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Approval · news · pharmadog
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News · Approval
636
stories
2d
Leo Pharma buys rare skin disease drug in $435M deal
biopharma dive
2d
STAT+: Pharmalittle: We’re reading about a setback for Eyepoint, a win for Amylyx, and more
stat
2d
LEO adds to dermatology portfolio with $435M deal for late-stage rare disease drug
biospace
2d
Kindergarten vaccine exemptions are climbing
stat
2d
Regeneron ends eye disease study due to antibody's safety profile
biospace
2d
Amylyx’s bet on a GLP-1 blocker pays off
biopharma dive
2d
Amylyx eyes FDA filing for GLP-1 blocker after late-stage win in post-bariatric hypoglycemia
biospace
2d
STAT+: Amylyx endocrine drug succeeds in pivotal study
stat
2d
Johnson & Johnson MedTech nabs Monarch Quest 3 update for lung cancer detection
fiercebiotech
3d
Study highlights difficulty of measuring non-clinical factors that could influence FDA drug approval decisions
raps
3d
FDA issues draft guidance clarifying differences between ANDAs and 505(b)(2) applications
raps
3d
STAT+: Eyepoint study results for vision treatment disappoint, but company still sees promise
stat
3d
Amylyx readies approval push after GLP-1 inhibitor halves blood sugar crashes in ph. 3 win
fiercebiotech
3d
Argenx jumps on Phase 3 data for blockbuster Vyvgart
biopharma dive
3d
EyePoint plummets on pivotal data for main drug
biopharma dive
3d
Summit, Akeso's ivonescimab shows smaller benefit with longer follow-up in China
endpoints
3d
Summit, Akeso’s China approval celebration cut short as survival benefit degrades
biospace
3d
Regeneron ends eye disease trial for anti-CD3 antibody following safety review
fiercebiotech
3d
STAT+: Akeso and Summit’s lung cancer drug shows worsening tumor-progression benefit
stat
3d
Celcuity awaits FDA review for second factory to launch cancer drug
endpoints
3d
FDA nod is just the first hurdle for Moderna’s potential blockbuster flu vax
biopharma dive
3d
Vera’s newly approved IgA nephropathy drug supports kidney function, like Otsuka’s Voyxact
biospace
3d
Leo ‘really strengthening’ pipeline with $435M deal for Tanabe rare skin disease drug awaiting FDA nod
fiercebiotech
3d
FDA clears Lantheus’ Alzheimer’s PET imaging agent Tauklarify
fiercebiotech
3d
How AI-enabled Software as Medical Devices are Reshaping Regulatory Routes and Medicine
biospace
4d
Asia-Pacific Roundup: Saudi FDA streamlines rare disease drug development
raps
4d
Recon: FDA approves Zenbexus for multiple myeloma; NSAI seeks buyer for its MDR notified body business
raps
6d
Biogen's monoclonal antibody felzartamab wins first global approval in China
endpoints
6d
Bristol Myers wins ‘milestone’ FDA approval of myeloma drug acquired from Celgene
biopharma dive
6d
STAT+: PBMs agree to display TrumpRx drug prices
stat
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