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Approval · news · pharmadog
← back to Approval
News · Approval
636
stories
8h
FDA rejects Osteal combo therapy to treat joint-implant infections
endpoints
10h
Regeneron to challenge Ipsen as FDA clears bone disease drug
biopharma dive
11h
Ultragenyx, after setbacks, nabs first gene therapy approval
biopharma dive
12h
Try first, evaluate later: How the FDA is approaching digital health devices
endpoints
12h
STAT+: FDA approves Ultragenyx gene therapy
stat
13h
STAT+: Pharmalittle: We’re reading about a Regeneron rare disease drug, an Ultragenyx gene therapy, and more
stat
14h
Regeneron wins FDA approval to challenge Ipsen for rare bone disease market
biospace
14h
Ultragenyx bags first gene therapy approval as previously rejected Sanfilippo asset awaits decision
biospace
14h
Merck’s Moderna-partnered vaccine success clears view of post-Keytruda future
biospace
15h
FDA approves Ultragenyx's gene therapy Genglycos for glycogen storage disorder
endpoints
16h
STAT+: Capricor Therapeutics’ Duchenne treatment is heading for an FDA rejection
stat
16h
STAT+: One of the most consequential years for cancer treatment, ever
stat
18h
Opinion: Capricor’s Duchenne muscular dystrophy drug and the countless tiny decisions that can make or break a study
stat
18h
Meet Aletta: The first FDA approved robotic blood draw device
fiercebiotech
1d
FDA Approves First Therapy for Patients aged 8 years and older with Glycogen Storage Disease Type Ia
fda press
1d
Trump's FDA pick Overton good for psychedelics, new pain meds but bad for vaccines: Analysts
biospace
1d
FDA approves Regeneron’s garetosmab for disease that turns tissue to bone
endpoints
1d
STAT+: Experts scrutinize Huidagene’s disclosures after patient death
stat
1d
STAT+: Regeneron drug for disease that causes dangerous bone growth earns FDA approval
stat
1d
FDA Authorizes First-Of-Its-Kind Robotic Blood Draw Device
fda press
1d
Kolon TissueGene cuts 37 US staffers after Phase 3 fail
biospace
1d
Moderna stock nearly doubles as Merck-partnered mRNA cancer vaccine meets Phase 3 goal
biospace
1d
STAT+: Pharmalittle: We’re reading about an FDA commish nominee, mRNA cancer vaccine results, and more
stat
1d
Amylyx’s redemption story, Summit’s survival woes, Definium’s anxiety win, more
biospace
1d
Developing a Global Clinical Trial Strategy for Emerging Biotechs
fiercebiotech
1d
Takeda leads wave of orexin drugs with potential to upend narcolepsy market
biospace
1d
Novo takes first round of oral obesity duel. Can it stay ahead of Lilly?
biospace
2d
Merck, Moderna’s personalized cancer vaccine slows recurrence in phase 3, setting up approval push
fiercebiotech
2d
Kolon TissueGene shrinks workforce after pivotal osteoarthritis trial miss
fiercebiotech
2d
AstraZeneca scores in lung cancer; Sandoz inks a China deal
biopharma dive
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