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.

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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.

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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).

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STAT News

APRIL 7, 2023

Danco Laboratories — which makes a branded version of the drug, called Mifeprex — said late Friday evening that it would seek a stay and immediately appeal the ruling. The ruling will go into effect in seven days if a stay is not granted by an appeals court or by the Supreme Court. Read the rest…

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pharmaphorum

AUGUST 21, 2020

It’s mission accomplished for Novartis after the FDA approved ofatumumab for multiple sclerosis, completing a project where the former cancer drug has been repurposed. The FDA approved ofatumumab under the brand name Kesimpta for people living with relapsing forms of multiple sclerosis.

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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.

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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.

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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.

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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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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.

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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 →

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Pharmaceutical Commerce

JANUARY 31, 2024

As a result, time to treatment for the brand Gilead product is expected to increase from 16 to 14 days.

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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.

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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.

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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.

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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.

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FDA Law Blog

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. Brand drugs, generic drugs, and medical devices alike have all been the target of state failure-to-warn litigation; in a recent case, OTC acetaminophen is the target.

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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.

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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.

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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.

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pharmaphorum

AUGUST 2, 2021

AstraZeneca has completed the resurrection of its anifrolumab drug for systemic lupus erythematosus (SLE) after claiming FDA approval for the drug as an add-on therapy for adults with the autoimmune disease. The post FDA approves AZ’s anifromulab, ending 10-year lupus drug drought appeared first on.

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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.

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The Pharma Data

MAY 19, 2023

ABBOTT RECEIVES FDA APPROVAL FOR TACTIFLEX™ ABLATION CATHETER FOR TREATMENT OF ABNORMAL HEART RHYTHM Abbott (NYSE: ABT) today announced that the U.S. About Abbott Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our 115,000 colleagues serve people in more than 160 countries.

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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.

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The Pharma Data

JANUARY 21, 2021

Cabotegravir is a ViiV product marketed as Cabenuva, and rilpivirine is a Janssen product with a brand name Edurant. Today’s FDA approval of Cabenuva represents a shift in the way HIV is treated, offering people living with HIV a completely new approach to care,” said Lynn Baxter, Head of North America, ViiV Healthcare. “Not

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BioSpace

MARCH 28, 2021

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

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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.

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BioSpace

OCTOBER 21, 2021

?The CDC supported the FDA's approval of mixing and matching vaccines, where eligible populations can take a booster shot from another brand different from their initial series.

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The Pharma Data

AUGUST 15, 2021

Food and Drug Administration (FDA) has approved TICOVAC (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older. 1 TICOVAC is the only FDA-approved vaccine to help protect U.S. Following today’s FDA approval, the U.S.

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XTalks

JANUARY 25, 2021

Cabenuva was actually expected to win FDA approval towards the end of 2019; however, manufacturing issues garnered rejection from the FDA at the time. Since then, Cabenuva received its first global approval in Canada in March 2020, followed by authorization in the EU in December under two separate brand names.

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Pharmacy Checkers

JULY 11, 2019

means thousands or even millions of patients have no option beyond buying branded drugs that can cost thousands of dollars per month.” Out of 40 generic medications that were approved from 2017 to 2018, PharmacyChecker research found the following: 42.5% (17) are not available in the U.S. is cheaper than the U.S. generic versions.

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The Pharma Data

DECEMBER 15, 2020

FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp. Food and Drug Administration (FDA) has approved Klisyri (tirbanibulin) for the topical treatment of actinic keratosis (AK) on the face or scalp. The FDA approval of Klisyri is a significant milestone for Athenex.

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The Pharma Data

MARCH 15, 2022

To further facilitate generic drug development, and to assist the generic pharmaceutical industry in this process, the FDA publishes product-specific guidances (PSGs) describing the agency’s current thinking and expectations on how to develop generic drug products that are therapeutically equivalent to their brand name counterparts.

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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.

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The Pharma Data

DECEMBER 17, 2020

There will be a brand-new treatment for actinic keratosis on the market next year, with Tuesday’s FDA approval of Athenix’s Klisyri® (tirbanibulin). This will be the first branded proprietary product for Athenex, which will be launched in the U.S. The FDA approval of Klisyri is a significant milestone for Athenex.

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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

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The Pharma Data

MARCH 31, 2023

The approval may also affect the status of other brand-name naloxone nasal spray products of 4 mg or less, but determinations will be made on a case-by-case basis and the FDA may contact other firms as needed. director of the FDA’s Center for Drug Evaluation and Research.

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