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May 29, 2018
The European Commission has approved Zessly (infliximab), a biosimilar to Johnson & Johnson’s blockbuster Remicade (infliximab).
May 23, 2018
Right-to-Try bill sent to White House for President’s signature after passage by Congress.
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.
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
Barriers impede biosimilar market entry into the United States despite the Biologics Price Competition and Innovation Act.
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.
May 10, 2018
The agency is seeking permanent injunctions to stop two stem cell clinics from marketing stem cell products without FDA approval and for violating cGMP requirements.
May 07, 2018
Pharmaceutical companies should consider what is required for QIDP designation and whether they can use it to extend the protection afforded to their innovative products.