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RSS FeedPosted by Michael Wonder on 19 Mar 2019
Biohaven secures priority review voucher to expedite regulatory review of Rimegepant Zydis ODT new drug application
18 March 2019 - Rimegepant Zydis orally disintegrating tablet is Biohaven's lead oral CGRP receptor antagonist drug candidate from its Nojection ...
Posted by Michael Wonder on 19 Mar 2019
GW Pharmaceuticals announces the sale of priority review voucher for $105 million
18 March 2019 - GW Pharmaceuticals today announced that GW Research Ltd. has entered into a definitive agreement to sell its ...
Posted by Michael Wonder on 19 Mar 2019
Boehringer Ingelheim announces FDA and EMA regulatory submission for nintedanib in systemic sclerosis associated ILD
18 March 2019 - Systemic sclerosis, also known as scleroderma, is a rare chronic connective tissue disease. ...
Posted by Michael Wonder on 18 Mar 2019
U.S. FDA accepts BLA filing of Aimmune Therapeutics’ AR101 for peanut allergy
18 March 2019 - If approved, AR101 will be the first medicine for this life-threatening condition. ...
Posted by Michael Wonder on 18 Mar 2019
Allergan announces FDA approval of Avycaz (ceftazidime and avibactam) for paediatric patients
18 March 2019 - Label now includes new data on use of Avycaz for treatment of cUTI and cIAI in paediatric ...
Posted by Michael Wonder on 18 Mar 2019
The policy initiatives Scott Gottlieb championed at the FDA will remain after he departs
18 March 2019 - The resignation of Scott Gottlieb as commissioner of the Food and Drug Administration raises a big ...
Posted by Michael Wonder on 18 Mar 2019
CytoDyn reaches historical milestone, submits first of three sections of BLA to FDA for leronlimab (PRO 140) as a combination therapy for HIV
18 March 2019 - FDA previously granted rolling review for BLA. ...
Posted by Michael Wonder on 17 Mar 2019
Statement from FDA Commissioner and Director of the Center for Devices and Radiological Health on efforts to evaluate materials in medical devices to address potential safety questions
15 March 2019 - We’re in an unprecedented era of innovation in medical devices with advances in materials science that ...
Posted by Michael Wonder on 15 Mar 2019
Spectrum Pharmaceuticals provides BLA filing update for Rolontis (eflapegrastim)
15 March 2019 - Spectrum Pharmaceuticals announced today that due to the U.S. FDA's request for additional manufacturing-related information for ...
Posted by Michael Wonder on 15 Mar 2019
Eton Pharmaceuticals submits new drug application for DS-200
14 March 2019 - FDA previously granted DS-200 fast track designation. ...
Posted by Michael Wonder on 15 Mar 2019
Karyopharm announces FDA extension of review period for selinexor new drug application
14 March 2019 - PDUFA action date extended by three months to July 6, 2019. ...
Posted by Michael Wonder on 14 Mar 2019
Patient advocates applaud Cancer Drug Parity Act filed in both the U.S. House and Senate
13 March 2019 - The Coalition to Improve Access to Cancer Care and its members from across the cancer patient ...
Posted by Michael Wonder on 14 Mar 2019
Statement by FDA Commissioner on new strategies to modernise clinical trials to advance precision medicine, patient protections and more efficient product development
14 March 2019 - Modernizing clinical trials is an agency wide priority. ...
Posted by Michael Wonder on 14 Mar 2019
How Eli Lilly’s new generic insulin could impact prices across the market
14 March 2019 - The list price is $137.35 per vial. ...
Posted by Michael Wonder on 14 Mar 2019
FDA grants Purdue Pharma’s nalmefene hydrochloride injection fast track designation for the emergency treatment of known or suspected opioid overdose
13 March 2019 - Committed to advancing solutions to the opioid public health crisis, Purdue will not profit from nalmefene hydrochloride. ...