Fierce Pharma

APRIL 23, 2024

Dating to a 2019 clinical hold of a phase 3 trial, getting its gene therapy ra | Dating to a 2019 clinical hold, getting its gene therapy pz-cel across the FDA finish line has been a challenge for troubled Abeona Therapeutics. Now the wait continues as the FDA has rejected the treatment due to CMC issues.

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Gene Therapy Gene Trials 89

Fierce Pharma

DECEMBER 13, 2022

Arcutis' topical cream goes 2 for 2 in pivotal eczema trials to clear path to FDA. Tue, 12/13/2022 - 06:07.

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Trials 96

Pharmaceutical Technology

JANUARY 8, 2024

The FDA has granted approval for Ligand Pharmaceuticals’ Zelsuvmi (berdazimer topical gel, 10.3%) for molluscum contagiosum.

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pharmaphorum

AUGUST 31, 2022

Futura Medical’s development of a topical treatment for erectile dysfunction (ED) is approaching the finish line in the US, as the UK biotech reports confirmatory phase 3 data ahead of an FDA filing later this month. ” The post Futura eyes FDA filing as topical ED drug passes phase 3 test appeared first on.

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Drugs FDA Approval Production Marketing 52

Pharmaceutical Commerce

DECEMBER 18, 2023

Arcutis Biotherapeutics said Zoryve foam will be widely available via key wholesaler and dermatology pharmacy channels by the end of January 2024.

FDA Approval 52

FDA Approval Dermatology Pharmacy 52

Pharmaceutical Commerce

DECEMBER 20, 2023

Filsuvez is indicated to treat wounds associated with junctional epidermolysis bullosa and dystrophic epidermolysis bullosa in patients aged 6 months and older.

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Fierce Pharma

JANUARY 11, 2024

Dermavant’s topical cream Vtama, already on the market for plaque psoriasis as a steroid-free treatment, is compiling impressive data in pursuit of an FDA approval in atopic dermatitis (AD).

FDA Approval 124

FDA Approval Marketing Trials 124

BioTech 365

SEPTEMBER 21, 2021

FDA Approval of Opzelura™ (ruxolitinib) Cream, a Topical JAK Inhibitor, for the Treatment of Atopic Dermatitis (AD) Incyte Announces U.S. FDA Approval of Opzelura™ (ruxolitinib) Cream, a Topical JAK Inhibitor, for the Treatment of Atopic Dermatitis (AD) … Continue reading → Incyte Announces U.S.

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FDA Approval 40

Pharmaceutical Technology

JULY 19, 2022

The US Food and Drug Administration (FDA) has granted approval for Incyte’s Opzelura (ruxolitinib) cream 1.5% as a topical treatment of nonsegmental vitiligo in adults and paediatric patients aged 12 years and above. Opzelura is a topical formulation of a Janus kinase (JAK) inhibitor.

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pharmaphorum

MARCH 10, 2024

The FDA has said it will seek the advice of independent advisors before it concludes its review of Eli Lilly’s amyloid-targeting Alzheimer’s disease therapy donanemab, delaying its review of the drug.

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Drugs Regulation 124

BioSpace

DECEMBER 3, 2023

This week, the FDA could approve the first CRISPR-edited therapy in the U.S., while two other companies await decisions on topical drugs.

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Drugs 115

Pharmaceutical Technology

JUNE 9, 2023

Biopharmaceutical company Novaliq has received approval from the US Food and Drug Administration (FDA) for VEVYE (cyclosporine ophthalmic solution) 0.1% CyclASol is topical anti-inflammatory and immunomodulating ophthalmic drug solution containing 0.1% to treat the signs and symptoms of dry eye disease.

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FDA Approval Bioavailability Containment Drugs 246

The Pharma Data

OCTOBER 25, 2020

Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for cyclosporine topical ophthalmic emulsion, 0.1% The FDA has set June 26, 2021 as the Prescription Drug User Fee Act (PDUFA) goal date. ” The NDA submission for cyclosporine topical ophthalmic emulsion, 0.1%

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Drugs Production Marketing Development 52

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.

