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© 2021 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2021 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
February 23, 2021
New data shows that the COVID-19 vaccines can be stored at standard freezer temperatures for up to two weeks.
February 22, 2021
The agency issued guidance for developers of vaccines, diagnostics, and therapeutics to address variants of the COVID-19 virus.
February 19, 2021
FDA issued a public statement and press release, along with a sharp warning letter rebuking AcelRx Pharmaceuticals for its messaging on painkiller Dsuvia.
February 17, 2021
The European Medicines Agency announced it has started a review of drugs that contain amfepramone due to concerns that include heart problems and high blood pressure in the lungs.
FDA published recommendations on the use of COVID-19 convalescent plasma or investigational convalescent plasma during the pandemic.
February 15, 2021
The company has pleaded guilty to violating the Federal Food, Drug and Cosmetic Act by failing to provide certain records to FDA investigators and will pay a criminal fine of $30 million, and forfeit an additional $20 million.
Reviews of FDA initiatives and activities recapitulate efforts to assess and approve new drugs, generic drugs, and biologics and strategies for advancing new initiatives.
February 12, 2021
Scientists and policy makers are looking more sharply at the lag in identifying and producing medicines to moderate early infections and to treat seriously ill patients.
February 11, 2021
The EUA is based on positive results from a Phase III trial that showed bamlanivimab and etesevimab together reduced the risk of COVID-19 hospitalizations and death by 70%.
February 10, 2021
The cell therapy will be manufactured for each individual patient at BMS’ immunotherapy manufacturing facility in Bothell, WA, and will be launched across a network of treatment centers.
The selection of a new FDA commissioner has become a contentious issue in Washington, as the White House delays a decision and interest groups line up behind competing candidates.
FDA sent a warning letter to Allay Pharmaceuticals for inadequate written procedures; inadequate out-of-specification testing; inadequate stability testing; and inadequate quality control oversight.
Representatives of industry organizations discuss crucial business, regulatory, science-based issues facing the industry.
February 08, 2021
FDA considers regulatory flexibility to allow the agency and sponsors to adapt and pivot to changes in coronavirus.
February 05, 2021
FDA’s Vaccines and Related Biological Products Advisory Committee will meet on Feb. 26, 2021 to discuss the request for emergency use authorization for Janssen Biotech’s COVID-19 vaccine candidate.
February 02, 2021
FDA puts applications on hold as the agency limits alternative oversight methods.
February 01, 2021
With Democrats controlling Congress and the White House, expectations are high that policy makers will revise certain coverage and payment policies.
January 29, 2021
The European Medicines Agency has recommended granting conditional marketing authorization for AstraZeneca’s COVID-19 vaccine.
FDA published guidance that includes risk-based recommendations for minimizing the potential transmission of COVID-19.
January 25, 2021
Woodcock will serve as acting commissioner of FDA, taking over for Stephen Hahn, FDA’s previous acting commissioner.