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FDA reports unsanitary practices at Emergent Covid-19 vaccine plant pharmaceutical-technology
April 23, 2021
The US Food and Drug Administration (FDA) has released a report citing several unsanitary practices including peeling paint, shoddy clean-ups and poorly trained staff at the Baltimore plant owned by Emergent Biosolutions (EBS), which is producing ...
Caplin Steriles gets USFDA approval for Neostigmine Methylsulfate Injection expresspharma
April 23, 2021
Caplin Steriles, a subsidiary company of Caplin Point Laboratories, has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Neostigmine Methylsulfate Injection ...
KemPharm Receives $10M Milestone for FDA Approval of Azstarys contractpharma
April 23, 2021
KemPharm Inc., a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, has confirmed receipt of a regulatory milestone payment of $10 million for the FDA approval of Azstarys in accordance with the recently ...
FDA halts COVID-19 vaccine production at Emergent facility europeanpharmaceuticalreview
April 22, 2021
The FDA has requested Emergent’s Bayview plant be closed and vaccine production halted while the agency investigates potential good manufacturing practice (GMP) violations.
Breakthrough designation granted for Amgen’s bemarituzumab pharmatimes
April 21, 2021
Amgen’s investigational medicine bemarituzumab has received a breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA).
Agenus Submits Balstilimab Biologics License Application to the U.S. FDA for Patients with Recurrent or Metastatic Cervical Cancer americanpharmaceuticalreview
April 20, 2021
Agenus Inc., an immuno-oncology company with an extensive pipeline of agents which includes checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate immune response to cancers and infections, announced the submission of a ...
FDA revokes emergency use authorization for monoclonal antibody Bamlanivimab worldpharmanews
April 19, 2021
The U.S. Food and Drug Administration revoked the emergency use authorization (EUA) that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used for the treatment of mild-to-moderate COVID-19 in ...
FDA, CDC calling to halt distribution of J&J vaccine is a blow to global vaccine effort: GlobalData expresspharma
April 16, 2021
Following the news that the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) released a joint statement calling for an immediate pause to the use of the Johnson & Johnson (J&J) vaccine.
Gilead gets US FDA Accelerated Approval for Trodelvy to treat metastatic urothelial cancer expresspharma
April 15, 2021
Gilead Sciences announced that the US Food and Drug Administration (FDA) has granted accelerated approval of Trodelvy (sacituzumab govitecan-hziy) for use in adult patients with locally advanced or metastatic urothelial cancer (UC) who have previously ...
Joint CDC and FDA statement on Johnson & Johnson COVID-19 vaccine worldpharmanews
April 14, 2021
As of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen) vaccine have been administered in the U.S. CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after ...

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