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FDA Approval Branding Development Drugs 75

CTTI (Clinical Trials Transformation Initiative)

JANUARY 9, 2024

Food and Drug Administration (FDA) and the Clinical Trials Transformation Initiative (CTTI) announced eight newly selected representatives for the Patient Engagement Collaborative (PEC). The FDA listens closely to PEC members to integrate different perspectives into meaningful patient engagement and communication opportunities.”

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Clinical Trials Clinical Trials Trials Regulation 124

Pharmaceutical Technology

APRIL 19, 2023

The US Food and Drug Administration (FDA) has accepted Arcutis Biotherapeutics ’ new drug application (NDA) for roflumilast foam 0.3% The NDA submission to the FDA was based on positive data obtained from the Phase II and pivotal Phase III trials of roflumilast foam. in patients with seborrheic dermatitis.

Dermatology 130

Dermatology Trials Drugs Regulation 130

FDA Law Blog

MARCH 10, 2024

Last August the Food and Drug Administration (“FDA”)/Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule cannabis from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III.

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Regulation Drugs Production Research 64

Pharmaceutical Technology

DECEMBER 5, 2022

Incyte could also grant a potential licence to CMS for other topical formulations of ruxolitinib to treat ailments, such as vitiligo and atopic dermatitis, in the future, for patients in mainland China, Hong Kong, Macau, Taiwan and some Southeast Asia nations.

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Dermatology FDA Approval Sales Production 130

Pharmaceutical Technology

JUNE 8, 2023

The US Food Drug Administration (FDA) has granted orphan drug designation to DTx Pharma’s investigational DTx-1252 for the treatment of Charcot-Marie-Tooth disease Type 1A (CMT1A). Topic sponsors are not involved in the creation of editorial content. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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Pharmaceutical Technology

MAY 5, 2023

The US Food and Drug Administration (FDA) has accepted Optinose’s supplemental new drug application (sNDA) for Xhance (fluticasone propionate) to treat chronic rhinosinusitis, which is now under review. The drug-device combination product Xhance nasal spray combines a nasal anti-inflammatory drug with an exhalation delivery system (EDS).

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Pharmaceutical Technology

SEPTEMBER 12, 2022

The US Food and Drug Administration (FDA) has granted approval for Bristol Myers Squibb ’s (BMS) Sotyktu (deucravacitinib) to treat adult patients with moderate-to-severe plaque psoriasis. The post US FDA grants approval for BMS’ Sotyktu to treat plaque psoriasis appeared first on Pharmaceutical Technology.

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FDA Approval Clinical Trials Clinical Trials Trials 246

XTalks

AUGUST 3, 2022

In this episode, Ayesha discussed the FDA approval of Azurity Pharmaceutical’s Zonisade (zonisamide oral suspension) as an adjunct therapy for the treatment of seizures in adults and pediatric patients 16 years of age and older with epilepsy. The drug is the first FDA approved oral suspension form of zonisamide.

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Life Science FDA Approval Drugs Development 52

Pharmaceutical Technology

MAY 22, 2023

The US Food and Drug Administration (FDA) has granted approval for Krystal Biotech’s Vyjuvek (beremagene geperpavec-svdt) to treat dystrophic epidermolysis bullosa (DEB) in patients aged six months and above. Vyjuvek is a non-invasive, topical, re-dosable gene therapy that delivers functional human COL7A1 gene copies to offer wound healing.

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FDA Approval Gene Therapy Genetic Disease Gene 130

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. Gilead markets both Truvada and its successor Descovy.

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FDA Approval Drugs Containment Licensing 264

Fierce Pharma

NOVEMBER 6, 2023

The drug launched after an FDA approval in May 2023.

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Gene Therapy Sales Gene FDA Approval 118

FDA Law Blog

NOVEMBER 28, 2023

Gibbs — Shortly before the Thanksgiving holiday, FDA announced with no fanfare that it would be holding a Molecular and Clinical Genetics Panel meeting this Wednesday November 29. Thus, it’s not entirely surprising that FDA would seek input from a panel on this topic. By Allyson B. Mullen & Jeffrey N.

