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April 08, 2022
Teva has initiated a voluntary nationwide recall of one lot of IDArubicin Hydrochloride Injection USP 5mg/5 mL due to the presence of particulate matter.
UK’s MHRA has issued a positive opinion for the Early Access to Medicines Scheme for radioligand therapy in patients with advanced prostate cancer.
April 06, 2022
FDA has accepted Dupixent for Priority Review in patients aged 12 years and older with eosinophilic esophagitis.
ATMPS Ltd has been granted a patent from the United States Patent and Trademark Office for the use of its Hataali blockchain technology used in personalized medicines.
Legislative proposals set the stage for debate on FDA policies and programs and whether to include some measures in legislation to reauthorize user fees.
FDA has granted an expanded Emergency Use Authorization to Pfizer and BioNTech’s COVID-19 vaccine boosters in individuals aged 50 years and older.
April 05, 2022
ViiV Healthcare announced that FDA has approved Triumeq PD, a dispersible single tablet regimen containing dolutegravir, a once-daily treatment for children living with HIV.
April 02, 2022
In January 2022, Europe started to implement EU-CTR, a new regulatory framework for clinical trials, but what does this mean for pharma clinical research?
Quality metrics and more domestic production aim to avoid supply disruptions and drug shortages.
March 31, 2022
Consumer advocates continue to press for initiatives to lower drug prices by revising or reducing patent protections.