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RSS FeedPosted by Michael Wonder on 14 Jun 2026
Camurus provides regulatory update on the US NDA for CAM2029 (Oclaiz) in acromegaly
10 June 2026 - Camurus today announced that the US FDA has issued a complete response letter regarding the new ...
Posted by Michael Wonder on 14 Jun 2026
Sanofi’s Tzield approved in the US as the first disease-modifying therapy for patients recently diagnosed with stage 3 type 1 diabetes
12 June 2026 - Approval based on the PROTECT phase 3 study and additional data from the global clinical development program ...
Posted by Michael Wonder on 13 Jun 2026
FDA approves capivasertib with abiraterone and prednisone for PTEN deficient androgen pathway modulation-naïve or -sensitive prostate cancer
12 June 2026 - Today, the FDA approved capivasertib (Truqap, AstraZeneca) in combination with abiraterone and prednisone for adults with ...
Posted by Michael Wonder on 12 Jun 2026
FDA grants priority review for Genentech’s Tecentriq for a certain type of stage III colon cancer
10 June 2026 - Genentech announced today that the US FDA has accepted the company’s supplemental biologics license application filing for ...
Posted by Michael Wonder on 12 Jun 2026
FDA approves belzutifan with pembrolizumab for adjuvant treatment of renal cell carcinoma
12 June 2026 - Today, the FDA approved belzutifan (Welireg, Merck) in combination with pembrolizumab (Keytruda, Merck) or pembrolizumab and ...
Posted by Michael Wonder on 12 Jun 2026
Truqap combination approved in the US as first and only targeted treatment for PTEN-deficient metastatic hormone-sensitive prostate cancer
12 June 2026 - Based on results of CAPItello-281 which prospectively defined PTEN deficient disease and showed Truqap combination reduced risk ...
Posted 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). ...