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 15 Dec 2020
U.S. FDA accepts new drug application for review, grants priority review for Takeda’s TAK-721 (budesonide oral suspension) for the treatment of eosinophilic oesophagitis
15 December 2020 - If approved, TAK-721 will be the first FDA approved treatment for the chronic inflammatory disease; Takeda plans ...
Posted by Michael Wonder on 15 Dec 2020
FDA awards Genetesis breakthrough device designation for CardioFlux imaging technology
15 December 2020 - Genetesis announced today that its flagship product, CardioFlux, has been granted Breakthrough Device Designation by the U.S. ...
Posted by Michael Wonder on 15 Dec 2020
Update on assessment of the BioNTech and Pfizer BNT162b2 vaccine marketing authorisation application
15 December 2020 - EMA’s CHMP and its experts have been working intensively over the past weeks to evaluate data ...
Posted by Michael Wonder on 15 Dec 2020
28 state Attorneys General demand HHS Secretary Azar enforce laws on 340B drug pricing
14 December 2020 - AIDS Healthcare Foundation praised 28 U.S. state attorneys general who have drawn a line in the sand ...
Posted by Michael Wonder on 15 Dec 2020
Almirall announces FDA approval of Klisyri (tirbanibulin), a new innovative topical treatment for actinic keratosis
15 December 2020 - In one of the largest Phase 3 clinical trial programs ever conducted for a topical actinic keratosis ...
Posted by Michael Wonder on 15 Dec 2020
Imfinzi recommended for approval in the EU by CHMP for less-frequent, fixed-dose use in unresectable non-small cell lung cancer
15 December 2020 - Option would extend dosing from two to four weeks, reducing medical visits and improving patient convenience ...
Posted by Michael Wonder on 15 Dec 2020
European CHMP adopts positive opinion for Heplisav-B, Dynavax's two dose adult hepatitis B adjuvanted vaccine
10 December 2020 - If approved, Heplisav-B will be the only two dose adult hepatitis B vaccine offering protection in just ...
Posted by Michael Wonder on 15 Dec 2020
'Digital contraceptive' gets approval by Australian health authorities
15 December 2020 - A smartphone app can officially be used as a contraceptive tool by Australians after becoming the ...
Posted by Michael Wonder on 15 Dec 2020
FDA approves Genentech’s Ocrevus (ocrelizumab) shorter 2 hour infusion for relapsing and primary progressive multiple sclerosis
14 December 2020 - Approval based on data from the randomised, double-blind ENSEMBLE PLUS study, showing consistent safety to the conventional ...
Posted by Michael Wonder on 15 Dec 2020
COVID-19 vaccine codes: updated effective date for Pfizer-BioNTech
14 December 2020 - During the COVID-19 public health emergency, Medicare will cover and pay for the administration of the vaccine ...
Posted by Michael Wonder on 15 Dec 2020
AMAG Pharmaceuticals files submission in response to the FDA’s notice of opportunity for a hearing and proposal to withdraw approval of Makena (hydroxyprogesterone caproate injection)
14 December 2020 - AMAG Pharmaceuticals has submitted its response to the FDA’s Notice of Opportunity for a Hearing regarding the ...
Posted by Michael Wonder on 15 Dec 2020
Over-the-counter access to low dose cannabidiol
15 December 2020 - Today the Therapeutic Goods Administration announced a final decision to down-schedule certain low dose cannabidiol preparations ...
Posted by Michael Wonder on 14 Dec 2020
Australia secures 20 million extra Astra Zeneca vaccines
11 December 2020 - Australia secures 20 million extra Astra Zeneca vaccines for onshore manufacturing to cover entire population and a ...
Posted by Michael Wonder on 14 Dec 2020
Avelas receives FDA breakthrough therapy designation for pegloprastide (AVB-620) for use during breast cancer surgery
14 December 2020 - Avelas Biosciences today announced that the company has received breakthrough therapy designation from the U.S. FDA ...
Posted by Michael Wonder on 14 Dec 2020
U.S. Government exercises first option for additional 100 million doses of Moderna’s COVID-19 vaccine candidate
11 December 2020 - Additional doses ordered today will be delivered in Q2 2021. ...