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On 9 December 2024, GSK announced that the US FDA has accepted for review data to support a new indication for the use of Nucala® (mepolizumab) as an add-on maintenance treatment for patients with chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype. ...

On 8 December 2024, Johnson & Johnson (J&J) announced data showing that Darzalex Faspro® (daratumumab and hyaluronidase-fihj) )-based regimens improve overall and sustained minimal residual disease negativity rates and progression-free survival in patients with newl...

On 8 December 2024, Johnson & Johnson (J&J) announced data from the Phase 3 AQUILA study (NCT03301220) showing a 51 percent reduction in the risk of progression to active multiple myeloma for patients with high-risk smoldering multiple myeloma when treated with Darz...

On 6 December 2024, Novo Holdings A/S, Novo Nordisk’s holding company, announced that the European Commission approved its acquisition of the US global contract development and manufacturing organisation, Catalent, Inc.

The acquisition is expected to be completed tow...

On 6 December 2024, New Zealand’s Pharmac announced that it would, in partnership with AstraZeneca, be providing funding to four more cancer treatments and respiratory medicines including AstraZeneca/Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan) for people with HER2-po...

In October 2024, we reported that Novo Nordisk requested the US FDA to include semaglutide in the FDA’s Demonstrable Difficulties for Compounding (DDC) list, citing safety concerns.

In a response made available on 26 November 2024, the US Alliance for Pharmacy Compou...

On 6 December 2024, AstraZeneca announced that its sBLA for Imfinzi® (durvalumab) has been granted Priority Review by the US FDA for the treatment of patients with muscle-invasive bladder cancer (MIBC).

This follows AstraZeneca’s announcement in August 2024 that the ...

At a meeting on 5 December 2024, the Subject Expert Committee SEC functional under the Central Drug Standard Control Organisation (CDSCO) approved Zydus’ Sigrima®, biosimilar to Roche’s Perjeta® (pertuzumab), in patients with HER2-positive metastatic and early breast cancer...

On 5 December 2024, Jazz Pharmaceuticals’ announced that Ziihera® (zanidatamab-hrii) 50 mg/mL for injection for intravenous use has been recommended by the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology as a category 2A treatment opt...

On 5 December 2024, the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) approved BeiGene’s Tevimbra® (Tislelizumab) for the following indications:

as monotherapy for the treatment of adult patients with unresectable, recurrent, locally advanced...