FDA’s ‘misguided’ drug program to be withdrawn

Nov. 24, 2020

By Mari Serebrov

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The latest global regulatory news, changes and updates affecting biopharma, including: Unapproved Drugs Initiative.

BioWorld Regulatory

Free access to BioWorld coronavirus articles

BioWorld

The articles in this collection are from BioWorld’s ongoing coverage of the COVID-19 coronavirus outbreak. Note that we have added three critical tables which are...

Single dose of Pfizer vaccine not strong enough against variants, U.K. study shows

BioWorld

LONDON – A single dose of Pfizer Inc./Biontech SE’s COVID-19 vaccine does not promote a strong enough immune response to provide protection against variants of...

Sinopharm vaccine draws questions after Seychelles COVID-19 case spike

BioWorld

Seychelles has seen rising numbers of COVID-19 cases despite 61% of its population being fully vaccinated as of May 8, calling into question the effectiveness of...

Third time’s the charm: Heron wins FDA nod for non-opioid pain drug

BioWorld

It took a few years and three tries, but Heron Therapeutics Inc. finally got its pain drug, HTX-011, now branded Zynrelef, over the FDA finish line. Even so, the...

Next up, Novavax, after April’s vaccine woes and therapeutic failures

BioWorld

Dangerous blood clots and thrombocytopenia, rare simultaneous side effects seen with two adenoviral vector vaccines from Astrazeneca plc and Johnson & Johnson, as...