Multiple myeloma bispecific antibody granted accelerated approval
Accelerated US approval of a first-in-class bispecific antibody (BsAb) therapy offers a new option for a difficult-to-treat blood cancer.
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Accelerated US approval of a first-in-class bispecific antibody (BsAb) therapy offers a new option for a difficult-to-treat blood cancer.
Several FDA warning letters distributed to pharmaceutical manufacturers in 2023 have warned of numerous corrective and preventive action (CAPA) compliance concerns.
The Scottish Medicines Consortium (SMC)’s acceptance means eligible patients across the UK can now benefit from AstraZeneca's Tezspire (tezepelumab) for severe asthma and Forxiga (dapagliflozin) for chronic heart failure.
The first approved oral treatment that provides rapid symptomatic improvement in postpartum depression (PPD) is expected to be commercially available in the fourth quarter of 2023.
GlobalData has shared research on how the loss of exclusivity of AbbVie’s Humira (adalimumab) is shaping the biosimilars market.
The European Pharmacopoeia (Ph. Eur.) Commission's new European monograph for Cannabis flower will enter into force in July 2024.
In a risk-based framework for implementing a corrective and preventive action (CAPA) process, a continuous improvement approach is proposed as a way to drive higher product quality and improve patient safety.
In this article, Gareth Morgan, a life sciences partner at Pinsent Masons discusses how Leqembi validates the anti-amyloid approach for treating Alzheimer’s, and whether its recent regulatory authorisations could support fast-tracking approvals of other promising Alzheimer’s therapies.
The new COVID-19 vaccine authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) contains an adjuvant and is indicated to be given to patients over 16 years.
2 August 2023 | By Metrohm
This webinar highlights the importance of impurity testing in pharmaceuticals and how ion chromatography can provide excellent sensitivity and selectivity when testing for ionic impurities.
The first new treatment option approved for mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer in decades has been authorised by the US Food and Drug Administration (FDA).
As the next stage of their co-development of vepdegestrant, the Medicines and Healthcare products Regulatory Agency (MHRA) has granted Pfizer and Arvinas its Innovation Passport to advance development of the oestrogen receptor (ER) degrader for ER+HER2- breast cancer.
The European Commission (EC) has approved the first treatment for paediatric patients in the EU to treat seizures associated with CDKL5 deficiency disorder.
A paper has stated that applying the quality by design (QbD) principle during development of bilayer tablets will “help improve product design while also enhancing the quality, safety, and efficacy of drug products”.
Extended EU approval of Soliris to paediatric generalised myasthenia gravis (gMG) patients is based on Phase III data which demonstrated improvement in disease severity through 26 weeks.