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RSS FeedPosted by Michael Wonder on 10 Jun 2026
FDA approves Lilly's Ebglyss (lebrikizumab-lbkz) for one maintenance dose every eight weeks in patients with moderate to severe atopic dermatitis
9 June 2026 - Eli Lilly announced today that the US FDA approved a regimen of one maintenance dose every eight ...
Posted by Michael Wonder on 09 Jun 2026
US FDA accepts Takeda's application for intravenous Entyvio (vedolizumab) in paediatric ulcerative colitis and Crohn's disease
9 June 2026 - Takeda today announced the US FDA has accepted for review its supplemental biologics license application for intravenous ...
Posted by Michael Wonder on 09 Jun 2026
Alvotech announces FDA acceptance of biologics license application for AVT16, a proposed interchangeable biosimilar to Entyvio
8 June 2026 - Alvotech today announced that the US FDA has accepted for review a biologics license application for ...
Posted by Michael Wonder on 08 Jun 2026
US FDA approves Pfizer’s Hympavzi for the treatment of two additional haemophilia A or B patient populations with significant medical need
8 June 2026 - Pfizer today announced that the US FDA has approved an expanded indication for Hympavzi (marstacimab-hncq) to include ...
Posted by Michael Wonder on 07 Jun 2026
Boan Biotech submits a biologics license application for two denosumab biosimilars in the US
29 May 2026 - Boan Biotech announced today that it has submitted a biologics license application to the US FDA for ...
Posted by Michael Wonder on 06 Jun 2026
Xspray Pharma receives CRL from US FDA for Nilopki
4 June 2026 - Xspray Pharma has received a complete response letter from the US FDA for its new drug application ...
Posted by Michael Wonder on 04 Jun 2026
Pharming announces US FDA acceptance of sNDA resubmission for Joenja (leniolisib) to treat children aged 4 to 11 years with APDS
4 June 2026 - Pharming today announced that the US FDA has accepted its resubmitted supplemental new drug application seeking approval ...
Posted by Michael Wonder on 03 Jun 2026
Cingulate receives complete response letter from FDA for CTx-1301
2 June 2026 - Cingulate today announced that the US FDA has issued a complete response letter for its new ...
Posted by Michael Wonder on 03 Jun 2026
Agilent receives FDA approval for expanded use of PD-L1 IHC 22C3 pharmDx on Dako Omnis in oesophageal squamous cell carcinoma, triple negative breast cancer, cervical cancer and gastric or gastro-oesophageal junction adenocarcinoma
2 June 2026 - Approval expands PD-L1 testing onto an automated workflow to support treatment decisions with Keytruda (pembrolizumab). ...
Posted by Michael Wonder on 02 Jun 2026
FDA accepts new drug application for Roche’s giredestrant in oestrogen receptor positive early-stage breast cancer, the first and only oral SERD with positive phase III results in the curative setting
2 June 2026 - Roche announced today that the US FDA has accepted the company’s new drug application under priority review ...
Posted by Michael Wonder on 02 Jun 2026
Vertex announces US FDA acceptance of biologics license application for accelerated approval of povetacicept in IgA nephropathy
1 June 2026 - 2026-- Vertex Pharmaceuticals today announced the US FDA has accepted its biologics license application submission for ...
Posted by Michael Wonder on 02 Jun 2026
Zenas BioPharma announces submission of biologics license application to US FDA for obexelimab in IgG4-RD
28 May 2026 - BLA submission based on positive results from Phase 3 INDIGO trial. ...
Posted by Michael Wonder on 02 Jun 2026
US FDA accepts for priority review Bristol Myers Squibb’s supplemental new drug application for Camzyos (mavacamten) to treat adolescents with symptomatic obstructive hypertrophic Cardiomyopathy
1 June 2026 - Bristol Myers Squibb today announced the US FDA accepted a supplemental new drug application for Camzyos ...
Posted by Michael Wonder on 02 Jun 2026
PolyPid completes new drug application submission to FDA for D-PLEX₁₀₀
1 June 2026 - PolyPid today announced the successful completion of its new drug application submission on a rolling review basis ...
Posted by Michael Wonder on 01 Jun 2026
Shionogi announces FDA approval of Xocova (ensitrelvir), the first and only oral option to help prevent COVID-19 following exposure
1 June 2026 - Approval is based on SCORPIO-PEP, the only Phase 3 study of an oral antiviral to meet the ...