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

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

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

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

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 98

FDA Approval Drugs Sales Medicine 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

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 118

Sales FDA Approval 118

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

XTalks

APRIL 24, 2024

ImmunityBio’s Anktiva (N-803, or nogapendekin alfa inbakicept-pmln) along with the Bacillus Calmette-Guérin (BCG) vaccine has won US Food and Drug Administration (FDA) approval for the treatment of non-muscle invasive bladder cancer (NMIBC). Anktiva made pharma data intelligence firm Evaluate’s list of top ten drug launches this.

FDA Approval 52

FDA Approval Vaccination Vaccine Sales 52

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

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

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

FEBRUARY 8, 2024

The top 15 diabetes drugs in 2023, according to 2022 sales data, reflect the current state of diabetes management and hint at the evolving needs and trends within this critical area of healthcare. Read on to learn more about the top 15 diabetes drugs in 2023, based on 2022 sales statistics. mL subcutaneous solution (2 mg/1.5

Sales 52

Sales Insulin FDA Approval Drugs 52

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 120

FDA Approval Sales 120

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 75

Sales FDA Approval Drugs 75

Fierce Pharma

NOVEMBER 6, 2023

The drug launched after an FDA approval in May 2023.

Gene Therapy 106

Gene Therapy Sales Gene FDA Approval 106

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 120

FDA Approval Sales Protein Regulation 120

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

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

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 100

FDA Approval Sales 100

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 95

FDA Approval Sales Manufacturing Drugs 95

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

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

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

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

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 79

FDA Approval Sales Drugs 79

Fierce Pharma

FEBRUARY 28, 2024

After a busy 2023 marked by multiple drug approvals, UCB isn’t resting on its laurels. After an initial FDA approval came later than anticipated, UCB is looking to quickly grow Bimzelx. The company is eying four new indications and potential peak sales of 4 billion euros.

FDA Approval 95

FDA Approval Sales Drugs 95

Fierce Pharma

MARCH 19, 2024

Just a few days ago, Madrigal Pharmaceuticals made history by winning FDA approval for its metabolic dysfunction-associated steatohepatitis (MASH) med Rezdiffra. Madrigal's Rezdiffra became the first drug approved to treat metabolic dysfunction-associated steatohepatitis (MASH) just a few days ago.

Sales 52

Sales FDA Approval Drugs 52

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.

FDA Approval 52

FDA Approval Manufacturing Trials Clinical Trials 52

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

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.

FDA Approval 97

FDA Approval Antibody Immune Response Drugs 97

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

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

STAT News

DECEMBER 12, 2022

The Food and Drug Administration on Monday approved a second KRAS-blocking treatment for advanced lung cancer. However, hopes the drug might reach a large swath of patients — and grow into a commercial blockbuster for its maker Mirati Therapeutics — have dimmed in the wake of underwhelming clinical trial results.

FDA Approval 98

FDA Approval Sales Drugs Clinical Trials 98

Pharmaceutical Technology

JUNE 21, 2023

Ketarx will be marketed under the FDA-approved label of ketamine and in dosages that include 10mg/ml, 50mg/ml and 100mg/ml, with the option to boost the concentration and ready-to-administer applications. Ketamine is currently on the FDA’s drug shortage list. Ketamine is currently on the FDA’s drug shortage list.

FDA Approval 130

FDA Approval Sales Marketing Regulation 130

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 Marketing 98