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Approval · news · pharmadog
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News · Approval
646
stories
17d
Opinion: I’m using not-FDA-approved software to manage my diabetes. I’ve never felt better
stat
17d
Latigo laces up for $247M IPO to fund non-opioid pain drug rival to Vertex’s Journavx
fiercebiotech
17d
Recon: Lilly to broaden expanded access for unapproved obesity drug; Jazz to withdraw second-line SCLC indication for Zepzelca
raps
18d
FDA expands Pluvicto label, making it available to most metastatic prostate cancer patients
endpoints
18d
Curium strikes up to $8B deal for radiopharma rival Lantheus
fiercebiotech
18d
STAT+: Is there a pharma mega-merger in the making?
stat
18d
STAT+: BioNTech names Guido Oelkers its new CEO
stat
18d
Amgen hit with cybersecurity breach, patient data affected
biospace
18d
After 5-month wait, BioNTech announces Sobi CEO will take on top job at mRNA company
fiercebiotech
18d
Biotech leaders call for streamlining of INDs as FDA’s Trialblazer rolls out
biospace
18d
5 companies advancing ATTR assets in the wake of Wainua’s fail
biospace
21d
Capricor CEO won’t rule out legal action against FDA after negative adcomm
biospace
21d
Lilly and Resilience invest $750M in diabetes and obesity drug device supply
biospace
21d
Novo's IL-6 inhibitor fails in cardiovascular Phase 3, plunging shares more than 9%
biospace
21d
Moderna maintains 10% growth target despite Phase 3 norovirus miss
biospace
21d
STAT+: Pharmalittle: We’re reading about a Novo setback, support for Replimune’s melanoma drug, and more
stat
21d
UniQure welcomes possible adcomm for Huntington’s asset as regulatory ‘jitters’ spread through biopharma
biospace
21d
‘It’s making a difference’: Madrigal CEO talks strategy behind MASH shopping spree
fiercebiotech
21d
Opinion: Limb girdle muscular dystrophy patients face a maddening reality
stat
21d
Apnimed raises $192M IPO for potential 2027 sleep apnea drug launch
endpoints
21d
Apnimed’s IPO dream comes true with upsized $192M IPO to fund sleep apnea pill launch
fiercebiotech
22d
Replimune overcomes ‘messy data’ to secure positive adcomm vote for melanoma therapy
biospace
22d
Replimune melanoma drug wins support of FDA panel
biopharma dive
22d
Replimune scores win as FDA advisors back melanoma treatment
endpoints
22d
Replimune’s twice-rejected melanoma drug prevails in FDA adcomm
fiercebiotech
22d
Key Senate panel backs Trump’s picks for CDC, pandemic preparedness
stat
22d
Daiichi’s pipeline falls behind rivals as cash flow nears peak: analysts
biospace
22d
STAT+: Pharmalittle: We’re reading about an FDA panel nixing a Duchenne drug, FTC suing Hims & Hers, and more
stat
22d
Ebola outbreak nears milestone, while a vaccine remains months away
stat
22d
STAT+: FDA expert committee votes in favor of Replimune’s melanoma treatment
stat
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