XTalks

NOVEMBER 28, 2023

This liquid formulation of metronidazole is the sole FDA-approved liquid option, offering a groundbreaking prescribing alternative for patients encountering difficulties in swallowing or facing taste-related obstacles. With a 24-month shelf life and no need for refrigeration, Likmez provides a convenient option for patients.

FDA Approval 103

FDA Approval Bacteria DNA Drugs 103

STAT News

JULY 15, 2022

Then came the next challenge: getting Andy a prescription for tecovirimat (brand name TPOXX), an FDA-approved drug developed and stockpiled by the U.S. It took seven days for him to get a test and, when the results came back from the New York City Health Department five days later, he learned he tested positive for monkeypox.

FDA Approval 105

FDA Approval Drugs Doctors Doctor 105

XTalks

OCTOBER 22, 2021

In July 2021, the agency approved the first interchangeable biosimilar product, Semglee (insulin glargine-yfgn) for the treatment of diabetes. The FDA approved the supplemental Biologics License Application (sBLA) for Cyltezo as the first interchangeable biosimilar with Humira.

FDA Approval 98

FDA Approval Production Insulin Antibody 98

BioSpace

NOVEMBER 8, 2023

The oral targeted therapy, now sold under the brand name Fruzaqla, is approved for adults with metastatic colorectal cancer who have received certain previous treatments for the disease.

FDA Approval 100

FDA Approval Branding 100

Pharmacy Checkers

FEBRUARY 14, 2020

Many readers complained that it just wasn’t cutting it compared to the brand name version. a generic with the exact same formulation as the brand) of Wellbutrin XL available. Just switch back to the brand!” In fact, many people reported that when they were switched to the Teva generic Wellbutrin XL, their depression returned.

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Branding FDA Approval Pharmacy Bioequivalency 62

BioSpace

OCTOBER 23, 2023

The regulator has approved the first-ever subcutaneous version of infliximab, an IgG1 monoclonal antibody, commonly sold by Johnson & Johnson under the brand name Remicade.

FDA Approval 98

FDA Approval Branding Antibody Regulation 98

BioSpace

OCTOBER 18, 2023

Following a delay and an initial rejection, UCB’s IL-17A/IL-17F blocker bimekizumab was approved for moderate-to-severe plaque psoriasis, which will now be marketed with the brand name Bimzelx.

FDA Approval 96

FDA Approval Branding Marketing 96

Fierce Pharma

JULY 25, 2024

Three months after bagging FDA approval, Pfizer’s hemophilia B gene therapy has been cleared to expand its reach across the pond. | the drug is approved under the brand name Beqvez. The company's first gene therapy will debut in Europe as Durveqtix. In the U.S.,

Gene Therapy 107

Gene Therapy Gene FDA Approval Branding 107

World of DTC Marketing

OCTOBER 21, 2021

It focused on four medications, according to the researchers: atezolizumab, which is sold under the brand name Tecentriq; durvalumab, or Drazalex; nivolumab, or Opdivo; and pembrolizumab, or Keytruda. Between 2011 and 2018, cumulative spending on 44 FDA-approved oral targeted therapy drugs was $3.5

Clinical Trials 234

Clinical Trials Clinical Trials FDA Approval Trials 234

pharmaphorum

JUNE 27, 2024

Verona Pharma has claimed FDA approval for its chronic obstructive pulmonary disease (COPD) drug ensifentrine, which has been tipped as a future blockbuster.The first-in-class dual phosphodiesterase (PDE) 3/4 inhibitor – now given the somewhat tongue-twisting brand name of Ohtuvayre – is the first inhaled product with a novel mechanism of action available (..)

FDA Approval 114

FDA Approval Drugs Marketing Branding 114

Outsourcing Pharma

DECEMBER 18, 2023

The oral treatment belzutifan, developed by MSD (known as Merck in the US) and branded as Welireg, has received the green light from the US Food and Drug Administration (FDA) for the treatment of an advanced form of renal cell carcinoma (RCC).

FDA Approval 92

FDA Approval Branding Development Drugs 92

BioSpace

OCTOBER 17, 2023

The complement inhibitor won the FDA’s approval for the treatment of generalized myasthenia gravis, a rare autoimmune disease. The therapy will be sold under the brand name Zilbrysq.

FDA Approval 87

FDA Approval Branding 87

Outsourcing Pharma

DECEMBER 19, 2023

The US Food and Drug Administration (FDA) has approved a topical foam developed by Arcutis Biotherapeutics and branded as Zoryve for the skin condition seborrheic dermatitis in people aged nine years and up.

