Blog
RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
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 06 Nov 2021
NICE recommend dapagliflozin for people with chronic kidney disease
5 November 2021 - In draft guidance published today NICE has recommended dapagliflozin as an option for treating certain people ...
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 05 Nov 2021
Drug Utilisation Sub-Committee outcome statement
5 November 2021 - The Outcome Statement from the October 2021 Drug Utilisation SubCommittee meeting is now available. ...
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
UK approval for MSD/Ridgeback’s COVID-19 anti-viral medicine
4 November 2021 - The UK MHRA has authorised MSD and Ridgeback Therapeutics’ COVID-19 anti-viral medicine molnupiravir. ...
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. ...
Posted by Michael Wonder on 04 Nov 2021
OS Therapies receives rare paediatric disease designation in osteosarcoma for OST-HER2 (Listeria monocytogenes)
3 November 2021 - Pathway to priority review voucher and expedited review by the FDA. ...
Posted by Michael Wonder on 04 Nov 2021
Impact of Medicare only limits on drug prices
4 November 2021 - Congress is considering legislation that would set limits on drug prices through price negotiation for certain high-cost, ...
Posted by Michael Wonder on 04 Nov 2021
Lipocine announces FDA grants fast track designation to LPCN 1144 for treatment of non-cirrhotic NASH
4 November 2021 - Lipocine today announced that the U.S. FDA has granted fast track designation to LPCN 1144 as a ...
Posted by Michael Wonder on 04 Nov 2021
ICER publishes evidence report on tezepelumab for severe asthma
4 November 2021 - Tezepelumab reduces asthma exacerbations, but there is uncertainty about long-term safety as with all new biologic ...
Posted by Michael Wonder on 04 Nov 2021
NICE recommends Namuscla for NHS to treat genetic disorder
4 November 2021 - NICE has published draft guidance which recommends a rebranded form of the drug mexiletine (Namuscla), for ...