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Novartis buys Mallinckrodt's FDA voucher for $100M but remains mum on where to use its 7th PRV

3 years ago

PI3K inhibitor hit with an increased death risk warning from FDA after final trial results emerge

3 years ago

GSK selects ‘thoughtful’ multiple myeloma program for inaugural ‘Think Tank’ challenge win

3 years ago

New research argues drug pricing negotiations would stymie innovation, as Democrats fight for revised proposal

3 years ago

ICMRA to launch several regulatory pilot programs centered around manufacturing inspections

3 years ago

Manufacturing roundup: Terumo BCT partners with BioBridge subsidiary to manufacture cell and gene therapies; WuXi STA ...

3 years ago

Novartis to resume the production of two radioligand therapies after resolving quality issues

3 years ago

9 Meters Biopharma and Cara Therapeutics tout mid-stage data for gastrointestinal, pruritus studies

3 years ago

Another biotech grabs the axe, chopping R&D in a major reorganization as drug sales disappoint

3 years ago

Novartis, BeiGene lay out frontline PhIII data for PD-1 drug as second-line PDUFA date looms

3 years ago

Roche, Pfizer top list of ESG leaders in patient groups' view, but many still think pharmas can do better

3 years ago

Plotting a comeback after 2016 flop, Seres to raise $100M to prep C. difficile program for launch

3 years ago

Scoop: A small gene therapy biotech, flush with ex-Sarepta and bluebird leaders, guts CMC

3 years ago

What bear market? Blueprint lines up $1.25B to expand labels, maybe tack on more drugs

3 years ago

FDA slaps warning letter on Minnesota API facility after employee destroys cleaning log

3 years ago

Little biotech makes deep cuts as it struggles to get narcolepsy drug approved amid months of regulatory limbo

3 years ago

As booster season awaits, US re-ups supply of Pfizer Covid-19 vaccine with new $3.2B deal

3 years ago

Fujifilm invests another $1.6B into its CDMO arm to upgrade facillites in the US and Europe

3 years ago

FDA sidelines Paul Hudson's $3.7B MS drug after establishing link to liver damage

3 years ago

Angion, still reeling from past defeats, scraps a PhII kidney disease study after 'unexpected' safety event

3 years ago

Catching up with Bristol Myers and Merck, AstraZeneca declares neoadjuvant win for PD-L1/chemo combo

3 years ago

Gilead scores a $33M settlement from its campaign against ‘colossal financial fraud’

3 years ago

HHS to distribute 1.6M monkeypox vaccine doses this year

3 years ago

Novo Nordisk spells out the details behind a PhII NASH failure which reshaped its clinical plans

3 years ago

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