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.

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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

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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.

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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.

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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.

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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 It issued a draft guidance in 2017 which was subsequently revised in 2019.

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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.

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FDA 98

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.

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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.

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FDA 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.

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FDA Labelling 90

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.

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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.

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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?

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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.

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FDA Chemotherapy Documentation 90

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.

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FDA Labelling 94

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.

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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.

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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

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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.

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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.

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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.

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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.

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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.

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FDA 105

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.

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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.

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Pharmacy Times

MARCH 12, 2025

Eculizumab, a humanized monoclonal antibody, was first approved for adults with generalized myasthenia gravis in 2017.

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FDA 73

STAT

SEPTEMBER 19, 2023

Pear’s reSET was the first such app cleared by the FDA in 2017. Pear, which filed for bankruptcy earlier this year , was one of the leading companies marketing prescription digital therapeutics, or Food and Drug Administration-cleared apps designed to treat disease. Continue to STAT+ to read the full story…

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STAT

APRIL 23, 2024

So judging the FDA’s accelerated approval program without assessing its full impact on overall survival presents a very slanted story. Overall survival is usually considered the gold standard in oncology because people with cancer generally want to take medications that can help them live longer.

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Pharmaceutical Technology

FEBRUARY 8, 2023

On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases.

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FDA Documentation Communication 105

STAT

JUNE 17, 2024

From 2017 to 2020, the company sold nearly 8,000 devices with the fake component. Under CEO Laura Perryman’s leadership, the company warped the design of their devices to earn more reimbursement money from insurers, resulting in unnecessary plastic parts that allowed doctors to claim around $18,000 more than they previously could.

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Insurance FDA 131

Fierce Pharma

JUNE 20, 2024

BioNTech and MediLink's HER3 ADC has been put on a partial clinical hold by the FDA. BioNTech and MediLink's HER3 ADC has been put on a partial clinical hold by the FDA. drug authorities met at the FDA's headquarters for the first time since 2017. Senior officials from China and U.S. And more.

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FDA 52

pharmaphorum

OCTOBER 19, 2020

Tecartus was cleared by the US FDA in the summer, and was the first CAR-T from Kite to launch without direct competition, as its first therapy Yescarta (axicabtagene ciloleucel) is going head-to-head in the market with Novartis’ rival Kymriah (tisagenlecleucel). billion acquisition of Kite in 2017.

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Chemotherapy FDA 124

The FDA Law Blog

DECEMBER 11, 2023

Mullen — With comments due on the proposed LDT rule last week, FDA wasted no time updating the Unified Agenda to indicate that a final rule may be published in April ( here ). Under the Administrative Procedure Act, FDA is obligated to address major substantive issues when – and not so much if – it publishes a final rule.

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FDA Research Laboratories Documentation 69

pharmaphorum

MAY 5, 2021

A medicine based on MDMA – the active ingredient in recreational drug ecstasy – is on the cusp of FDA approval as a treatment for post-traumatic stress disorder (PTSD), according to the organisation developing it. . A second is underway in 100 subjects and if positive could result in a green light for the therapy in 2023.

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The FDA Law Blog

SEPTEMBER 16, 2024

Schwartz — FDA recently published a Federal Register (FR) Notice [ Docket No. FDA-2024-N-3945 ] announcing the publication of a draft strategy document, for public comment, outlining specific actions FDA plans to take to facilitate the use of innovative manufacturing technologies.

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Documentation FDA Communication 59

STAT

FEBRUARY 9, 2023

The $88 billion in total deal value last year, involving 75 biopharma tie-ups of at least $100 million, was the lowest since 2017, according to Ernst & Young. The acquisitions could help the companies add new sales to aging line-ups and suggest this year could be a busy one for industry dealmaking.

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pharmaphorum

MARCH 2, 2021

Merck & Co has voluntarily withdrawn its Keytruda immunotherapy from a lung cancer niche in the US, amid a crackdown by the FDA on drugs approved without the required post-marketing data. Merck & Co said it had withdrawn the indication after consultation with the FDA and is working to complete the process over the coming weeks.

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