FDA Approval 81

FDA Approval Branding Development Drugs 81

Intouch Solutions

OCTOBER 26, 2021

you wouldn’t trust tax information on a recipe website), branded properties (i.e., brands should be seen as the authoritative sources for their own information), and being recommended by other experts. Similarly, pharma brands are their own entities, so the organizations behind these sites are never in question to Google or users.

Branding 97

Branding FDA Approval Doctors Doctor 97

pharmaphorum

JANUARY 21, 2021

Bayer and Merck & Co’s heart failure drug vericiguat has been approved by the FDA under the brand name Verquvo, in an increasingly competitive market. Entresto (sacubitril+valsartan) was FDA-approved in patients with reduced ejection fraction five years ago.

FDA Approval 72

FDA Approval Drugs Trials Doctor 72

World of DTC Marketing

JUNE 6, 2021

The headlines read “FDA approves obesity drug that helped people cut weight 15%” But buyer beware. The drug already exists at a lower dose as an anti-diabetic medication under the brand names Ozempic and Rybelsus made by the same pharmaceutical company, Novo Nordisk.

Drugs 318

Drugs Cosmetics Production FDA Approval 318

Pharmaceutical Commerce

NOVEMBER 1, 2023

The branded form of secukinumab is currently the only FDA-approved fully human biologic that directly inhibits interleukin-17A.

FDA Approval 52

FDA Approval Branding 52

BioSpace

MARCH 28, 2021

The FDA approved ide-cel, which will be marketed under the brand name Abecma.

FDA Approval 85

FDA Approval Branding Marketing 85

World of DTC Marketing

MARCH 10, 2022

AbbVie, Humira’s manufacturer, kicked off 2020 with a price increase in excess of 7 percent on its mega-blockbuster brand-name treatment. AbbVie filed 55% of Imbruvica’s patent applications after FDA approval, the report said”. Sales of Humira earned AbbVie $20.7 So how do people who work for AbbVie feel?

FDA Approval 205

FDA Approval Drugs Branding Sales 205

BioSpace

SEPTEMBER 28, 2023

After several rejections over 20-plus years, Fabre-Kramer Pharmaceuticals has secured the FDA’s approval for its major depressive disorder drug gepirone hydrochloride, now marketed under the brand name Exxua.

FDA Approval 79

FDA Approval Drugs Branding Marketing 79

XTalks

JANUARY 9, 2023

Register for this free webinar to learn about the value of real-world data as a critical business tool to guide brand strategy and find the right patients for best outcomes. Live and On-Demand: Tuesday, February 7, 2023, at 12pm JST/Japan (8:30am IST/India). The CAPELLA Clinical Trial Evaluated the Antiviral Activity of Sunlenca.

FDA Approval 98

FDA Approval Drugs In-Vitro Clinical Trials 98

XTalks

JUNE 29, 2021

Prescription digital medicine company Akili Interactive is set to launch a digital campaign for its FDA-approved video game for the treatment of attention deficit hyperactivity disorder (ADHD). The video game is called EndeavorRx and is the first and only FDA-backed therapy delivered through a video game experience.

FDA Approval 81

FDA Approval Pharmacy Marketing Medicine 81

XTalks

SEPTEMBER 10, 2024

Amneal Pharmaceuticals and Shilpa Medicare have announced US Food and Drug Administration (FDA) approval of Boruzu, a ready-to-use formulation of bortezomib for subcutaneous or intravenous (IV) administration.

FDA Approval 105

FDA Approval Branding Drugs Pharmacy 105

STAT News

MARCH 30, 2023

Food and Drug Administration approved selling Narcan — the brand name for naloxone — without a prescription, setting the overdose-reversing drug on course to become the first opioid treatment drug to be sold over the counter, the Associated Press writes. We hope you have a smashing day and, of course, do keep in touch.

FDA Approval 98

FDA Approval Vaccination Vaccine Branding 98

Pharma Marketing Network

MARCH 6, 2025

Social media advertising now plays a crucial role in reaching healthcare professionals (HCPs) and patients , allowing pharma brands to engage, educate, and build trust like never before. So, how can pharma brands maximize engagement while staying compliant ? Why Pharma Brands Need Social Media Ads Instant Reach With over 4.9

Compliance 52

Compliance Branding Marketing Regulation 52

pharmaphorum

AUGUST 17, 2020

The FDA has approved Roche’s satralizumab for the rare autoimmune disorder Neuromyelitis Optica Spectrum Disorder (NMOSD), under the brand name Enspryng. The post Roche takes on Alexion as FDA approves satralizumab in NMOSD appeared first on.

