Pharmaceutical Technology

JANUARY 22, 2023

Eli Lilly and Company and Boehringer Ingelheim have announced that the US Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for Jardiance (empagliflozin) tablets for chronic kidney disease (CKD) in adult patients.

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The FDA Law Blog

MARCH 18, 2025

Koblitz Integral to the careful balance Congress struck when passing the Hatch-Waxman Amendments, the patent term extension (PTE) is intended to restore patent life that was consumed during regulatory review of an FDA-regulated product. FDA has already been there , of course, with respect to 180-day exclusivity.)

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Pharmaceutical Technology

SEPTEMBER 27, 2023

The idiopathic pulmonary fibrosis (IPF) market is underserved with just two licensed pharmaceutical treatments approved by the FDA in 2014.

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Outsourcing Pharma

JUNE 7, 2021

The pharmacy company's Wegovy (semaglutide) is the first therapy designated for chronic weight management that the agency has granted approval since 2014.

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pharmaphorum

FEBRUARY 25, 2022

Eli Lilly and Boehringer Ingelheim’s blockbuster diabetes drug Jardiance (empagliflozin) has been granted approval by the US Food and Drug Administration (FDA) for a wider range of heart failure patients. . According to the FDA, heart disease impacts more than 650,000 people in the US each year. .

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STAT

NOVEMBER 17, 2023

They were approved under the FDA accelerated pathway in 2009 and 2014, respectively, for treating a rare form of blood cancer. The  The company’s final study plan was submitted to the FDA in 2022 and is expected to be completed  by 2030 , according to FDA briefing documents published earlier this week.

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STAT

OCTOBER 2, 2023

Dispirited, she left in 2014 to work for consulting firm Avalere to build a device recall database. Critical information, like unique device identifiers that help hospitals keep track of implants in patients, was often missing. Patients and doctors alike often knew very little about the safety record of their devices.

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STAT

NOVEMBER 8, 2023

But a large-scale clinical trial from Medtronic in 2014 called renal denervation’s efficacy into question, as it did not significantly reduce blood pressure compared to placebo treatments. The therapy, a simple procedure to reduce the blood pressure of millions of Americans , was once seen as a boon for cardiologists and device makers.

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pharmaphorum

AUGUST 16, 2022

AstraZeneca and Merck & Co’s PARP inhibitor Lynparza is already used to treat prostate cancer associated with a specific genetic mutation, but could see its use broadened if a new marketing application is approved by the FDA. The post FDA grants swift review to Lynparza in first-line prostate cancer appeared first on.

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Fierce Pharma

JULY 8, 2024

The traditional approvals follow initial accelerated approvals granted by the FDA in 2012 and the European Commission in 2014. It took many years, but Johnson & Johnson’s tuberculosis med Sirturo can finally claim full approvals in the U.S. and Europe following initial conditional nods. |

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The FDA Law Blog

AUGUST 4, 2023

Because anabolic steroids are also abused to enhance athletic performance and increase muscle strength, Congress has enacted three laws regulating anabolic steroids: the Anabolic Steroid Control Acts of 1990 and 2004, and the Designer Anabolic Steroid Control Act of 2014 (“DASCA”). DASCA became law, amending the CSA, on December 18, 2014.

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pharmaphorum

AUGUST 4, 2021

The HDAC inhibitor was given an accelerated approval by the FDA as a second-line PTCL therapy on the strength of overall response data, but a phase 3 study comparing Istodax to first-line chemotherapy showed no improvement on progression-free survival (PFS).

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pharmaphorum

JUNE 6, 2021

Novo Nordisk is celebrating the FDA approval of its GLP-1 agonist semaglutide as a treatment for obesity, which it believes has the potential to redefine the market for weight-loss medicines. . mg once-weekly formulation – which will be sold as Wegovy – is the first new medicine to be approved in the US for obesity since 2014.

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pharmaphorum

SEPTEMBER 30, 2022

Patient organisations have been celebrating the FDA approval yesterday of Amylyx’ amyotrophic lateral sclerosis (ALS) therapy Relyvrio, after not one but two advisory committee meetings that arrived at different conclusions about the drug. The post Relief for Amylyx as FDA clears controversial ALS drug Relyvrio appeared first on.

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pharmaphorum

JANUARY 17, 2022

After securing FDA approval for Wegovy last year, Novo Nordisk is strengthening its position in the obesity space through a collaboration with EraCal Therapeutics. Partnering with EraCal builds upon the success of Novo Nordisk’s Wegovy (semaglutide) chronic weight management drug, which was approved by the FDA in June 2021.

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Pharmafile

JANUARY 15, 2024

Merck, known as MSD outside of the US and Canada, has announced that the US Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab) in combination with chemoradiotherapy (CRT) for the treatment of FIGO (International Federation of Gynecology and Obstetrics) 2014 Stage III-IVA cervical cancer.

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The FDA Law Blog

OCTOBER 24, 2023

By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

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Labelling FDA Communication 64

STAT

JUNE 24, 2023

When Dana Lewis built her first artificial pancreas in 2014, she — and millions of other people with type 1 diabetes — didn’t have another option. But today, they have alternatives: Device manufacturers have caught up with their own, FDA-cleared closed-loop systems, and automated insulin delivery is becoming more common.

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PharmExec

JANUARY 15, 2024

The FDA issued the 39th overall approval for Keytruda (pembrolizumab), with the latest in combination with chemoradiation for the treatment of patients with FIGO 2014 stage III to IVA cervical cancer.

