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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 24 Sep 2023
MicuRx receives FDA qualified infectious disease product and fast track designation for contezolid and contezolid acefosamil
22 September 2023 - MicuRx Pharmaceuticals today announced that the US FDA has granted Qualified Infectious Disease Product and the fast ...
Posted by Michael Wonder on 22 Sep 2023
89bio announces US FDA has granted breakthrough therapy designation for pegozafermin in non-alcoholic steatohepatitis
21 September 2023 - Supported by positive data in F2/F3 and F4 NASH patients from the ENLIVEN Phase 2b trial of ...
Posted by Michael Wonder on 21 Sep 2023
The Inflation Reduction Act and access to high cost cardiovascular therapies
20 September 2023 - On August 29, 2023, the Biden-Harris administration announced the first 10 drugs selected for Medicare price ...
Posted by Michael Wonder on 21 Sep 2023
Medicare’s historic prescription drug price negotiations
20 September 2023 - On 29 August 2023, the Biden administration announced the first 10 drugs whose prices will be ...
Posted by Michael Wonder on 21 Sep 2023
Supply and insurance issues snarl fall COVID-19 vaccine campaign for some
20 September 2023 - It has been just over a week since the US FDA and the US Centers for ...
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 21 Sep 2023
Disc Medicine receives FDA fast track designation for MWTX-003 for the treatment of polycythemia vera
20 September 2023 - Disc Medicine today announced that the US FDA has granted fast track designation to MWTX-003 for the ...
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 20 Sep 2023
FDA issues complete response letter for neffy (epinephrine nasal spray) new drug application with request for additional study
19 September 2023 - FDA Advisory Committee (PADAC), held in May 2023, recommended neffy approval based on current data set and ...
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. ...