure with reduced ejection fraction is expected to boost sales of the drug, called Jardiance.

FDA Approval 258

FDA Approval Drugs Sales 258

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 111

FDA Approval Sales Drugs 111

Pharmaceutical Technology

MARCH 30, 2023

Biogen/Eisai’s newly approved drug, Leqembi (lecanemab), gained FDA approval in January 2023 for the treatment of Alzheimer’s disease. The breakthrough drug is predicted to be a blockbuster, generating total forecast sales of $12.9bn between 2023 and 2028.

Sales 130

Sales Drugs Antibody FDA Approval 130

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 169

FDA Approval Drugs Sales 169

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 92

FDA Approval Drugs Sales Medicine 92

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 78

FDA Approval Sales Trials Development 78

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 117

Sales FDA Approval 117

XTalks

NOVEMBER 7, 2024

Maraoui said the company’s dermatology-focused sales force is “now preparing for a successful launch and to establish Emrosi as a new standard of care in the treatment of rosacea.” Journey Medical plans to make Emrosi available by early 2025 through dermatology clinics and pharmacies across the US.

FDA Approval 91

FDA Approval Dermatology Bacteria Clinical Trials 91

XTalks

DECEMBER 19, 2023

As we approach the end of 2023, a retrospective look at the statistics from 2022 reveals the top 20 drugs dominating retail sales. In this article, we will explore the factors contributing to the success of the top 20 drugs in 2023 by retail sales from the prior year. 1) Comirnaty (COVID-19 Vaccine, mRNA) Sales in 2022: $37.81

Sales 64

Sales FDA Approval Drugs Vaccine 64

Fierce Pharma

JULY 27, 2023

Securing FDA approvals last year for three drugs that each have peak sales potential of $4 billion bodes well for the long-term future of Bristol Myers Squibb. And it's projecting overall sales decline for 2023. Bristol Myers Squibb is entering a dark stage.

Sales 82

Sales FDA Approval Drugs 82

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 73

FDA Approval Drugs Sales In-Vitro 73

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 189

Gene Therapy FDA Approval Sales Gene 189

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 119

FDA Approval Sales 119

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

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 92

FDA Approval Genetics Gene Therapy Gene 92

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 115

FDA Approval Sales Drugs 115

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 69

FDA Approval Bacteria Trials Protein 69

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 100

FDA Approval Sales 100

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

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 85

FDA Approval Vaccination Vaccine Life Science 85

Fierce Pharma

NOVEMBER 6, 2023

The drug launched after an FDA approval in May 2023.

Gene Therapy 110

Gene Therapy Sales Gene FDA Approval 110

Fierce Pharma

JUNE 20, 2024

AbbVie’s fast-growing Humira successor Skyrizi is already on a roll with skyrocketing sales. Now, its fourth approved disease area is ulcerative colitis. Since its original nod in 2019, AbbVie's IL-23 inhibitor has added several new uses over the years.

FDA Approval 81

FDA Approval Sales 81

BioSpace

FEBRUARY 7, 2023

The biopharma company reported sales of $2.24 billion in the second quarter for the cystic fibrosis treatment, beating analysts’ estimate, after it won FDA approval in children ages two to five in April.

Sales 52

Sales FDA Approval 52

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

Outsourcing Pharma

JUNE 27, 2024

The US Food and Drug Administration (FDA) has approved Verona Pharmaâs Ohtuvayre (ensifentrine), marking a significant milestone in the treatment of chronic obstructive pulmonary disease (COPD).

FDA Approval 52

FDA Approval Sales Drugs Clinical Development 52

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 94

FDA Approval Trials Drugs Immune Response 94

NPR Health - Shots

MARCH 29, 2023

The FDA approved Narcan for sale without a prescription. The opioid overdose reversal drug would be available at pharmacies and convenience stores nationally, increasing access as opioid deaths climb.

Sales 54

Sales FDA Approval Pharmacy Drugs 54

BioTech 365

DECEMBER 15, 2021

Eagle Pharmaceuticals Receives FDA Approval for Vasopressin Eagle Pharmaceuticals Receives FDA Approval for Vasopressin — Company is first to file an ANDA referencing Vasostrict®, which had total U.S. sales of $786 million in 2020 — WOODCLIFF LAKE, N.J.–(BUSINESS

FDA Approval 52

FDA Approval Sales 52

BioSpace

SEPTEMBER 27, 2023

The companies on Wednesday secured the regulator’s approval for their eye drop Ryzvumi for the reversal of pharmacologically-induced mydriasis, as Viatris looks to add $1 billion in sales by 2028.

FDA Approval 81

FDA Approval Sales 81

Fierce Pharma

NOVEMBER 2, 2023

Ever since Novo Nordisk won FDA approval for its GLP-1 weight-loss med Wegovy more than 2 years ago, analysts and investors have been keeping a close eye on the blockbuster drug launch.

FDA Approval 101

FDA Approval Sales Manufacturing Drugs 101

Fierce Pharma

AUGUST 2, 2023

The convenience of shorter infusion time is a big selling point for TG Therapeutics’ newly FDA-approved multiple sclerosis drug Briumvi. | The convenience of shorter infusion time is a big selling point for TG Therapeutics’ newly FDA-approved multiple sclerosis drug Briumvi.

FDA Approval 86

FDA Approval Sales Drugs 86