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May 15, 2020
A temporary restraining order was entered against Xephyr LLC, doing business as N-Ergetics requiring the company to immediately stop distributing colloidal silver products.
Regulators have exaggerated expectations for simulated media fills.
May 14, 2020
The CHMP has issued a recommendation that the compassionate use of remdesivir be expanded in the treatment of more patients with severe COVID-19 symptoms.
May 12, 2020
Some observers fear that political interference in the process may erode confidence in the scientific basis for FDA regulatory decisions.
May 08, 2020
The agency is responding to companies promoting and selling medical products that claim, but are unproven, to prevent or treat COVID-19.
May 07, 2020
A high-level meeting on COVID-19 policies, organized by EMA under the auspice of the International Coalition of Medicines Regulatory Authorities (ICMRA), has brought together global regulators to ensure a coordinated pandemic response.
AbbVie and Allergan have satisfied all required antitrust clearances for the acquisition.
Tabrecta is approved to specifically target metastatic non-small cell lung cancer with a mutation that leads to MET exon 14 skipping (METex14).
May 06, 2020
EMA's Committee for Medicinal Products for Human Use has recommended that all ranitidine medicines be suspended within the European Union as a result of the presence of low levels of NDMA.
May 02, 2020
Industry must never become complacent about the safety of drug products and should seek to continually perform surveillance even if the drug is well-established.