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 Companies Pharmaceutical Companies FDA 59

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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FDA 105

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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FDA 98

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.

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FDA 120

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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FDA Documentation 100

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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FDA 87

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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Controlled Substances Labelling 52

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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Insurance FDA Hospitals 118

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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FDA Chemotherapy Labelling 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.

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FDA Dosage 95

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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FDA 105

STAT

AUGUST 1, 2024

authored the Sunscreen Innovation Act , which became law in 2014, Americans are still waiting for newer, more effective sunscreen products due to the Food and Drug Administration’s chronic inaction. A decade after Sen. Jack Reed (D-R.I.)

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FDA 127

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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FDA Pharmaceutical Companies Pharmaceutical Companies 123

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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FDA 59

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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FDA 94

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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FDA 52

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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FDA 52

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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FDA Labelling 66

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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FDA Research Laboratories Documentation 69

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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Dosage Labelling FDA 97

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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FDA 96

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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FDA Hospitals Immunization 81

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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FDA Controlled Substances 116

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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FDA 98

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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Immunization Chemotherapy Compounding FDA 105

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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FDA Dosage 52

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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FDA 98

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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FDA 101

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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FDA Documentation Communication 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.

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FDA Labelling 52

The FDA Law Blog

AUGUST 12, 2024

As with other FDA-regulated products, such as human drugs and medical devices, the “regulatory review period” is composed of a “testing phase” and a “review phase.” FDA’s PTE regulations at 21 C.F.R. FDA guidance has been clear that that point for rolling submissions is when the last component has been submitted.

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FDA 59

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.

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FDA 40

pharmaphorum

JUNE 15, 2021

Biogen has made no secret of its aspirations in gene therapy, setting up a dedicated business unit for the category in 2014 and following that with a $1 billion alliance with Applied Genetic Technologies in 2015 – terminated three years later.

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FDA 105

Pharmaceutical Technology

MAY 16, 2023

The AMP was launched in 2014 as a partnership between the FDA , the National Institutes for Health, and several public and private organisations. BGTC will likely simultaneously work towards multiple IND applications for different diseases, she added. The BGTC was launched in October 2021, as the first AMP initiative.

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FDA 90

pharmaphorum

MARCH 8, 2021

The new indication for the Merck & Co/MSD-partnered drug – which is also used to treat ovarian, breast and pancreatic cancer – was approved by the EMA last year with a slightly more restricted label than was previous cleared by the FDA.

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Chemotherapy Labelling FDA 98