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Nearly a year after surprise rejection, Immunomedics returns to FDA

6 days ago

Cell, gene therapy manufacturing takes center stage as Novartis, Amazon join forces

6 days ago

FDA will convene adcomm for Bristol-Myers' Reblozyl in MDS; FDA grants 'orphan' tags to a trio of drugs

6 days ago

Merck in $1.3B showdown with insurers over 2017 ransomware attack — Bloomberg

6 days ago

Eager to tout pivotal win, Omeros however keeps key parameters shrouded

6 days ago

As it shops for new deals, Akcea hires former GSK exec as COO

6 days ago

In a win for industry, Trump administration issues scathing review of Pelosi drug pricing bill

6 days ago

An old, controversial Pfizer drug shows mid-stage efficacy against narcolepsy

6 days ago

Roche moves deeper into Merck territory with Tecentriq/chemo OK in frontline NSCLC

6 days ago

Antibody strategy to augment versatile immune cells sparks investment in French biotech

Last week

Biogen comes under renewed fire as a leading Alzheimer's expert raises serious questions about the aducanumab data

Last week

RAPT signs on with struggling Hanmi for Asian entrance of cancer therapy aimed at 'charged tumors'

Last week

Ardelyx reaches the 'capstone' in their third-straight positive PhIII – but many questions still linger

Last week

AbbVie picks first Alzheimer's, Parkinson's targets in Mission pact; Amarin files for Vascepa OK in Europe

Last week

Biogen boasts PhII win in lupus — will anyone turn their head from Alzheimer's to notice?

Last week

Struggling Adaptimmune gets a boost from the FDA as T cell cancer drug wins an inside track at the agency

Last week

Senate committee backs Stephen Hahn as the next FDA commissioner

Last week

On the heels of $225M royalty deal, Kodiak shoots for $250M raise to fund pivotal programs of its Eylea slayer

Last week

FDA ushers Merck's star cancer drug Keytruda toward another key checkpoint

Last week

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Last week

Publisher's note

FDA finalizes guidance on adaptive trial designs

Last week

Astellas snags a gene therapy upstart with $3B buyout bid — inspiring forecasts of more M&A ahead

Last week

FDA to Lexicon: Yeah, that's still gonna be a no from us

Last week

Incyte nabs priority review for bile duct cancer drug; Temasek shows interest in another Woodford darling — report

Last week

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