pharmaphorum

JUNE 20, 2025

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FDA 71

FDA Pharmaceutical Companies Pharmaceutical Companies 71

Drug Topics

JUNE 25, 2025

from 2017 to 2020. Children today are less active than they used to be—and they’re also facing an increased amount of stress.” In recent history, childhood obesity statistics have indeed been alarming, with the US prevalence of youth-related obesity at 19.7%

Compounding 315

Compounding Insurance Coverage Insurance Specialty Pharmacies 315

STAT

OCTOBER 31, 2024

Between 2017 and 2021, regulators in the U.S. Of 104 reports of supply chain issues with dozens of drugs, meaningful shortages were 40% less likely to occur in Canada than in the U.S., a new study found, and the difference was largely attributed to the approach taken by the Canadian government to the problem.

FDA 129

FDA 129

Fierce Pharma

FEBRUARY 13, 2024

It’s the approval Ipsen has been waiting for since buying up Onivyde in 2017. It’s the approval Ipsen has been waiting for since buying up Onivyde in 2017. The FDA has approved Onivyde as part of a combination dubbed Nalirifox to treat patients with newly diagnosed metastatic pancreatic cancer.

FDA 122

FDA 122

Fierce Pharma

SEPTEMBER 13, 2024

When Roche's Genentech gained approval for Ocrevus in 2017, the first-in- | The day after Roche gained an FDA approval for its subcutaneous version of cancer drug Tecentriq, the company also scored with a U.S. nod for its under-the-skin formulation of mega-blockbuster multiple sclerosis drug Ocrevus.

FDA 120

FDA 120

STAT

MARCH 5, 2024

The first continuous glucose monitor was approved by the FDA in 2017. The sensor will pair with a smartphone app, which will provide blood glucose measurements every 15 minutes. Dexcom has not yet released the price of the device.

FDA 142

FDA 142

pharmaphorum

APRIL 8, 2024

Less than half of the cancer therapies given accelerated approval by the FDA in 2013 to 2017 showed a clinical benefit in a confirmatory trial within the next five years

FDA 110

FDA 110

Fierce Pharma

APRIL 8, 2024

One hallmark of the FDA's accelerated approval pathway is the requirement that medicines prove their benefits in confirmatory trials. Many cancer meds approved under the FDA's accelerated approval pathway from 2013 to 2017 didn't improve overall survival after more than five years of follow-up research, the study found.

FDA 117

FDA 117

Pharmacy Times

APRIL 11, 2024

Benralizumab was previously approved by the FDA in 2017 as an add-on maintenance therapy for patients 12 years and older.

FDA 111

FDA 111

STAT

MARCH 26, 2024

By comparison, the FDA inspected 976 clinical study sites in 2017. And the FDA was unable to complete about 30% of one type of common inspection within the requested time frames from fiscal year 2018 through July 2023.

FDA 116

FDA Hospitals 116

PhRMA

MAY 8, 2023

 After ibrutinib was initially approved in 2017 for adult patients with cGVHD who have tried and failed on at least one previous medicine, the U.S. Food and Drug Administration (FDA) issued a BPCA written request to the sponsor for studies in pediatric cGVHD patients. In

FDA 261

FDA 261

Pharmacy Times

JULY 24, 2024

In April 2017, the drug was approved to treat the slow loss of the ability to walk for symptomatic patients aged 3 and older who had Batten disease.

FDA 122

FDA 122

pharmaphorum

SEPTEMBER 28, 2022

The US FDA’s Center for Devices and Radiological Health (CDRH) dropped a bevy of new digital health guidances and reports today and yesterday, providing some long-awaited clarity and peeks into the agency’s future plans. . The push started yesterday with the 31-page key findings report from the FDA Pre-Certification Program pilot.

