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JP Morgan

JPM2023: Breakthroughs await, but so do roadblocks

Editor-in-chief Jonah Comstock lays out a few of the most potent threads he heard in the conference centres, hotel rooms, and rain-soaked Lyfts of San Francisco.

News

Janssen makes EMA marketing application for talquetamab for ...

The Janssen Pharmaceutical Companies of Johnson & Johnson have submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA), seeking approval of talqueta

News

FDA "collaborated" with Biogen on Aduhelm approval, says inq...

The FDA's interactions with Biogen in the build-up to last year's controversial approval of Alzheimer's disease therapy Aduhelm have been described as "inappropriate" and "atypical" in a co

News

Congress delivers festive PIE to patients, speeding access t...

After years of preparation, the US Congress passed the Pre-approval Information Exchange (PIE) Act just ahead of the Christmas break, legislation that will allow medical payers and the FDA

News

RSV vaccine race in balance as FDA sets May date for Pfizer ...

The FDA has started its review of Pfizer’s respiratory syncytial virus (RSV) vaccine for older adults, fast-tracking the biologics license application (BLA) with a decision due in May 2023.

News

Pfizer, BioNTech submit to FDA for Covid vaccine in under 5s

Pfizer and BioNTech have announced that they have submitted an Emergency Use Authorisation (EUA) to the US Food and Drug Administration (FDA) for their Omicron BA.4/BA.5-adapted bivalent CO

JPM2023: Breakthroughs await, but so do roadblocks

Janssen makes EMA marketing application for talquetamab for ...

FDA "collaborated" with Biogen on Aduhelm approval, says inq...

Congress delivers festive PIE to patients, speeding access t...

RSV vaccine race in balance as FDA sets May date for Pfizer ...

Pfizer, BioNTech submit to FDA for Covid vaccine in under 5s

Lower COVID sales weigh on AZ in fourth quarter

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