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RSS FeedPosted by Michael Wonder on 08 Nov 2021
Why does the FDA want to stop improving medicines via patent ‘areas of concern’?
8 November 2021 - It’s hardly unprecedented for one federal agency to encroach on another’s turf. But the latest intra-executive-branch ...
Posted by Michael Wonder on 08 Nov 2021
AZ announces US fast track designation for IL-5 inhibitor Fasenra
8 November 2021 - AstraZeneca’s IL-5 inhibitor Fasenra (benralizumab) has received a fast track designation from the US FDA for ...
Posted by Michael Wonder on 08 Nov 2021
COVID-19: EMA and Heads of Medicines Agencies update on molnupiravir
8 November 2021 - EMA starts review to support possible national decisions on early use. ...
Posted by Michael Wonder on 08 Nov 2021
FDA grants tentative approval for Liquidia’s Yutrepia (treprostinil) inhalation powder
8 November 2021 - Final FDA approval may occur in October 2022 or earlier upon resolution of on-going litigation. ...
Posted by Michael Wonder on 08 Nov 2021
Azurity Pharmaceuticals announces FDA approval of Eprontia (topiramate) oral solution
8 November 2021 - The first and only FDA approved ready to use liquid topiramate. ...
Posted by Michael Wonder on 07 Nov 2021
EffRx obtains Swiss marketing authorization for Bronchitol in cystic fibrosis
4 November 2021 - EffRx Pharmaceuticals today announced that Swissmedic has approved Bronchitol (inhaled mannitol) for the treatment of cystic fibrosis ...
Posted by Michael Wonder on 07 Nov 2021
Ocugen announces submission of emergency use authorisation request to the US FDA for investigational COVID-19 vaccine Covaxin (BBV152) for children ages 2-18 years
5 November 2021 - Paediatric EUA submission based on immuno-bridging clinical trial in children, ages 2-18, demonstrating comparable neutralising antibody response ...
Posted by Michael Wonder on 07 Nov 2021
AstraZeneca pulls request for Swiss approval of COVID shot
5 November 2021 - AstraZeneca says it is withdrawing its application for approval of its COVID-19 vaccine in Switzerland because the ...
Posted by Michael Wonder on 06 Nov 2021
Tris Pharma announces FDA approval of Dyanavel XR (amphetamine) once daily extended release oral tablets, CII, for ADHD
5 November 2021 - In a clinical study in adults, Dyanavel XR tablets demonstrated bioequivalence to Dynavel XR (amphetamine) extended-release oral ...
Posted by Michael Wonder on 05 Nov 2021
FDA awards breakthrough device designation to the ReWalk ReBoot Soft Exo-Suit
4 November 2021 - Soft exoskeleton device for stroke survivors will be for use at home and in the community ...
Posted by Michael Wonder on 05 Nov 2021
AstraZeneca Canada files for Health Canada authorisation of AZD7442 for prevention of COVID-19
3 November 2021 - AstraZeneca Canada has initiated a rolling review new drug submission with Health Canada for authorization of ...
Posted by Michael Wonder on 04 Nov 2021
Opiant receives FDA fast track designation for OPNT003, nasal nalmefene, for treatment of opioid overdose
4 November 2021 - Fast track designation further underscores the potential for OPNT003 to represent a major advance in the treatment ...
Posted by Michael Wonder on 04 Nov 2021
Libtayo (cemiplimab) approved in Canada for the first-line treatment of adult patients with non-small-cell lung cancer expressing PD-L1 in ≥ 50% of tumour cells with no EGFR, ALK or ROS1 aberrations
29 October 2021 - The approval is based on data from the randomised, open-label, multi-center study 16241. ...
Posted by Michael Wonder on 04 Nov 2021
TGA approves Illuccix for prostate cancer imaging
2 November 2021 - Telix is delighted to announce that the TGA has approved Illuccix (kit for the preparation of ...
Posted by Michael Wonder on 04 Nov 2021
Libtayo (cemiplimab) approved in Canada for locally advanced basal cell carcinoma patients
29 October 2021 - The approval is based on data from the open-label, multi-center, non-randomised study 16201. ...