Blog
RSS FeedPosted by Michael Wonder on 09 Oct 2024
CPO301 receives fast track designation from the US FDA
8 October 2024 - The board of directors of CSPC Pharmaceutical Group is pleased to announce that CPO301, a first ...
Posted by Michael Wonder on 09 Oct 2024
Zealand Pharma provides US regulatory update on dasiglucagon in congenital hyperinsulinism
9 October 2024 - The re-inspection of the facility was completed in August/September 2024 for which a new inspection classification is ...
Posted by Michael Wonder on 09 Oct 2024
Teva Prolia (denosumab) biosimilar candidate is accepted for review by US FDA and EU EMA
8 October 2024 - TVB-009P, Teva’s proposed biosimilar to Prolia, showed Phase 3 clinical results in osteoporosis and is part of ...
Posted by Michael Wonder on 09 Oct 2024
FDA approves use of up to three tubes of Biofrontera's Ameluz (aminolevulinic acid hydrochloride) 10% topical gel in one treatment
7 October 2024 - Supplemental new drug application supported by two Phase 1 safety studies. ...
Posted by Michael Wonder on 08 Oct 2024
Boehringer receives US FDA breakthrough therapy designation and initiates two Phase 3 trials in MASH for survodutide
8 October 2024 - The US FDA breakthrough therapy designation is for the treatment of adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis ...
Posted by Michael Wonder on 08 Oct 2024
The FDA approved a self-administered nasal spray for the flu. Here’s how it compares to the traditional flu shot.
6 October 2024 - The US FDA recently approved FluMist as a self or caregiver-administered nasal spray flu vaccine to prevent ...
Posted by Michael Wonder on 08 Oct 2024
Indivior's Sublocade rapid induction/alternative injection site prior approval supplement receives FDA priority review
7 October 2024 - Indivior today announced the prior approval supplement for Sublocade (buprenorphine extended release) injection submitted by Indivior has ...
Posted by Michael Wonder on 08 Oct 2024
Neuvivo seeks FDA approval for its breakthrough ALS treatment NP001
7 October 2024 - Neuvivo today announced it submitted a new drug application to the US FDA for NP001 (sodium chlorite ...
Posted by Michael Wonder on 07 Oct 2024
Ultragenyx receives breakthrough therapy designation for setrusumab (UX143) in osteogenesis imperfecta
7 October 2024 - Ultragenyx today announced that it has received breakthrough therapy designation from the US FDA for setrusumab (UX143) ...
Posted by Michael Wonder on 07 Oct 2024
Crossing the equity chasm: addressing a second valley of death in biomedical innovation
3 October 2024 - Traditionally, the term valley of death refers to the gap where advancements in basic research fail to ...
Posted by Michael Wonder on 07 Oct 2024
Confirmatory trials of accelerated approval drugs — will imposing fines reduce delays?
5 October 2024 - In 1992, patient advocacy groups convinced the FDA to develop an accelerated approval program, which allowed new ...
Posted by Michael Wonder on 04 Oct 2024
Aldeyra Therapeutics resubmits reproxalap new drug application for the treatment of dry eye disease
3 October 2024 - Aldeyra Therapeutics today announced the resubmission of a new drug application to the US FDA for topical ...
Posted by Michael Wonder on 04 Oct 2024
FDA approves neo-adjuvant/adjuvant nivolumab for resectable non-small cell lung cancer
3 October 2024 - Today, the FDA approved nivolumab (Opdivo, Bristol Myers Squibb) with platinum-doublet chemotherapy as neo-adjuvant treatment, followed ...
Posted by Michael Wonder on 03 Oct 2024
Calquence granted priority review in the US for patients with untreated mantle cell lymphoma
3 October 2024 - Submission to be reviewed under Project Orbis. ...
Posted by Michael Wonder on 03 Oct 2024
Volastra Therapeutics granted FDA fast track designation for novel KIF18A inhibitor in ovarian cancer
2 October 2024 - Volastra Therapeutics today announced that the US FDA has granted fast track designation to VLS-1488, the company’s ...