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RSS FeedPosted 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 05 Jun 2026
US FDA approves FoundationOne CDx as a companion diagnostic for Itovebi (inavolisib) to identify patients with hormone receptor positive, HER2 negative breast cancer with a PIK3CA mutation
2 June 2026 - Foundation Medicine today announced that it has received approval from the US FDA for FoundationOne CDx ...
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 04 Jun 2026
Biogen’s salanersen receives FDA breakthrough therapy designation for spinal muscular atrophy
4 June 2026 - Biogen announced today that the US FDA has granted salanersen breakthrough therapy designation for the treatment ...
Posted by Michael Wonder on 04 Jun 2026
Verastem Oncology announces US FDA fast track designation for VS-7375, an oral and potential best in class investigational KRAS G12D (ON/OFF) inhibitor for the treatment of KRAS G12D mutated locally advanced or metastatic non-small cell lung cancer
3 June 2026 - Verastem Oncology today announced that the US FDA has granted hast track designation to VS-7375, an oral ...
Posted by Michael Wonder on 03 Jun 2026
Terremoto Biosciences granted FDA fast track designation for TER-2013, an AKT1 selective small molecule inhibitor for breast cancer
3 June 2026 - Terremoto Biosciences today announced that the US FDA granted fast track designation for TER-2013, the Company’s lead ...
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 03 Jun 2026
FDA approves more orphan drugs with specific cancer, paediatric indications over EMA
2 June 2026 - The US FDA is more likely to approve drugs with an orphan designation that were indicated ...
Posted by Michael Wonder on 03 Jun 2026
TearSolutions receives FDA orphan drug and fast track designations for Lacripep in neurotrophic keratitis
2 June 2026 - TearSolutions today announced receiving FDA orphan drug and fast track designations for Lacripep in neurotrophic keratitis. ...
Posted by Michael Wonder on 02 Jun 2026
FDA grants fast track designation to Merakris’ MTX-001
2 June 2026 - Merakris Therapeutics today announced that the US FDA has granted fast track designation to MTX-001, the Company’s ...