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May 23, 2018
Right-to-Try bill sent to White House for President’s signature after passage by Congress.
The agency issued guidance on over-the-counter topical drug products that address maximal usage trials.
The new drug offers rapid and sustained control of patients’ potassium levels.
May 21, 2018
The agency approved Amgen and Novartis’ Aimovig (erenumab-aooe), the first FDA-approved preventive treatment for migraine in adults.
May 17, 2018
The FDA commissioner released a statement expressing the agency’s plan to address tactics used by pharma companies to delay generic-drug competition.
Representatives from the two pharmacopeias held a symposium on European and Indian legislation and regulatory requirements regarding the quality of drugs.
May 16, 2018
The agency has approved Retacrit (epoetin alfa-epbx) by Pfizer’s Hospira, which is a biosimilar to Amgen’s anemia drug, Epogen/Procrit (epoetin alfa).
May 14, 2018
President Donald Trump announced his strategy for making prescription medicines more affordable and accessible in the United States.
FDA sent a warning letter to Goran Pharma Private Limited citing inadequate quality control violations.
May 11, 2018
The use of more targeted therapies is expanding as the public gains access to low-cost genetic testing, and more advanced computer systems are offering data from healthcare systems.