news
FDA grants regulatory approval for hypoglycemia treatment
GVOKE injection has received regulatory approval from the FDA for the treatment of severe hypoglycemia in patients with diabetes.
List view / Grid view
Formulation
Filter the results
news
Metastatic NSCLC therapy, tepotinib, given Breakthrough Designation
Tepotinib, an investigational therapy for patients with metastatic non-small cell lung cancer has been given Breakthrough Therapy Designation.
news
Fast Track designation granted to fosmanogepix for seven indications
Both the intravenous and oral formulations of the antifungal candidate, fosmanogepix, have been granted Fast Track designation by the FDA.
news
First treatment for patients with rare lung disease approved
The FDA has approved the first treatment for interstitial lung disease associated with systemic sclerosis or scleroderma.
news
Fosaprepitant and Decitabine generics receive FDA approval
Generic treatments for blood/bone marrow disorders and acute nausea and vomiting associated with chemotherapy have gained FDA approval.
article
Developments in stability testing and evaluation
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.
article
Allowable levels of excipients in drug products
Medicinal products typically cannot be manufactured without using excipients. Here, Dave Elder and Fabio Faïs discuss factors for excipient selection and the importance of defined allowable limits to ensure continued product safety.
news
China’s drug bulk-buy programme has been expanded
China has expanded a pilot drug bulk-buying programme to almost the entire country which is adding pressure on pharma companies.
article
Advanced MALDI imaging breaks ground in pharmaceutical research
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.
article
Hitting the target – refining anticancer nanomedicine development
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.
news
Multiple myeloma treatment receives Orphan Drug Designation
Orphan Drug Designation has been granted to the CT053 anti-BCMA CAR-T programme for multiple myeloma treatment.
news
Drugs with ingredients from threatened species not covered by Chinese insurance
The Chinese government has announced that medicines containing ingredients from threatened species such as pangolins will no longer be eligible for insurance coverage.
news
Small molecules dominate FDA drug approvals this month
This August saw nine new green lights from the FDA, all small molecules, which makes up a third of the approvals this year.
news
FDA announces expansion of generic impurity investigation
The examination of ARB drugs by the FDA will be extended to include other generics with similar manufacturing processes to identify impurities.
article
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.