STAT

MAY 20, 2024

After his spinal cord injury in 2014, Sherown Campbell worked hard to regain as much bodily function as he could. Once a dedicated athlete, Campbell had to learn the new limits of his body. One of them, jarringly, was his body’s inability to sweat.

FDA 140

FDA 140

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.

FDA 52

FDA 52

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.

FDA 105

FDA 105

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.

FDA 103

FDA Documentation 103

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By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

Labelling 64

Labelling FDA Communication 64

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.

FDA 105

FDA 105

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.

FDA 113

FDA 113

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.

Insurance 122

Insurance FDA Hospitals 122

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. .

FDA 101

FDA 101

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.

FDA 52

FDA 52

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.

FDA 98

FDA 98

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.

FDA 98

FDA Specialty Pharmacies Labelling Hospitals 98

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.

FDA 111

FDA Labelling 111

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.

FDA 116

FDA Hospitals 116

PharmaShots

JUNE 21, 2023

Shots: The US FDA has approved Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) as additions to diet and exercise to improve blood sugar control in children aged ≥10yrs. Jardiance & Synjardy was approved in the US in 2014 & 2015, respectively. with inadequately controlled T2D.

FDA 40

FDA 40

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).

FDA 98

FDA Chemotherapy Labelling 98

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.

FDA 98

FDA 98

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.

FDA 95

FDA Dosage 95

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.

Dosage 97

Dosage Labelling FDA 97

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.

FDA 66

FDA Labelling 66

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.

FDA 64

FDA Labelling 64

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.

FDA 52

FDA 52

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.

FDA 114

FDA Immunization 114

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.

FDA 73

FDA 73

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.

FDA 123

FDA Pharmaceutical Companies Pharmaceutical Companies 123

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.

FDA 52

FDA Documentation Communication 52

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.

FDA 52

FDA Dosage 52

pharmaphorum

JANUARY 10, 2022

Swiss biotech Idorsia has claimed FDA approval for its first product – insomnia treatment Quviviq – setting up a market challenge to class rivals from Merck & Co and Eisai. The post Dream result for Idorsia as FDA clears its insomnia drug appeared first on.

FDA 52

FDA Labelling 52

The FDA Law Blog

FEBRUARY 29, 2024

156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug.

FDA 59

FDA Documentation 59

The FDA Law Blog

JANUARY 7, 2024

A review of FDA’s Postmarketing Requirements and Commitments database reveals that one of the most common reasons FDA requires postmarketing studies is to assess the impact of a drug on maternal and fetal outcomes when taken by pregnant women. For post-approval pregnancy studies, it most certainly does.

FDA 59

FDA Documentation Vaccines 59

PharmaShots

APRIL 26, 2023

The therapy also showed a reduction in need or eligibility for SRT Ref: Businesswire | Image: Bristol Myers Squibb Related News:- BMS’ Camzyos (mavacamten) Receives the US FDA’s Approval for the Treatment of Symptomatic New York Heart Association Class II-III Obstructive HCM

FDA 40

FDA 40

The Checkup by Singlecare

MARCH 7, 2024

Wegovy is the first weight loss drug approved by the Food and Drug Administration (FDA) since 2014. The FDA approved Wegovy for weight loss for adults with a body max index (BMI) of 30 or higher and for adults with a BMI of 27 or higher with at least one weight-related health condition, such as heart disease).

Insurance 85

Insurance FDA 85

PharmaShots

FEBRUARY 10, 2023

The results from (DELTA 2) trial will be planned to submit for scientific presentation and publication LEO & Japan Tobacco collaborated in 2014 in which LEO gained exclusive rights to develop & commercialize delgocitinib for topical use in dermatological indications globally & JT retains rights in Japan Ref: Businesswire | Image: LEO Pharma (..)

FDA 40

FDA 40

Pharmaceutical Technology

JUNE 12, 2023

A US Food and Drug Administration (FDA) Advisory Committee (AdCom) has unanimously voted in support of Eisai and Biogen’s Leqembi and its clinical benefit in patients with early Alzheimer’s disease , raising the drug’s full approval prospects. Notably, an FDA AdCom voted largely against Aduhelm in November 2020.

Medical Schools 52

Medical Schools FDA Labelling 52

The FDA Law Blog

MARCH 8, 2023

Manufacturers who submit reports via the FDA Electronic Submissions Gateway are being advised to update their systems by this time. Background FDA first introduced the final rule and guidance on eMDR in 2014 , which we blogged about here. Either way, the information is transmitted to FDA via the ESG. b)(1)(iii).

Packaging 59

Packaging FDA Communication 59

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.

Controlled Substances 116

Controlled Substances FDA 116

pharmaphorum

NOVEMBER 11, 2022

Viehbacher led Sanofi between 2008 and 2014 and has decades of experience with both large pharmaceutical companies and small biotechs. However, in 2014 Sanofi fired Viehbacher over a boardroom fight regarding his management. — Bloomberg (@business) November 10, 2022. Biogen’s shares rose 2.4% to $289.01

Pharmaceutical Companies 40

Pharmaceutical Companies Pharmaceutical Companies Insurance FDA 40