Health Canada approves Keytruda SC, a subcutaneous formulation of pembrolizumab across multiple cancer indications

17 February 2026 - Merck announced today that Health Canada has approved Keytruda SC (pembrolizumab injection), a new subcutaneous formulation of ...

Read more →

PHARMAC proposes funding new treatments that could transform early care for people with chronic lymphocytic leukaemia, a type of blood cancer

18 February 2026 - People in New Zealand living with chronic lymphocytic leukaemia could soon benefit from funded access to ...

Read more →

FDA approves Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) as the only EGFR-targeted therapy that can be administered once a month

17 February 2026 - Johnson & Johnson today announced the US FDA has approved a new, simplified monthly dosing schedule for ...

Read more →

US FDA accepts Bristol Myers Squibb's new drug application for iberdomide in patients with relapsed or refractory multiple myeloma

17 February 2026 - Bristol Myers Squibb today announced that the US FDA has accepted a new drug application for ...

Read more →

Agilent receives FDA approval for PD-L1 IHC 22C3 pharmDx in epithelial ovarian, fallopian tube, or primary peritoneal carcinoma

11 February 2026 - Approval expands PD-L1 testing to support treatment decisions with Keytruda (pembrolizumab). ...

Read more →

Lifesaving drugs blocked by Australia’s ‘broken’ approvals process

12 February 2026 - Australia’s processes for funding vital medicines is recognised as broken. Lives are on the line as patients, ...

Read more →

FGFR4 inhibitor irpagratinib granted FDA fast track designation for HCC patients

10 February 2026 - Abbisko Therapeutics announced that the US FDA has granted fast track designation to irpagratinib (ABSK-011), a ...

Read more →

FDA approves pembrolizumab with paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma

10 February 2026 - Today, the FDA approved pembrolizumab (Keytruda, Merck) as well as pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, ...

Read more →

Krystal Biotech announces RMAT designation granted by FDA to KB707 for the treatment of advanced or metastatic non-small cell lung cancer

9 February 2026 - Krystal Biotech announced today that the US FDA granted regenerative medicine advanced therapy designation to KB707, ...

Read more →

FDA approves label update for Kite’s Yescarta for relapsed/refractory primary central nervous system lymphoma

6 February 2026 - FDA approves label update for Kite’s Yescarta for relapsed/refractory primary central nervous system lymphoma. ...

Read more →

Kisqali receives positive draft recommendation from Canada's Drug Agency for all eligible early breast cancer patients at high risk of recurrence

6 February 2026 - The draft recommendation for Kisqali (ribociclib tablets) from Canada's Drug Agency (CDA-AMC) supports public reimbursement for hormone ...

Read more →

PHARMAC proposes wider access to a treatment for people with a rare blood cancer

4 February 2026 - People in New Zealand living with a rare type of blood cancer, systemic anaplastic large cell ...

Read more →

Oncolytics Biotech receives FDA fast track designation for pelareorep in second-line KRAS mutant MSS metastatic colorectal cancer

4 February 2026 - Pelareorep now has fast track designation for two gastro-intestinal cancers, solidifying its potential as an immunotherapeutic ...

Read more →

Leads Biolabs' GPRC5D/CD3 bispecific T-cell engager LBL-034 earns FDA fast track designation—accelerating launch of potential best in class therapy for relapsed/refractory multiple myeloma

27 January 2026 - Nanjing Leads Biolabs today announced that its key investigational asset LBL-034, a GPRC5D/CD3 bi-specific antibody with a ...

Read more →

OS Therapies initiates US FDA BLA filing for OST-HER2 in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma

2 February 2026 - OS Therapies today announced that it has formally initiated a biologics license application submission to the US ...

Read more →