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Impact Pharmaceutical Services

MAY 4, 2022

The post Overview of FDA Expedited Development and Approval Programs for Serious Conditions appeared first on IMPACT Pharmaceutical Services, Inc.

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pharmaphorum

NOVEMBER 16, 2022

has announced that its platinum-resistant ovarian cancer drug ELAHERE (mirvetuximab soravtansine-gynx) has been granted FDA accelerated approval. RxDx Assay – Roche’s immunohistochemistry (IHC) companion diagnostic for identifying ovarian patients eligible for ELAHERE – has been contemporaneously approved by the FDA. ImmunoGen, Inc.

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pharmaphorum

FEBRUARY 23, 2021

The FDA is to begin a fast review of Incyte’s Jakafi (ruxolitinib) for patients with chronic graft-versus-host disease (GVHD), which cannot be treated with steroids. The post FDA to quickly review Incyte’s Jakafi in chronic GVHD appeared first on.

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The Checkup by Singlecare

NOVEMBER 30, 2023

Food and Drug Administration (FDA) used to rely heavily on a letter-based rating system for drug safety during pregnancy , with category A drugs being the safest to take, category X drugs being contraindicated because the risks outweigh the benefits, and category B, C, and D drugs varying in safety and adverse effects. Getting acupuncture.

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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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The Checkup by Singlecare

APRIL 14, 2024

Gabapentin is a prescription medication that is FDA-approved to treat epilepsy and neuropathic pain caused by shingles. A 2014 clinical trial of over 300 people with occasional insomnia found that gabapentin 250 milligrams (mg) and 500 mg lengthened the time people slept. This is because sleep stages allow the brain and body to rest.

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pharmaphorum

FEBRUARY 22, 2022

The FDA has approved expanded labelling for Abbott’s CardioMEMS HF System, an implantable sensor that provides an early warning of worsening heart failure, that could make it an option for more than a million more patients. The post FDA expands use of Abbott’s heart sensor with new approval appeared first on.

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European Pharmaceutical Review

APRIL 29, 2024

The US Food and Drug Administration (FDA) has approved the adeno-associated virus (AAV)-based gene therapy BEQVEZ (fidanacogene elaparvovec-dzkt) for certain adults with haemophilia B. Pfizer licensed BEQVEZ from Spark Therapeutics in December 2014.

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The FDA Law Blog

NOVEMBER 1, 2023

Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Javitt & Michael D. Shumsky & Philip Won & Adrienne R. Gaulkin & Jeffrey N.

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pharmaphorum

DECEMBER 14, 2022

Sodium oxybate — which in the late 1980s was marketed to bodybuilders and then became known as GHB and criminally used as a date rape drug — has been sold under the brand name Xyrem after gaining FDA approval in 2002. In 2020, the FDA-approved indication was expanded to include those patients who suffer from cataplexy.

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European Pharmaceutical Review

NOVEMBER 2, 2022

The clinic will develop pre-clinical studies into early and late phase clinical trials to identify US Food and Drug Administration (FDA)-approved advanced regenerative medicines. The organisation considers collaboration will advance scientific discovery, clinical advances and training.

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pharmaphorum

NOVEMBER 29, 2022

At NeoImmuneTech, a Biotech company founded in Maryland, US, in 2014, the answer to this question looks straightforward: “We believe in incremental progress”, says Dr Se Hwan Yang, president and chief executive officer of the company. Dr Se Hwan Yang, PhD, President and Chief Executive Officer, founded NeoImmuneTech in January 2014.

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pharmaphorum

SEPTEMBER 16, 2021

Just a few months ago, Amylyx was talking about having to complete another clinical trial before it could file for FDA approval of its drug for neurodegenerative disease amyotrophic lateral sclerosis (ALS). The post Amylyx preps filing for its ALS drug after FDA feedback appeared first on.

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pharmaphorum

JUNE 6, 2021

Novo Nordisk is celebrating the FDA approval of its GLP-1 agonist semaglutide as a treatment for obesity, which it believes has the potential to redefine the market for weight-loss medicines. . mg once-weekly formulation – which will be sold as Wegovy – is the first new medicine to be approved in the US for obesity since 2014.

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pharmaphorum

OCTOBER 3, 2022

Translarna has had European approval for usage since 2014 and has also been available under terms similar to the MAA to DMD patients in Scotland since 2021. Last week, Sarepta Therapeutics filed for accelerated FDA approval of its DMD gene therapy developed with Roche, SRP-9001 (delandistrogene moxeparvovec).

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pharmaphorum

MAY 25, 2021

With the ink barely dry on the FDA’s approval of Johnson & Johnson’s Rybrevant, its first bispecific antibody for cancer, the drugmaker is already showcasing others in its pipeline. .

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Pharmaceutical Technology

SEPTEMBER 5, 2022

The FDA has granted the drug an orphan drug designation, and Phase III trials with eplontersen were completed In June. Prior to this, the FDA had granted Enhertu regulatory approval for breast cancer treatment. Between 1 May 2016 and 31 May 2021, the FDA approved 207 drugs for cancer and malignant haematology.

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Impact Pharmaceutical Services

MAY 4, 2022

In May of 2014 and February of 2019 , the FDA released final Guidance for Industry outlining the Agency’s policies and procedures regarding expedited development and review programs for new drugs and biologics intended to treat serious or life-threatening conditions. May 4, 2022 | Nathaniel DiTommaso, MS, Regulatory Affairs Manager.

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