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April 01, 2020
Understanding European GMPs and new rules from China for excipients are crucial for formulating solid-dosage drugs.
March 30, 2020
The bill includes multiple less-noticed provisions to bolster healthcare programs and to advance the development of new treatments and preventives to combat the virus.
March 27, 2020
AstraZeneca has announced that it has achieved approval in Japan for Lokelma (sodium zirconium cyclosilicate) for the treatment of patients with hyperkalemia (elevated blood potassium levels).
Noting traditional clinical trials for COVID-19 convalescent plasma will take time, FDA is allowing physicians to submit requests for single-patient emergency INDs.
March 25, 2020
Bayer, Novartis, Mylan, Teva, report that they are working on supply.
In light of the current COVID-19 pandemic, the agencies co-chaired the first global regulators meeting to facilitate development of vaccines against SARS-CoV-2, which causes COVID-19.
March 24, 2020
FDA officials are rolling out guidance and support for researchers striving to assess potential treatments for COVID-19 while the agency tries to object to premature optimism and regain public credibility.
March 23, 2020
FDA has been working closely with other government agencies and academic centers that are investigating the use of the drug chloroquine to determine whether it can be used to treat patients with mild-to-moderate COVID-19.
March 20, 2020
FDA is offering advice and added flexibility to help sponsors adjust ongoing and planned clinical research programs during the COVID-19 outbreak.
March 18, 2020
The Pharmacovigilance Risk Assessment Committee (PRAC) of EMA has recommended that women stop taking 5-mg ulipristal acetate (Esmya and generic medicines) for the treatment of uterine fibroids while a safety review into potential liver injury risk is performed.