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 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4 November 2021 - NICE has published draft guidance which recommends a rebranded form of the drug mexiletine (Namuscla), for ...
Posted by Michael Wonder on 04 Nov 2021
UNION therapeutics receives FDA fast track designation for oral orismilast for the treatment of moderate to severe atopic dermatitis
4 November 2021 - FDA's fast track designation for oral orismilast underscores the urgent need for new treatment option with potential ...
Posted by Michael Wonder on 04 Nov 2021
Epizyme receives fast track designation from U.S. FDA and announces initiation of Phase 1/1b study of its novel SETD2 inhibitor, EZM0414
4 November 2021 - Epizyme today announced that the U.S. FDA has granted fast track designation to EZM0414, the Company’s novel, ...
Posted by Michael Wonder on 04 Nov 2021
TecTraum’s pro2cool receives FDA designation as a breakthrough device for the treatment of concussions
3 November 2021 - TecTraum today announced that the U.S. FDA has designated its flagship technology, pro2cool, as a breakthrough ...
Posted by Michael Wonder on 04 Nov 2021
Funding hole makes cracking COVID-19 vaccine code a tougher ask
4 November 2021 - Australia has the expertise to crack the code in the biggest challenge facing the COVID-19 vaccination ...
Posted by Michael Wonder on 04 Nov 2021
A breakthrough treatment for cystic fibrosis needs funding now
3 November 2021 - Let’s just kick this off by addressing the elephant in the room. Trikafta, the breakthrough treatment ...
Posted by Michael Wonder on 04 Nov 2021
COVID-19 vaccine weekly safety report (4 November 2021)
4 November 2021 - To 31 October 2021, the TGA has received 253 reports which have been assessed as likely to ...
Posted by Michael Wonder on 03 Nov 2021
NICE releases guidance on medicine for patients with thyroid cancer
3 November 2021 - Selpercatinib is used to treat patients with advanced RET fusion positive thyroid cancer. ...
Posted by Michael Wonder on 03 Nov 2021
Trastuzumab deruxtecan type II variation application validated by EMA for the treatment of HER2 positive advanced gastric cancer
3 November 2021 - Application based on DESTINY-Gastric01 and DESTINY-Gastric02 phase 2 trials. ...
Posted by Michael Wonder on 03 Nov 2021
PhRMA statement on Democrats' drug pricing deal in reconciliation package
2 November 2021 - The following can be attributed to PhRMA President and CEO Stephen J. Ubl. ...
Posted by Michael Wonder on 03 Nov 2021
Valeo Pharma obtains public reimbursement for Enerzair Breezhaler and Atectura Breezhaler in Alberta
3 November 2021 - First provincial public listing secured for both asthma medications. ...
Posted by Michael Wonder on 03 Nov 2021
Coverage is available for COVID-19 vaccinations for eligible children ages 5 through 11
3 November 2021 - Following the U.S. FDA's recent action authorizing the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 in ...
Posted by Michael Wonder on 03 Nov 2021
TransThera receives fast track designation from FDA for its core product TT-00420 to treat cholangiocarcinoma
3 November 2021 - TransThera Sciences announced that the U.S. FDA has granted fast track designation to its phase II ...
Posted by Michael Wonder on 03 Nov 2021
AvroBio receives rare paediatric disease designation from the U.S. FDA for AVR-RD-05, a gene therapy for mucopolysaccharidosis type II or Hunter syndrome
3 November 2021 - AVROBIO today announced that the U.S. FDA has granted rare paediatric disease designation to AVR-RD-05, its ...
Posted by Michael Wonder on 03 Nov 2021
Allena Pharmaceuticals receives fast track designation from FDA for the development of ALLN-346 for chronic treatment of hyperuricemia in patients with gout and advanced chronic kidney disease
3 November 2021 - Novel oral therapeutic candidate ALLN-346 targets uric acid in the intestinal tract. ...