Aquestive Therapeutics announces FDA issuance of complete response letter for Anaphylm

2 February 2026 - Deficiencies limited to packaging and administration. ...

Read more →

Imfinzi perioperative raegimen recommended for approval in the EU by CHMP for patients with early gastric and gastro-oesophageal cancers

2 February 2026 - Recommendation based on MATTERHORN Phase III trial results which showed a 29% reduction in the risk of ...

Read more →

Call for access to improve quality of life for thyroid cancer survivors

2 February 2026 - A TGA approved drug that prevents kidney failure in thyroid cancer survivors remains inaccessible. ...

Read more →

Chiesi Global Rare Diseases and Protalix BioTherapeutics receive positive CHMP opinion for an additional dosing regimen of 2 mg/kg body weight every four weeks for Elfabrio (pegunigalsidase alfa) in the EU

30 January 2026 - Chiesi Global Rare Diseases and Protalix BioTherapeutics today announced an update on pegunigalsidase alfa. ...

Read more →

Samsung Bioepis to launch Eylea biosimilar Opuviz in Europe

30 January 2026 - Samsung Bioepis said Friday it has reached an agreement with US based firm Regeneron and Germany’s ...

Read more →

Pharming Group receives complete response letter from US FDA for sNDA for Joenja (leniolisib) in children aged 4 to 11 years with APDS

1 February 2026 - Pharming today announced that the US FDA has issued a complete response letter to its supplemental ...

Read more →

Cheaper medicines to help men fight prostate cancer

1 February 2026 - From today, Australians with an aggressive form of prostate cancer will have access to cheaper medicines ...

Read more →

Ultragenyx resubmits biologics license application for UX111 AAV gene therapy to treat Sanfilippo syndrome type A (MPS IIIA) to US FDA

30 January 2026 - Company expects up to six month review period per FDA guidelines. ...

Read more →

New Zealand Pharmaceutical Schedule - 1 February 2026

1 February 2026 - The February 2026 issue of the New Zealand Pharmaceutical Schedule is now available and in effect. ...

Read more →

Sanofi’s Rezurock recommended for EU approval by the CHMP to treat chronic graft vs host disease

30 January 2026 - The EMA’s CHMP has adopted a positive opinion recommending the conditional marketing authorisation of Rezurock (belumosudil) in ...

Read more →

Schedule of Pharmaceutical Benefits - 1 February 2026

1 February 2026 - The February 2026 issue of the Schedule of Pharmaceutical Benefits is out and now in effect. ...

Read more →

Cancer patients gain new hope as Keytruda treatment recommended for subsidy under PBS

31 January 2026 - Lifesaving treatment for cancers that now costs tens of thousands of dollars is set to be cut ...

Read more →

Kygevvi (doxecitine and doxribtimine) recommended for approval in the European Union as treatment for thymidine kinase 2 deficiency

30 January 2026 - – UCB today announced that the CHMP of the EMA adopted a positive opinion recommending granting ...

Read more →

This year drug makers cut prices for several widely used drugs

29 January 2026 - Companies raise prices for most medicines but federal government policy changes drive the reductions. ...

Read more →

Elevar Therapeutics announces FDA acceptance of new drug application resubmission for rivoceranib in combination with camrelizumab as a first-line systemic treatment for unresectable hepatocellular carcinoma

30 January 2026 - Elevar Therapeutics today announced the US FDA accepted the resubmission of a new drug application for its ...

Read more →