Blog
RSS FeedPosted by Michael Wonder on 04 Dec 2019
FDA approves Genentech’s Tecentriq plus chemotherapy (Abraxane and carboplatin) for the initial treatment of metastatic non-squamous non-small cell lung cancer
3 December 2019 - Approval based on the Phase III IMpower130 study showing the Tecentriq plus chemotherapy combination demonstrated a significant ...
Posted by Michael Wonder on 03 Dec 2019
Regenerative medicine advanced therapy designation granted by FDA to ADP‑A2M4 for the treatment of synovial sarcoma
3 December 2019 - Will enable expedited development and review of ADP-A2M4 with the goal of commercialisation in 2022 for patients ...
Posted by Michael Wonder on 03 Dec 2019
Trends in the price per median and mean life-year gained among newly approved cancer therapies 1995 to 2017
2 December 2019 - The prices of newly approved cancer drugs have risen over the past decades. ...
Posted by Michael Wonder on 03 Dec 2019
Aquestive Therapeutics completes rolling submission of new drug application to U.S. Food and Drug Administration for Libervant (diazepam) buccal film for management of seizure clusters
2 December 2019 - Aquestive Therapeutics today announced the completion, as planned, of the rolling submission of a new drug ...
Posted by Michael Wonder on 03 Dec 2019
Clarifying the meaning of clinically meaningful benefit in clinical research: noticeable change vs valuable change
2 December 2019 - Recent years have witnessed an increasing focus on the input of patients, their caregivers, or both to ...
Posted by Michael Wonder on 03 Dec 2019
Cumberland Pharmaceuticals receives FDA approval for RediTrex product line
2 December 2019 - Cumberland Pharmaceuticals today announced that it has received approval from the U.S. FDA for RediTrex, its ...
Posted by Michael Wonder on 02 Dec 2019
FDA grants priority review to Merck’s supplemental biologics license application for Keytruda (pembrolizumab) in certain patients with high-risk, non-muscle invasive bladder cancer (NMIBC)
2 December 2019 - Application based on results from Phase 2 KEYNOTE-057 trial, to be discussed at December FDA Oncologic Drugs ...
Posted by Michael Wonder on 02 Dec 2019
Diurnal files adrenal insufficiency drug Alkindi in US
2 December 2019 - Could become only treatment for children with the condition. ...
Posted by Michael Wonder on 02 Dec 2019
Lexicon Pharmaceuticals receives formal dispute resolution request decision from FDA’S office of new drugs for sotagliflozin in type 1 diabetes
2 December 2019 - Lexicon Pharmaceuticals today announced that the Office of New Drugs of the U.S. FDA has reiterated the ...
Posted by Michael Wonder on 02 Dec 2019
Innovent Biologics announces FDA acceptance of NDA for pemigatinib in patients with previously treated, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements
1 December 2019 - Innovent Biologics today announced that the new drug application submitted by Incyte to the U.S. FDA for ...
Posted by Michael Wonder on 01 Dec 2019
Adaptive design clinical trials for drugs and biologics guidance for industry
29 November 2019 - This document provides guidance to sponsors and applicants submitting investigational new drug applications, new drug applications, biologics ...
Posted by Michael Wonder on 01 Dec 2019
U.S. Food and Drug Administration anticancer drug approval trends from 2016 to 2018 for lung, colorectal, breast, and prostate cancer
28 November 2019 - This paper aims to describe the clinical and regulatory aspects of new drugs and indications that ...
Posted by Michael Wonder on 30 Nov 2019
Y-mAbs initiates rolling submission of biologics license application to U.S. FDA for naxitamab for treatment of neuroblastoma
29 November 2019 - Y-mAbs Therapeutics today announced that it has submitted to the U.S. FDA the first portions of ...
Posted by Michael Wonder on 30 Nov 2019
Imfinzi granted FDA priority review for the treatment of patients with extensive-stage small cell lung cancer
29 November 2019 - AstraZeneca today announced that the US FDA has accepted a supplemental biologics license application and granted ...
Posted by Michael Wonder on 28 Nov 2019
Verrica Pharmaceuticals announces FDA filing acceptance of new drug application for VP-102 for the treatment of molluscum contagiosum
27 November 2019 - PDUFA date assigned is 13 July 2020. ...