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FDA approval sought for frontline Tevimbra (tislelizumab) in locally advanced or metastatic esophageal squamous cell carcinoma – BeiGene

Written by | 27 Sep 2023

The FDA has accepted for review a biologics license application (BLA) seeking the approval of tislelizumab (Tevimbra) for use in the frontline treatment of patients with unresectable, recurrent,… read more.

CHMP positive for Finlee + trametinib for the treatment of low and high grade glioma – Novartis

Written by | 26 Sep 2023

On 14 September 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product… read more.

FDA grants priority review to application for Keytruda + concurrent chemoradiotherapy, as treatment for newly diagnosed high-risk locally advanced cervical cancer – Merck Inc

Written by | 25 Sep 2023

Merck Inc., known as MSD outside of the United States and Canada, announced the FDA has accepted for priority review a new supplemental Biologics License Application (sBLA) seeking… read more.

European Commission authorises Apretude (cabotegravir long-acting and tablets) for HIV prevention – Viiv HealthCare

Written by | 24 Sep 2023

GSK plc announced that ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders announced that the European Commission has authorised… read more.

Pfizer Japan files 20-valent pneumococcal vaccine for older adults and individuals at high risk of contracting an infectious disease caused by pneumococcus

Written by | 23 Sep 2023

Pfizer has filed Apexxnar, its 20-valent pneumococcal conjugate vaccine in Japan for the prevention of pneumococcal infection in older adults and individuals at a high risk of contracting… read more.

Quizartinib recommended for approval in EU by CHMP for patients with newly diagnosed FLT3-ITD positive AML – Daiichi Sankyo

Written by | 22 Sep 2023

Daiichi Sankyo announced that quizartinib has been recommended for approval in the European Union (EU) in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy,… read more.

Xtandi accepted for EMA review for earlier type of prostate cancer – Astellas

Written by | 21 Sep 2023

Astellas announced that the European Medicines Agency (EMA) has validated its Type II variation for Xtandi (enzalutamide) for the treatment of patients with non-metastatic hormone-sensitive prostate cancer (nmHSPC… read more.

Ojjaara (momelotinib) approved by FDA to treat intermediate or high-risk myelofibrosis – GSK

Written by | 20 Sep 2023

GSK plc announced that the FDA has approved Ojjaara (momelotinib) for the treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis (post-polycythaemia vera and post-essential… read more.

CHMP positive for Spikevax, the updated COVID-19 vaccine containing spike proteins for the XBB.1.5 sublineage of SARS-CoV-2 for active immunization to prevent COVID-19 – Moderna

Written by | 19 Sep 2023

Moderna, Inc. announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization for Spikevax, its… read more.

Tagrisso plus chemotherapy extended median progression-free survival by nearly 9 months in EGFR-mutated advanced lung cancer in FLAURA2 phase III trial – AstraZeneca

Written by | 18 Sep 2023

Positive results from the FLAURA2 Phase III trial showed AstraZeneca’s Tagrisso (osimertinib) in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS),… read more.

MAA is submitted to the European Medicines Agency seeking approval of erdafitinib for the treatment of patients with locally advanced or metastatic urothelial cancer with susceptible FGFR alterations – Janssen Pharmaceutical

Written by | 17 Sep 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of erdafitinib for… read more.

Skyrizi met all primary and secondary endpoints versus Stelara in head-to-head study in Crohn’s disease – AbbVie

Written by | 16 Sep 2023

AbbVie announced top-line results from the Phase III SEQUENCE clinical trial evaluating risankizumab (Skyrizi, 600 mg intravenous [IV] induction at week 0, 4 and 8 and 360 mg… read more.

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