FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease

29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...

Read more →

Gilead’s breast cancer treatment Trodelvy passes drug reimbursement panel

7 February 2025 - Gilead's triple negative breast cancer treatment Trodelvy (trastuzumab govitecan) had surmounted a significant hurdle for health ...

Read more →

Nivolumab and ipilimumab for the first-line treatment of patients with metastatic colorectal cancer with high microsatellite instability or mismatch repair deficiency

10 February 2025 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...

Read more →

Biodexa receives US FDA fast track designation for eRapa in familial adenomatous polyposis

10 February 2025 - Biodexa Pharmaceuticals announced today that the US FDA has granted fast track designation for eRapa, a proprietary ...

Read more →

Nektar Therapeutics receives fast track designation for rezpegaldesleukin for the treatment of moderate to severe atopic dermatitis

10 February 2025 - Nektar Therapeutics today announced that the US FDA has granted fast track designation for rezpegaldesleukin for the ...

Read more →

Tempest granted fast track designation from the US FDA for amezalpat to treat patients with hepatocellular carcinoma

10 January 2025 - Tempest Therapeutics today announced that the US FDA has granted fast track designation to amezalpat (TPST-1120), an ...

Read more →

ICER releases draft evidence report on treatment for advanced retinitis pigmentosa

6 February 2025 - Public comment period now open until 6 March 2025; requests to make oral comment during public ...

Read more →

ICER publishes evidence report on treatment for acute pain

5 February 2025 - Current evidence suggests that suzetrigine may provide a net health benefit when compared to no systemic ...

Read more →

February 2025 decisions

10 February 2025 - The SMC, which advises on newly licensed medicines for use by NHSScotland, has today published advice ...

Read more →

Big pharma steps up push for taxpayer-funded weight loss drugs

9 February 2025 - Novo Nordisk and Eli Lilly have asked the federal government to list their blockbuster weight-loss drugs ...

Read more →

Albanese Labor Government strengthening Medicare with over $500 million for women's health

9 February 2025 - The Albanese Labor Government is building Australia’s future and strengthening Medicare, today announcing $573.3 million to deliver ...

Read more →

Bio-Thera Solutions announces regulatory filing acceptance for BAT2506, a proposed biosimilar to Simponi, in the European Union

7 February 2025 - The BAT2506 marketing authorisation application is based on a robust analytical, non-clinical and clinical data package comparing ...

Read more →

US FDA approves Emblaveo (aztreonam and avibactam) for the treatment of adults with complicated intra-abdominal infections with limited or no treatment options

7 February 2025 - Emblaveo is the first and only monobactam/β-lactamase inhibitor combination antibiotic therapy approved by the US FDA to ...

Read more →

FDA grants priority review to Insmed's brensocatib for treatment of bronchiectasis

6 February 2025 - Brensocatib would be the first and only available treatment for bronchiectasis and first DPP1 inhibitor, if ...

Read more →

Gradalis secures FDA regenerative medicine advanced therapy designation for Vigil (gemogenovatucel-T): an investigational personalised immunotherapy for advanced ovarian cancer

5 February 2025 - Recognising clinical evidence from the Phase 2b VITAL Study of Vigil in homologous recombination proficient patients with ...

Read more →

Bracco Imaging receives FDA fast track designation for BR55, ultrasound molecular imaging agent for the detection of active bowel inflammation in Crohn's disease

6 February 2025 - BR55 is a contrast agent for ultrasound imaging targeted at a molecule expressed in angiogenesis, i.e., the ...

Read more →