Blog
RSS FeedPosted by Michael Wonder on 26 Jun 2020
FDA approves new therapy for Dravet syndrome
25 June 2020 - The U.S. FDA today approved Fintepla (fenfluramine), a Schedule IV controlled substance, for the treatment of seizures ...
Posted by Michael Wonder on 25 Jun 2020
Aadi Bioscience initiates rolling submission of NDA to FDA for nab-sirolimus (ABI-009, Fyarro) for the treatment of advanced malignant PEComa
25 June 2020 - Long-term follow-up data released at ASCO 2020 for AMPECT study. ...
Posted by Michael Wonder on 25 Jun 2020
Partnering with the European Union and global regulators on COVID-19
25 June 2020 - The European Union is one of the U.S. Food and Drug Administration’s most important collaborators in tackling ...
Posted by Michael Wonder on 25 Jun 2020
First COVID-19 treatment recommended for EU authorisation
25 June 2020 - EMA’s human medicines committee has recommended granting a conditional marketing authorisation to Veklury (remdesivir) for the ...
Posted by Michael Wonder on 25 Jun 2020
Emer Cooke nominated as new EMA Executive Director
25 June 2020 - The EMA Management Board has nominated Emer Cooke as the new Executive Director of the Agency. ...
Posted by Michael Wonder on 24 Jun 2020
US painkiller to be sold in Australian pharmacies to shore up supply
25 June 2020 - Global pharmaceutical giant Johnson & Johnson has been given approval to sell its US painkiller brand ...
Posted by Michael Wonder on 24 Jun 2020
FDA approves pembrolizumab for cutaneous squamous cell carcinoma
24 June 2020 - Today the FDA approved pembrolizumab (Keytruda, Merck & Co) for patients with recurrent or metastatic cutaneous ...
Posted by Michael Wonder on 24 Jun 2020
The new Janet: the FDA turns to a quiet problem-solver who brings expertise — and a little controversy
23 June 2020 - Janet Woodcock, one of the FDA’s most powerful regulators, has an almost mythic reputation and an ...
Posted by Michael Wonder on 24 Jun 2020
NeuroRx and Relief Therapeutics announce fast track designation granted by the FDA to RLF-100 (aviptadil) for the treatment of respiratory distress in COVID-19
24 June 2020 - At the FDA’s request, NeuroRx is submitting an expanded access policy enabling physicians to request RLF-100 for ...
Posted by Michael Wonder on 24 Jun 2020
Big pharma is taking big money from U.S. tax payers to find a coronavirus vaccine — and charge whatever they want for it
24 June 2020 - Congress must act now to ensure that COVID-19 vaccines and treatments are affordable. ...
Posted by Michael Wonder on 24 Jun 2020
Mayne Pharma announces FDA filing acceptance of new drug application for E4/DRSP in the US
24 June 2020 - Mayne Pharma is pleased to announce the new drug application for E4/DRSP to prevent pregnancy has been ...
Posted by Michael Wonder on 24 Jun 2020
Global regulators discuss data requirements for phase 3 trials of COVID-19 vaccines
24 June 2020 - Under the umbrella of the International Coalition of Medicines Regulatory Authorities, international regulators discussed COVID-19 vaccine ...
Posted by Michael Wonder on 24 Jun 2020
Renibus Therapeutics receives FDA fast track designation for RBT-9 treatment in COVID-19
23 June 2020 - Renibus Therapeutics announced today that it has been granted fast track designation by the FDA for RBT-9 ...
Posted by Michael Wonder on 23 Jun 2020
Polynoma receives FDA fast track designation for its melanoma cancer vaccine seviprotimut-L
23 June 2020 - Polynoma announces that the U.S. FDA has granted its application for fast track designation of seviprotimut-L, ...
Posted by Michael Wonder on 23 Jun 2020
FDA maintains the pace of meeting its goals on applications for medical products during the pandemic
23 June 2020 - One of the challenges facing the FDA during the COVID-19 pandemic is how to ensure the ...