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RSS FeedPosted by Michael Wonder on 19 Sep 2022
Ascendis Pharma submits TransCon PTH new drug application to the US FDA for adult patients with hypoparathyroidism
31 August 2022 - European MAA on track for Q4, 2022 submission. ...
Posted by Michael Wonder on 13 Sep 2022
Clovis Oncology submits applications for Rubraca label expansion in the US and European Union as first-line maintenance treatment in women with advanced ovarian cancer
13 September 2022 - Submissions based on data from the Phase 3 ATHENA trial evaluating Rubraca monotherapy versus placebo (ATHENA-MONO) presented ...
Posted by Michael Wonder on 13 Sep 2022
BWXT Medical submits Tc 99m generator new drug application to FDA
13 September 2022 - Company highlights growing nuclear medicine product portfolio and future opportunities in therapeutic radioisotopes. ...
Posted by Michael Wonder on 13 Sep 2022
Otsuka and Lundbeck announce U.S. FDA acceptance of new drug application for aripiprazole 2 month, ready to use, long-acting injectable to treat schizophrenia and bipolar I disorder in adults
13 September 2022 - Filing is supported by a 32 week bridging trial in which aripiprazole 2 month showed comparable effectiveness ...
Posted by Michael Wonder on 12 Sep 2022
Acadia Pharmaceuticals announces trofinetide new drug application for the treatment of Rett syndrome has been accepted for filing and review by US FDA
12 September 2022 - Prescription Drug User Fee Act action date set for 12 March 2023. ...
Posted by Michael Wonder on 12 Sep 2022
Chiesi Global Rare Diseases announces FDA acceptance of BLA filing for velmanase alfa for the proposed treatment of alfa mannosidosis
12 September 2022 - FDA grants priority review designation with PDUFA date in the first half of 2023. ...
Posted by Michael Wonder on 12 Sep 2022
BioLineRx announces submission of new drug application to FDA for motixafortide in stem cell mobilisation
12 September 2022 - Submission based on overwhelmingly positive top-line results from GENESIS Phase 3 trial. ...
Posted by Michael Wonder on 09 Sep 2022
FDA and EMA accept regulatory submission for Pfizer’s ritlecitinib for individuals 12 years and older with alopecia areata
9 September 2022 - Filings based on clinical data demonstrating significant scalp hair regrowth versus placebo. ...
Posted by Michael Wonder on 07 Sep 2022
Seres Therapeutics announces completion of rolling BLA submission to FDA for investigational microbiome therapeutic SER-109 for recurrent C. difficile infection
7 September 2022 - Investigational therapeutic SER-109 has the potential to become the first-ever FDA approved oral microbiome therapeutic. ...
Posted by Michael Wonder on 07 Sep 2022
Tarsus submits new drug application to the FDA for TP-03 for the treatment of demodex blepharitis
7 September 2022 - Tarsus Pharmaceuticals today announced that it has submitted a new drug application to the US FDA for ...
Posted by Michael Wonder on 02 Sep 2022
First de novo deuterated drug poised for approval
1 September 2022 - Bristol Myers Squibb’s first in class TYK2 inhibitor and blockbuster contender deucravacitinib showcases the role for heavy ...
Posted by Michael Wonder on 31 Aug 2022
Amneal announces submission of new drug application to the US FDA for IPX203 for the treatment of Parkinson’s disease
31 August 2022 - IPX203 is a novel, extended-release oral formulation of carbidopa and levodopa that if approved, would offer patients ...
Posted by Michael Wonder on 31 Aug 2022
Aquestive Therapeutics receives FDA tentative approval for Libervant (diazepam) buccal film
31 August 2022 - Libervant US market access currently subject to the expiration of Valtoco orphan drug market exclusivity. ...
Posted by Michael Wonder on 30 Aug 2022
Outlook Therapeutics re-submits biologics license application for ONS-5010 as a treatment for wet AMD to the US FDA
30 August 2022 - Outlook Therapeutics today announced it has re-submitted its biologics license application to the U.S. FDA for ...
Posted by Michael Wonder on 30 Aug 2022
FDA grants priority review to efanesoctocog alfa for people with haemophilia A
30 August 2022 - Priority review based on pivotal data from the XTEND-1 Phase 3 study. ...