FDA Law Blog

FEBRUARY 7, 2022

In the case of the Lilly Instagram posts, FDA expressed concern that the Instagram posts create a misleading impression with respect to the safety and effectiveness of a drug subject to a Boxed Warning rendering the drug misbranded.

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XTalks

AUGUST 17, 2020

In 2017, the US FDA approved a CAR-T cell treatment for young adults and children with B-cell ALL. The first class of Immuno-STAT molecules from Cue Biopharma contain an epitope-targeted peptide-HLA complex (signal 1) and a T cell activator i.e. molecules of IL-2 (signal 2) on an Fc antibody backbone. Image from Cue Biopharma.

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XTalks

AUGUST 2, 2023

Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. It contains the antiviral medications nirmatrelvir and ritonavir. In addition, the FDA approved Pfizer’s pneumococcal 20-valent conjugate vaccine, Prevnar 20, for the first time in June 2021.

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The Pharma Data

MAY 13, 2021

Fiber and protein will make you feel full faster, while carbs increase insulin level making you hungry. Every capsule is manufactured in the USA, in our FDA approved and GMP certified facility, under sterile, strict and precise standards. They do not contain any dangerous stimulants or toxins, and they are not habit forming.

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XTalks

FEBRUARY 8, 2024

Ozempic (Semaglutide) Ozempic sales in 2022: $8.713 billion Company/Developer: Novo Nordisk Date of first FDA approval: December 5, 2017 Indications Ozempic is FDA-approved for: Type 2 diabetes Price of Ozempic: $1,029 for 1.5 Read on to learn more about the top 15 diabetes drugs in 2023, based on 2022 sales statistics.

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Roots Analysis

AUGUST 27, 2024

The implantable neurostimulation systems usually contain sophisticated electronics, such as stimulating leads, internalized pulse generator, and electrode extenders to subcutaneously connect the leads to pulse generator which is packaged within a hermetically sealed titanium case.

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The Pharma Data

JULY 23, 2021

1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.

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The Pharma Data

MARCH 11, 2021

1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.

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The Pharma Data

APRIL 4, 2023

Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (la/mUC) who are not eligible for cisplatin-containing chemotherapy.

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Delveinsight

DECEMBER 7, 2020

In April 2018, the FDA approved IDx ‘s AI-based diagnostic system for the autonomous detection of diabetic retinopathy, a disorder that can lead to blindness. The device is worn on the patients’ body, which contains a biharmonic cartridge in it that carries insulin and glucagon.

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The Pharma Data

MAY 13, 2021

Low Level Light therapy (LLLT), is FDA approved for treating conditions such as chronic joint pain and slow to heal wounds. (3). Jonathan was in his late 40s and came into my pharmacy to pick up his insulin for his diabetes, when he told me about his father. Aloe Vera contains beneficial plant compounds that help alleviate pain.

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Pharmaceutical Technology

DECEMBER 4, 2022

There are seven FDA-approved Humira biosimilars, of which Amgen’s Amjevita will be launched in January. For example, the first-to-market status was beneficial when it came to insulin biosimilars. Also, some biosimilars contain citrate, while others like Abrilada do not.

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