Blog
RSS FeedPosted by Michael Wonder on 28 Jan 2022
Updates on Olumiant (baricitinib) FDA review for atopic dermatitis
28 January 2022 - Eli Lilly and Incyte today announced updates on the Phase 3 development program for Olumiant (baricitinib) in ...
Posted by Michael Wonder on 26 Jan 2022
Incyte provides update on parsaclisib and MCLA-145
25 January 2022 - Incyte today announced updates regarding the clinical development of parsaclisib, the Company’s next-generation oral inhibitor of ...
Posted by Michael Wonder on 25 Jan 2022
Genentech’s Evrysdi (risdiplam) granted FDA priority review for treatment of presymptomatic babies under 2 months of age with spinal muscular atrophy
24 January 2022 - Interim data submitted to the FDA show majority of pre-symptomatic babies treated with Evrysdi for at least ...
Posted by Michael Wonder on 24 Jan 2022
Merck provides U.S. and Japan regulatory update for gefapixant
24 January 2022 - Merck today announced that the U.S. FDA has issued a complete response letter regarding Merck’s New Drug ...
Posted by Michael Wonder on 20 Jan 2022
Omeros confirms submission of response to FDA regarding the BLA for narsoplimab in the treatment of HSCT-TMA
19 January 2022 - Omeros Corporation today confirmed that earlier this month the company submitted to the U.S. FDA its response ...
Posted by Michael Wonder on 19 Jan 2022
FDA accepts for review Libtayo (cemiplimab-rwlc) in combination with chemotherapy for first-line treatment of advanced NSCLC
19 January 2022 - Regulatory filing recently submitted in the European Union. ...
Posted by Michael Wonder on 19 Jan 2022
CANbridge Pharmaceuticals CAN108 new drug application for Alagille syndrome accepted by China’s National Medical Products Administration
17 January 2022 - Priority review expected to be granted. ...
Posted by Michael Wonder on 18 Jan 2022
bluebird provides update on FDA review timelines for betibeglogene autotemcel for beta thalasszemia and elivaldogene autotemcel for cerebral adrenoleukodystrophy
18 January 2022 - FDA PDUFA goal dates for both therapies extended by three months. ...
Posted by Michael Wonder on 17 Jan 2022
Enhertu granted priority review in the U.S. for patients with HER2 positive metastatic breast cancer treated with a prior anti-HER2 based regimen
17 January 2022 - Application being evaluated under FDA Real-Time Oncology Review and Project Orbis ...
Posted by Michael Wonder on 14 Jan 2022
GSK and Vir submit emergency use authorisation application to FDA for intramuscular administration of sotrovimab for the early treatment of COVID-19
13 January 2022 - Submission follows COMET-TAIL Phase 3 data demonstrating that intramuscular administration of sotrovimab was non-inferior and offered ...
Posted by Michael Wonder on 13 Jan 2022
The US FDA issues a complete response letter for the biologics license application for insulin aspart
7 January 2022 - The U.S. FDA has issued a complete response letter for the biologics license application for insulin ...
Posted by Michael Wonder on 13 Jan 2022
Mitsubishi Tanabe Pharma America announces FDA acceptance of new drug application for oral edaravone formulation for the treatment of ALS
12 January 2022 - Mitsubishi Tanabe Pharma America today announced the U.S. FDA has accepted the new drug application for an ...
Posted by Michael Wonder on 10 Jan 2022
EMA receives application for conditional marketing authorisation for Paxlovid (PF-07321332 and ritonavir) for treating patients with COVID-19
10 January 2022 - EMA has started evaluating an application for a conditional marketing authorisation for the oral antiviral medicine ...
Posted by Michael Wonder on 07 Jan 2022
AbbVie submits applications for upadacitinib (Rinvoq) in non-radiographic axial spondyloarthritis to U.S. FDA and EMA
7 January 2022 - Submissions supported by Phase 3 study in which upadacitinib (Rinvoq) demonstrated significant improvements in signs and symptoms ...
Posted by Michael Wonder on 05 Jan 2022
Amylyx Pharmaceuticals submits marketing authorisation application for AMX0035 for the Treatment of ALS
4 January 2022 - Amylyx Pharmaceuticals today announced it has submitted a marketing authorisation application to the EMA's CHMP for ...