GVOKE injection has received regulatory approval from the FDA for the treatment of severe hypoglycemia in patients with diabetes.
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Tepotinib, an investigational therapy for patients with metastatic non-small cell lung cancer has been given Breakthrough Therapy Designation.
Both the intravenous and oral formulations of the antifungal candidate, fosmanogepix, have been granted Fast Track designation by the FDA.
The FDA has approved the first treatment for interstitial lung disease associated with systemic sclerosis or scleroderma.
Generic treatments for blood/bone marrow disorders and acute nausea and vomiting associated with chemotherapy have gained FDA approval.
The Joint Pharmaceutical Analysis Group (JPAG) held a stability meeting at the Royal Society of Chemistry’s headquarters in London earlier this year. Attended by 65 delegates, its focus was on developments in stability testing and evaluation. Here follows a summary of the presentations made at the meeting.
Dr Carsten Hopf and his team are using MALDI imaging in several applications, including drug metabolite and formulation distributions in tissues. This article investigates how this content-rich technique is enabling researchers to gain unique insights to facilitate faster and better drug discovery.
Mahfoozur Rahman and Sarwar Beg explain why we need to change tack from traditional formulation-driven development to a target-based approach in order to increase success with anticancer nanomedicine in the clinic.
Orphan Drug Designation has been granted to the CT053 anti-BCMA CAR-T programme for multiple myeloma treatment.
The Chinese government has announced that medicines containing ingredients from threatened species such as pangolins will no longer be eligible for insurance coverage.
This August saw nine new green lights from the FDA, all small molecules, which makes up a third of the approvals this year.
The examination of ARB drugs by the FDA will be extended to include other generics with similar manufacturing processes to identify impurities.
Expert View: Reaching for the (lyo) stars – the unmatched development and scale-up platform for freeze drying
This article focuses on how formulation data can be utilised to create optimal freeze-drying cycles for a specific product based on the unique process analytical technology (PAT) tools and technologies available in SP Scientific’s LyoStar™ 3, a leading freeze dryer for cycle development.