FDA 135

FDA Documentation 135

The FDA Law Blog

DECEMBER 15, 2022

By Riëtte van Laack — On December 7, 2022, FDA announced the availability of the final guidance regarding the enforcement policy for homeopathic drug products. This concludes FDA’s reevaluation of the regulation of homeopathic drugs which it started in 2015. It issued a draft guidance in 2017 which was subsequently revised in 2019.

FDA 98

FDA Labelling 98

Fierce Pharma

AUGUST 22, 2023

With a new FDA approval to rival Teva's Austedo, Neurocrine Biosciences’ Ingrezza is debuting in a treatment area with hundreds of millions of dollars of revenue potential. | The FDA approved Ingrezza capsules to treat adult with chorea associated with Huntington’s disease.

FDA 98

FDA Labelling 98

STAT

AUGUST 16, 2023

In a July 19 letter , the FDA warned Light Sciences Oncology about its failure to post study results about a prostate treatment to the database, ClinicalTrials.gov. Its trial was completed in 2017, but the company missed a deadline to seek a reporting extension. After receiving the FDA letter, Light Sciences posted results on Aug.

FDA 96

FDA 96

STAT

JANUARY 15, 2025

billion in revenue by dispensing medicines to treat cancer, HIV, heart disease, and other serious illnesses at prices that exceeded their estimated acquisition costs between 2017 and 2022.  STAT later revealed that Biogen executives recruited an FDA official to help secure the approval. The

Insurance 91

Insurance FDA 91

Fierce Pharma

NOVEMBER 20, 2023

Thanks to a new FDA approval, patients with ultra-rare desmoid tumors now have an FDA-approved treatment. Patients with ultra-rare desmoid tumors now have an FDA-approved treatment, thanks to a drug made by SpringWorks Therapeutics, which spun out of Pfizer in 2017 with a portfolio of rare disease candidates.

FDA 89

FDA 89

Fierce Pharma

JULY 5, 2023

the same can’t be said for the cost of an FDA priority review voucher. Since 2017, the company has sold off three PRVs—getting less in return for each successive sale. While the price of just about everything has increased over the last six years in the U.S., Just ask Sarepta Therapeutics. | Just ask Sarepta Therapeutics.

FDA 104

FDA 104

The FDA Law Blog

OCTOBER 27, 2024

a homeopathic drug company, filed a complaint on behalf of the homeopathic drug industry against FDA in the District Court for the District of Columbia (“D.D.C.”). This lawsuit presents an interesting reading of the statute at issue, one that is diametrically opposed to that of FDA. It’s a dessert topping; no, it’s a floor wax.

FDA 100

FDA 100

Fierce Pharma

MARCH 20, 2024

After Johnson & Johnson last year changed its mind on its 2017 purchase of ap | Idorsia's Tryvio is the first oral anti-hypertensive therapy that uses a new therapeutic mechanism in nearly 40 years, suggesting the dawn of "a new era of endothelin research," the company said.

FDA 120

FDA 120

pharmaphorum

NOVEMBER 1, 2021

Novartis has claimed FDA approval for one of its ‘wild card’ drugs – Scemblix – a first-in-class STAMP inhibitor for patients with previously-treated chronic myeloid leukaemia (CML). The post Novartis’ ‘wild card’ drug Scemblix gets FDA nod for leukaemia appeared first on.

FDA 115

FDA Labelling 115

STAT

JANUARY 10, 2023

As biotechs pursue more cutting-edge cell and gene therapies, the FDA has been issuing more suspensions than it had, according to a review of FDA data on clinical holds. The agency halted clinical trials for experimental drugs an average of 664 times each year from 2017 to 2021, up from 557 each of the previous five years.

FDA 96

FDA 96

The Checkup by Singlecare

JANUARY 19, 2024

Food and Drug Administration (FDA) has granted the state of Florida the authority to import certain prescription drugs from Canada—an important measure to counteract soaring prescription costs. After delays that took a lawsuit to resolve, the FDA authorized the program on Jan. In a landmark decision, the U.S. an outlier?

