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. Dupixent’s label currently calls for dosing every two weeks for all patients. Leo now says it will start rolling the new product out in February.

FDA 111

FDA Labelling 111

pharmaphorum

JUNE 8, 2021

The FDA “has failed in its responsibility to protect patients and families from unproven treatments with known harms” in approving Biogen’s Alzheimer’s disease drug Aduhelm. Broad label questioned. billion in 2027.

FDA 98

FDA Labelling 98

The FDA Law Blog

OCTOBER 24, 2022

355g(a), directed FDA to “establish a program to evaluate the potential use of real world evidence” both “to help to support the approval of a new indication” and “to help to support or satisfy postapproval study requirements.” The sponsor and FDA reach agreement on the study design information to be publicly disclosed.

FDA 78

FDA Labelling 78

pharmaphorum

JUNE 22, 2022

Qulipta (atogepant) is already approved for prevention of episodic migraine – where attacks are less frequent – getting the green light from the FDA last September for this use a few months after Biohaven and Pfizer’s Nurtec ODT (rimegepant). The post AbbVie files Qulipta for chronic migraine prevention appeared first on.

Labelling 69

Labelling FDA 69

The FDA Law Blog

OCTOBER 6, 2023

Javitt & Philip Won — As we reported last week, FDA has issued a 26 page, single spaced, tiny-font Proposed Rule of Laboratory Developed Tests (LDTs). The brevity of this change belies the foreseeably seismic impact of FDA regulation of clinical laboratories on the healthcare system. By Allyson B. Mullen & Gail H.

FDA 64

FDA Labelling 64

pharmaphorum

MARCH 11, 2022

Qulipta was approved by the FDA last September for the preventive treatment of episodic migraine, a few months later than its main rival in the oral CGRP category, Biohaven’s Nurtec ODT (rimegepant), got a green light for the same indication. billion by 2027.

Labelling 52

Labelling FDA 52

pharmaphorum

JANUARY 10, 2023

New drugs for immunological and inflammatory diseases feature prominently among new product launches this year that could top $1 billion in annual sales by 2027 or be clinical “game changers,” according to Clarivate.

FDA 52

FDA Labelling 52