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- PMLiVE

Regeneron scores first FDA approval for Ebola antibody treatment

Treatment cut mortality rate in study based in the Democratic Republic of Congo

- PMLiVE

Regeneron seeks US emergency use authorisation for COVID-19 antibody cocktail

If approved, the US government will make initial doses available at no cost

- PMLiVE

FDA publishes new guidelines for COVID-19 vaccine approval

New rules mean a COVID-19 shot is unlikely to be approved pre-election in the US

- PMLiVE

Lilly seeks US emergency approval after posting new data for COVID-19 antibodies

Combination of two antibodies reduced viral load and symptoms of COVID-19

- PMLiVE

Pfizer and BioNTech’s COVID-19 vaccine begins EMA evaluation

Vaccine is the second to undergo EMA's 'rolling review' process after AstraZeneca/Oxford Uni's candidate

- PMLiVE

Moderna CEO says COVID-19 vaccine will be ready for FDA submission in late November

Company will seek emergency use authorisation for experimental vaccine

AstraZeneca AZ

Japan resumes AZ’s COVID-19 vaccine trial, but US study remains on hold

Trials have also resumed in the UK, India, South Africa and Brazil

- PMLiVE

Researchers call on Pfizer to delay COVID-19 vaccine application

Reports that the company could seek regulatory approval in October have raised safety concerns

- PMLiVE

FDA sets January decision date for Xalkori in ALK-positive lymphoma

FDA submission is based on results from ADVL0912 and A8081013 studies

- PMLiVE

Pfizer’s ALK inhibitor Lorbrena hits the mark in head-to-head lung cancer trial

Results showing that the drug is an improvement on Xalkori were released at ESMO 2020 virtual congress

- PMLiVE

BioNTech bolsters COVID-19 vaccine capacity with Novartis deal

Deal will expand production capacity for BNT162b2 candidate

- PMLiVE

American Medical Association calls for COVID-19 vaccine development transparency

Organisation asks FDA to provide transparent information on review plans

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