FDA 105

FDA Dosage Insurance 105

The Checkup by Singlecare

NOVEMBER 11, 2024

As a brand-name prescription drug, Lexapro is FDA -approved to treat major depressive disorder and anxiety disorders. Although trazodone is FDA -approved for depression, it’s primarily known for its off-label use as a sleep aid due to its sedative effects.

Labelling 94

Labelling FDA 94

The FDA Law Blog

JULY 7, 2025

By Véronique Li, Senior Medical Device Regulation Expert — In late June, FDA published five Federal Register notices that caught our eye, particularly for the dates the classifications were first applicable. Each notice listed the action as “Final amendment; final order” rather than “Final order.”

FDA 52

FDA Documentation 52

pharmaphorum

APRIL 27, 2021

FDA advisors will scrutinise three cancer immunotherapies granted conditional approvals at a three-day meeting this week, to see if they should stay on the market. . Briefing documents published by the FDA ahead of the meeting suggest that discussion will focus on ongoing trials that may serve as alternative confirmatory studies.

FDA 90

FDA Chemotherapy Documentation 90

pharmaphorum

JULY 29, 2021

Generic drugmaker Mylan has become the first company to secure FDA approval for a biosimilar product that is considered completely interchangeable with the reference product – namely Sanofi’s once-daily insulin Lantus. The post FDA okays Mylan insulin drug as first ‘interchangeable’ biosimilar appeared first on.

FDA 98

FDA 98

pharmaphorum

FEBRUARY 8, 2021

Bristol-Myers Squibb finally has FDA approval for its CAR-T therapy liso-cel, which has been cleared by the US regulator as Breyanzi for certain forms of large B-cell lymphoma. DLBCL is the most common type of NHL in adults, accounting for around a third of the 77,000 new cases diagnosed in the US, according to the FDA.

FDA 111

FDA Chemotherapy Labelling 111

STAT

APRIL 7, 2024

In some cases, failure to show clinical benefit didn’t stop the FDA from converting accelerated approvals into full approvals, and the authors note the agency’s conversion decisions have increasingly been based on less stringent evidence of a drug’s benefits. In 2013, it took an average of 9.9

FDA 142

FDA 142

pharmaphorum

OCTOBER 31, 2021

The FDA has approved the first and so far only pharmacological treatment for presbyopia, a sight condition that typically starts in middle age and involves difficulty in focusing on near objects. Its candidate UNR844 (lipoic acid/choline ester chloride) – acquired with Encore Vision in 2017 – works by restoring the elasticity of the lens.

FDA 105

FDA 105

pharmaphorum

DECEMBER 29, 2021

Sanofi and Regeneron have another challenger to their big-selling drug Dupixent for atopic dermatitis, now that the FDA has approved Leo Pharma’s rival antibody tralokinumab. The post Leo puts target on Dupixent in US as FDA clears tralokinumab appeared first on.

FDA 111

FDA Labelling 111

STAT

MAY 19, 2023

The company received the first FDA clearance for a standalone digital therapeutic in 2017 for reSET, a product that used cognitive behavioral therapy to treat substance use disorder. It was followed by clearances for reSET-O,  an app for opioid use disorder, and Somryst, for insomnia.

FDA 137

FDA 137

The FDA Law Blog

MAY 13, 2024

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). FDA recognizes the potential of RWE to support regulatory submissions of medical devices and to inform benefit-risk analysis of such products, while assuring patients have timely access to devices.

FDA 111

FDA Medical Records Documentation 111

pharmaphorum

JUNE 17, 2025

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Pharmaceutical Companies 89

Pharmaceutical Companies Pharmaceutical Companies FDA 89

pharmaphorum

JUNE 26, 2025

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Pharmaceutical Companies 83

Pharmaceutical Companies Pharmaceutical Companies FDA 83

pharmaphorum

JUNE 12, 2025

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Health and Personal Care Stores 59

Health and Personal Care Stores Pharmaceutical Companies Pharmaceutical Companies Insurance Coverage 59