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The U.S. Food and Drug Administration (FDA) is providing this communication to increase awareness of recent updates to the product labeling of capecitabine (Xeloda) and fluorouracil (5-FU) related to risks associated with dihydropyrimidine dehydrogenase (DPD) deficiency. All healthcare providers should be aware of the risks of DPD deficiency, inform patients prior to treatment about the …

Safety labeling update for capecitabine and fluorouracil (5-FU) on risks associated with dihydropyrimidine dehydrogenase (DPD) deficiency Read More »

On January 27, 2026, the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for adults with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).

The European Parliament has agreed proposals for the planned CriticalThe European Parliament has agreed proposals for the planned Critical Medicines Act, which aims to help address medicine shortages in the region, marking a key milestone in its delivery. Medicines Act, which aims to help address medicine shortages in the region, marking a key milestone in …

Europe marks key milestone in adopting Critical Medicines Act Read More »

A recent systematic review and meta-analysis published in The Lancet Obstetrics, Gynaecology, & Women’s Health has found no evidence that using paracetamol at recommended doses during pregnancy increases the risk of autism spectrum disorder, ADHD or intellectual disability in children. This supports the existing evidence and advice that the EMA issued on the use of …

Use of paracetamol during pregnancy unchanged in the EU Read More »

[1/21/2026] The U.S. Food and Drug Administration announced that it will begin accepting applications on February 1, 2026 for the PreCheck Pilot Program. This program will strengthen the domestic pharmaceutical supply chain by increasing regulatory predictability, facilitating the construction of manufacturing sites in the U.S., and streamlining aspects of pharmaceutical manufacturing facility assessments in advance of a specific product application.

On January 20, 2026, the Food and Drug Administration issued a draft guidance for industry that provides recommendations to sponsors about using minimal residual disease (MRD) and complete response (CR) as primary endpoints in trials evaluating drugs and biologics intended to treat patients with multiple myeloma to support approval under the accelerated approval regulations.

EMA and the U.S. Food and Drug Administration (FDA) have jointly identified ten principles for good artificial intelligence (AI) practice in the medicines lifecycle. The principles give broad guidance on AI use in evidence generation and monitoring across all phases of a medicine, from early research and clinical trials to manufacturing and safety monitoring.

In 2025, EMA recommended 104 medicines for marketing authorisation. Of these, 38 had a new active substance which had never been authorised in the European Union (EU) before. This includes medicines representing important innovation or contribution to public health, such as the first medicine to treat non-cystic fibrosis bronchiectasis, a first-in-class treatment to delay the onset of stage …

EMA: Human medicines in 2025 Read More »

The Indian pharma sector has an increasing number of technological priorities underpinning its digital transformation plans, but those ambitions have only partially been realised.

Novel, naturally-derived polymer capsules developed by a team of Japanese researchers could help to advance more sustainable drug delivery options.