Bristol Myers Squibb receives positive CHMP opinion for CAR T cell therapy Breyanzi (lisocabtagene maraleucel) for relapsed or refractory DLBCL, PMBCL and FL3B

28 January 2022 - Recommendation for approval based on results from TRANSCEND NHL 001, the largest pivotal trial of patients ...

Read more →

Regeneron and Sanofi provide regulatory update on Libtayo (cemiplimab-rwlc) in advanced cervical cancer

28 January 2022 - Regeneron Pharmaceuticals and Sanofi today announced the voluntary withdrawal of the supplemental biologics license application for Libtayo ...

Read more →

FDA grants breakthrough therapy designation for Dizal Pharmaceutical's DZD9008 in patients with locally advanced or metastatic non-small cell lung cancer harbouring EGFR Exon 20 insertion

27 January 2022 - Breakthrough therapy designation further demonstrates excellent clinical profile of DZD9008 (sunvozertinib). ...

Read more →

TGA approves Tepmetko for patients with non-small-cell lung cancer

27 January 2022 - Tepotinib (Tepmetko) has provisional approval in Australia for the treatment of adult patients with locally advanced or ...

Read more →

Lantern Pharma receives rare paediatric disease and orphan drug designations for LP-184 for the treatment of atypical teratoid rhabdoid tumour

24 January 2022 - Lantern Pharma today announced that the U.S. FDA has granted both rare paediatric disease designation and orphan ...

Read more →

Immunocore announces FDA approval of Kimmtrak (tebentafusp-tebn) for the treatment of unresectable or metastatic uveal melanoma

26 January 2022 - Kimmtrak is the first T cell receptor therapeutic to receive regulatory approval. ...

Read more →

Former bowel cancer patient calls for NZ to fund drug she says saved her life

26 January 2022 - A woman with bowel cancer who was told she may have two years to live says ...

Read more →

Incyte provides update on parsaclisib and MCLA-145

25 January 2022 - Incyte today announced updates regarding the clinical development of parsaclisib, the Company’s next-generation oral inhibitor of ...

Read more →

Senhwa’s pidnarulex receives US FDA fast track designation for the treatment of solid tumours with BRCA1/2, PALB2 and other HR gene mutations

24 January 2022 - Senhwa Biosciences announced today that the US FDA has granted fast track designation for Pidnarulex, a first ...

Read more →

Oncopeptides withdraws withdrawal of first marketed drug

24 January 2022 - Swedish pharmaceutical company Oncopeptides announced that it has contacted the U.S FDA and rescinded its 22 ...

Read more →

Breast cancer patients in Scotland are set to receive tumour blasting wonder drug that starts working in weeks - sparking hopes of a wider rollout for NHS patients across the rest of the UK

23 January 2022 - A breast cancer drug that can melt away tumours in weeks has been given the green ...

Read more →

People with chronic myeloid leukaemia granted early access to Novartis’ investigational treatment

24 January 2022 - The Medicine and Healthcare products Regulatory Agency grants positive scientific opinion on use of asciminib as 3rd-line ...

Read more →

Immunotherapy with blinatumomab improves the chances of survival in very rare childhood blood cancer

20 January 2022 - The Federal Joint Committee (G-BA) today classified the additional benefit of the active ingredient blinatumomab as significant ...

Read more →

Lumakras (sotorasib) receives approval in Japan for patients with KRAS G12C mutated advanced non-small cell lung cancer

20 January 2022 - Approval based on pivotal CodeBreaK 100 data demonstrating durable responses and a favourable benefit-risk profile with Lumakras. ...

Read more →

Bristol Myers Squibb receives approval for Abecma (idecabtagene vicleucel), the first CAR T therapy approved for the treatment of multiple myeloma in Japan

20 January 2022 - Bristol-Myers Squibb today announced that Japan’s Ministry of Health, Labour and Welfare has approved Abecma (idecabtagene ...

Read more →