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FierceBiotech

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Latest posts

Last updated 17 minutes ago

Implantica finally nabs FDA approval 8 years after EU green light for reflux implant

17 minutes ago

The FDA has signed off on Implantica’s gastroesophageal reflux disease (GERD) implant...

Vacant lab space, shrinking workforce put Mass. in ‘unique position’ for biotech bounceback

about 3 hours ago

A new report on the health of the Massachusetts biotech scene has...

Capricor secures reprieve as FDA extends DMD cell therapy review

about 4 hours ago

The FDA has extended its review of Capricor Therapeutics’ Duchenne muscular dystrophy...

Qiagen appoints new chief executive after 9-month search

about 21 hours ago

Molecular diagnostics specialist Qiagen has a new CEO as Jonathan M. Pratt...

Spruce’s successful FDA talks plant seeds for Q4 filing of ultra-rare disease drug

about 22 hours ago

Spruce Biosciences has taken another step toward filing for FDA approval of...

TME holds onto $1B dream for brain cancer drug as search for partners nears conclusion

about 22 hours ago

TME Pharma’s hunt for a partner for its brain cancer drug is...

Regenxbio gene therapy refiling plan derailed by FDA hold over spine MRI findings

about 24 hours ago

The FDA has put a clinical hold on Regenxbio’s RGX-121 over asymptomatic...

Roche, Eli Lilly net FDA approval for first-of-its-kind Alzheimer’s biomarker blood test

about 24 hours ago

Roche and Eli Lilly have won FDA clearance for their latest Alzheimer’s...

Roche pens $2.5B pact for Hanmi’s clinical-stage obesity drug targeting less-explored mechanism

1 day ago

Roche has taken its obesity strategy into uncharted territory via a $190...

Werewolf transforms into Ambros via reverse merger to support phase 3 push for rare disease drug

4 days ago

Werewolf Therapeutics’ hunt for strategic alternatives has ended. Ambros Therapeutics has agreed...

Chutes & Ladders—Neumora shuffles leadership ahead of IND

4 days ago

Joshua Pinto, Ph.D., has been appointed chief executive officer of Neumora Therapeutics...

Merck-Moderna cancer vaccine win spurs stock jump, speculation of Keytruda-like impact

4 days ago

As the dust settles on phase 3 data that added $45 billion...