FDA Approval 66

FDA Approval Antibody Branding Trials 66

Pharmaceutical Technology

JULY 29, 2022

There is no medication specifically approved for ASD-associated agitation and other drugs approved for irritability might be used to manage the agitation episodes, Veenstra-VanderWeele says. Eli Lilly markets olanzapine under the brand name Zyprexa. Nasal spray for acute treatment.

FDA Approval 264

FDA Approval Branding Trials Drugs 264

Pharmaceutical Technology

MAY 16, 2023

Lecanemab, the brand name of which is LEQEMBI in the US, is indicated to treat mild cognitive impairment caused due to AD and mild AD in people with confirmed presence of amyloid pathology in the brain. In January 2023, the US Food and Drug Administration (FDA) approved lecanemab under the accelerated approval pathway to treat AD.

Antibody 130

Antibody FDA Approval Branding Regulation 130

pharmaphorum

JUNE 3, 2021

The FDA approval of Alkermes’ new antipsychotic drug Lybalvi couldn’t have gone any better for the company, but it could still face a big challenge positioning the new drug in the highly genericised market. The post After FDA approval, Alkermes plans soft launch for antipsychotic Lybalvi appeared first on.

FDA Approval 52

FDA Approval Marketing Branding Generic Drugs 52

XTalks

DECEMBER 14, 2022

In this week’s Xtalks Life Science podcast episode, Ayesha and the team spoke with the co-founders and co-CEOs of Amylyx, Joshua Cohen and Justin Klee, and Amylyx’s General Manager of Canada Chris Aiello, about the recent FDA approval of the company’s ALS drug Relyvrio.

Life Science 52

Life Science FDA Approval Drugs Branding 52

BioTech 365

DECEMBER 17, 2021

FDA Approval of DARTISLA ODT (Glycopyrrolate) Orally Disintegrating Tablets Edenbridge Pharmaceuticals Announces U.S. FDA Approval of DARTISLA ODT (Glycopyrrolate) Orally Disintegrating Tablets – Edenbridge’s first 505(b)(2) branded drug to be granted FDA approval – DARTISLA ODT … Continue reading →

FDA Approval 40

FDA Approval Branding Drugs 40

XTalks

MARCH 19, 2025

Over the years, Xtalks has built the industrys preeminent life science podcast, helping brands in pharma, biotech, healthcare and medical devices showcase their expertise to key decision-makers through valuable, industry-leading content. Dont miss out on this opportunity to elevate your brand and stay top-of-mind in a competitive market.

Life Science 52

Life Science Branding Clinical Trials Clinical Trials 52

XTalks

JUNE 17, 2024

“We are thrilled with the FDA’s approval of Letybo. This is a huge achievement for Hugel as we focus on becoming a top aesthetics brand in the US,” said James Hartman, president of Hugel America in the news release. “As

FDA Approval 52

FDA Approval Marketing Botox Clinical Trials 52

Pharmaceutical Technology

MARCH 24, 2023

Amgen’s (US) Amjevita (adalimumab) is the first Humira biosimilar, launched in February 2023, and seven other FDA-approved biosimilars are expected to arrive on the US market later this year. In addition, two more Humira biosimilars are currently under FDA review and both are anticipated to launch in 2023.

FDA Approval 147

FDA Approval Marketing Manufacturing Sales 147

Pharmaceutical Technology

FEBRUARY 10, 2023

On November 22, 2022, the FDA approved CSL Behring’s Hemgenix (etranacogene dezaparvovec), the first gene therapy treatment for hemophilia B, with a staggering manufacturer price of $3.5 million, according to GlobalData’s Price Intelligence (POLI), making it the most expensive drug in the world.

Gene Therapy 263

Gene Therapy Marketing Gene Drugs 263

World of DTC Marketing

JUNE 2, 2021

One of our tests, one of the most read emails, had a subject line of “new label information for prescribing just FDA approved.” Your physician audience should be segmented by parameters that are important to the success of your brand. Your email needs to have a simple, eye-catching subject line.

Doctors 180

Doctors Doctor Sales Marketing 180

XTalks

AUGUST 2, 2022

The US Food and Drug Administration (FDA) has granted approval to Azurity Pharmaceuticals’ liquid version of its epilepsy drug zonisamide (100 mg/5 mL; brand name Zonisade) as an adjunct therapy for the treatment of partial seizures in adults and pediatric patients 16 years of age and older with epilepsy.

FDA Approval 52

FDA Approval Clinical Trials Clinical Trials Drugs 52