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In-Vitro Genetics Regulation Development 64

XTalks

FEBRUARY 8, 2022

For the US Food and Drug Administration (FDA), the new year brings along a new set of food safety tasks to tackle. The FDA anticipates it will publish many of these documents by the beginning of next year. Related: Baby Food Safety Act of 2021: Why Didn’t FDA Regulate Heavy Metals Sooner?

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Cosmetics Regulation Genome Genomics 97

Rethinking Clinical Trials

JULY 6, 2023

The Food and Drug Administration (FDA) issued a draft guidance in May 2023 that provided guidance about the conduct of decentralized clinical trials. Additional considerations are needed for the data management plan, monitoring plan, safety plan, task log, and case report forms in the FDA draft guidance.

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Trials Clinical Trials Clinical Trials Licensing 130

XTalks

MAY 31, 2023

In this episode, Ayesha talked about the FDA approval of the first topical gene therapy for the treatment of a rare skin condition. Krystal Biotech’s Vyjuvek is a topical gene therapy that has been approved for the treatment of wounds in patients with the rare, often debilitating skin disease dystrophic epidermolysis bullosa (DEB).

Gene Therapy 52

Gene Therapy Gene FDA Approval Life Science 52

Camargo

OCTOBER 14, 2021

FDA Discusses Focus Areas for PDUFA VII During Public Meeting. Following the August publication of the proposed PDUFA VII commitment letter negotiated with industry, the FDA held its corresponding required public meeting on September 28. Improved predictability in Human Factors and User-Related Risk reviews.

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STAT News

APRIL 18, 2023

Over the past five years, digital mental health has risen from a niche topic to a global health priority. Two companies that came to embody this potential were Mindstrong for smartphone monitoring of mental health and Pear Therapeutics for FDA-approved apps and digital interventions. billion evaluation.

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FDA Approval Regulation Research 111

Pharmaceutical Technology

SEPTEMBER 22, 2022

Avrobio has received rare pediatric disease designation from the US Food and Drug Administration (FDA) for its investigational gene therapy, AVR-RD-04, designed to treat cystinosis. The FDA's rare pediatric disease designation and Voucher Program aid the development of new drugs and biologics to prevent and treat rare paediatric ailments.

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Gene Therapy Gene Protein Clinical Trials 147

XTalks

AUGUST 2, 2022

Biopharmaceutical company Incyte received approval from the US Food and Drug Administration (FDA) for Opzelura (ruxolitinib) cream 1.5 percent for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older. Opzelura’s vitiligo FDA approval is the second it has received in just under a year.

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FDA Approval Clinical Trials Clinical Trials Scientist 52

Eye on FDA

AUGUST 17, 2022

Periodically I write a posting to look back at what FDA is talking about to get some perspective. Soon, we may have a new dominating topic in Monkeypox. So let’s take a look: Volume – Let’s look first at the numbers of releases issued by FDA for the first six months of the year.

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STAT News

DECEMBER 1, 2022

The first FDA-approved fecal microbiome drug. We cover all these topics and more on this week’s episode of “The Readout LOUD,” STAT’s biotech podcast. We also discuss the FDA approval of a microbiome drug for the treatment of a bowel disorder and the potential for a big acquisition of Horizon Therapeutics.

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FDA Approval Drugs Research 94

XTalks

MAY 31, 2022

This cream by Dermavant is the first steroid-free topical medication in its class. Current treatment methods of psoriasis include topical therapy (e.g., Topical applications have been studied profoundly and were found to have limitations, like in their duration and extent of use. Psoriasis is a well-recognized skin disease.

FDA Approval 98

FDA Approval Clinical Trials Clinical Trials Trials 98

Pharmaceutical Technology

MAY 24, 2023

The AMP programme is a public-private partnership between a number of biopharmaceutical and life sciences companies, the US Food and Drug Administration (FDA) and the National Institutes of Health (NIH), along with non-profit and other organisations. Topic sponsors are not involved in the creation of editorial content.

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