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RSS FeedPosted by Michael Wonder on 24 Sep 2023
US FDA approves Jardiance for the treatment of adults with chronic kidney disease
22 September 2023 - Jardiance (empagliflozin) 10 mg tablets significantly reduced the risk of kidney disease progression and cardiovascular death in ...
Posted by Michael Wonder on 21 Sep 2023
Alvotech provides US regulatory update on AVT02, a high concentration interchangeable biosimilar candidate to Humira (adalimumab)
20 September 2023 - Alvotech announced today that the US FDA has accepted Alvotech’s resubmitted biologics license application for AVT02, a ...
Posted by Michael Wonder on 21 Sep 2023
FDA grants priority review to Merck’s application for Keytruda (pembrolizumab) plus concurrent chemoradiotherapy as treatment for patients with newly diagnosed high risk locally advanced cervical cancer
20 September 2023 - Acceptance based on results from the Phase 3 KEYNOTE-A18 trial, which showed a statistically significant and clinically ...
Posted by Michael Wonder on 20 Sep 2023
Takeda announces FDA acceptance of NDA resubmission of TAK-721 (budesonide oral suspension) for the short-term treatment of eosinophilic oesophagitis
20 September 2023 – Takeda today announced that the US FDA has accepted for review its new drug application resubmission ...
Posted by Michael Wonder on 19 Sep 2023
UCB provides update on US regulatory review of bimekizumab
19 September 2023 - UCB today provided an update on the biologics license application for bimekizumab for the treatment of ...
Posted by Michael Wonder on 19 Sep 2023
Altuviiio supplemental biologics license application based on positive final results from Phase 3 XTEND-Kids study accepted by FDA
12 September 2023 - Final results from XTEND-Kids study were submitted for review, potentially expanding on the interim data included in ...
Posted by Michael Wonder on 19 Sep 2023
FDA accepts for priority review Merck’s supplemental new drug application for Welireg (belzutifan) in certain previously treated patients with advanced renal cell carcinoma
19 September 2023 - Acceptance based on results from the Phase 3 LITESPARK-005 trial, which showed a statistically significant and clinically ...
Posted by Michael Wonder on 19 Sep 2023
Orchard Therapeutics announces acceptance of biologics license application for OTL-200 in MLD and receives priority review
18 September 2023 - PDUFA date set for 18 March 2024. ...
Posted by Michael Wonder on 18 Sep 2023
Orexo submits new drug application to FDA for OX124, a high-dose rescue medication for opioid overdose
18 September 2023 - OX124 is based on Orexo´s world-class drug delivery platform amorphOX and is designed to reverse the effect ...
Posted by Michael Wonder on 15 Sep 2023
Day One announces updated FIREFLY-1 data for tovorafenib and completion of rolling NDA submission to FDA for relapsed or progressive pediatric low-grade glioma
11 September 2023 - FDA filing decision expected by mid November. ...
Posted by Michael Wonder on 15 Sep 2023
US. FDA updates PDUFA action date for lifileucel for the treatment of advanced melanoma
14 September 2023 - FDA extends PDUFA date to 24 February 2024 on resource constraints and agrees to work with ...
Posted by Michael Wonder on 14 Sep 2023
Arcutis submits roflumilast cream 0.15% supplemental new drug application to the FDA for the treatment of atopic dermatitis in adults and children ages 6 years and older
12 September 2023 - In pivotal Phase 3 trials, roflumilast cream demonstrated statistically significant improvements over vehicle on the primary endpoint ...
Posted by Michael Wonder on 13 Sep 2023
Takeda announces FDA acceptance of BLA for subcutaneous administration of Entyvio (vedolizumab) for maintenance therapy in moderately to severely active Crohn’s disease
13 September 2023 - Applications for investigational subcutaneous administrations for both Crohn’s disease and ulcerative colitis are now under review by ...
Posted by Michael Wonder on 13 Sep 2023
Madrigal Pharmaceuticals announces NDA acceptance and priority review of the new drug application for resmetirom for the treatment of NASH with liver fibrosis
13 September 2023 - Madrigal Pharmaceuticals today announced that the US FDA has accepted for review its new drug application for ...
Posted by Michael Wonder on 13 Sep 2023
Formycon announces file acceptance for FYB203, a biosimilar candidate to Eylea (aflibercept), by the US FDA
29 August 2023 - Formycon and its license partner Klinge Biopharma announce that the US FDA has accepted the biologics license ...