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May 03, 2022
FDA’s Office of Compliance has released its 2021 Annual Report, which highlights the agency’s successes in public health.
FDA has issued the final guidance on electronic postmarketing safety reports in a series of guidance documents.
VYDURA has been granted marketing authorization by the European Commission for both acute treatment of migraine and prophylaxis of episodic migraine.
May 02, 2022
Moderna has filed for emergency use authorization of its COVID-19 vaccine for use in young children six months to under six years of age.
A long-running criminal case involving the theft of confidential data from a pharma giant is still unravelling, as more convictions are made.
ENHERTU has been granted breakthrough therapy designation in the US for patients with HER2 low metastatic breast cancer.
FDA has granted regenerative medicine advanced therapy (RMAT) designation to Autolus’ CAR-T cell therapy obe-cel.
April 28, 2022
Societal CDMO has been awarded a new manufacturing and packaging task order agreement by National Cancer Institute.
Thermo Fisher Scientific has expanded its state-of-the-art R&D facility in Hyderabad, India.
April 27, 2022
GeoVax has received a patent for its malaria vaccine from the US Patent and Trademark Office.