Browsing Tag
United States Food and Drug Administration
193 posts
ImmuPharma (LSE: IMM) has two biotech catalysts, but can P140 finally deliver the deal?
ImmuPharma targets a P140 licensing deal while LSE trades below its Lanstead benchmark. The next partner decision could reshape the biotech story.
Mesoblast stock gains as Ryoncil revenue hits US$115m in first launch year
Mesoblast Ryoncil revenue hits US$115m in its first launch year. Read how ASX:MSB’s biotech story is shifting from promise to sales.
Orchid Pharma (NSE: ORCHPHARMA) signs $178m Russia deal to commercialise Exblifep
Orchid Pharma signs a $178 million Russia deal for Exblifep. Read how the Pharmasyntez pact could reshape ORCHPHARMA’s global antibiotic strategy.
Vera Therapeutics wins FDA approval for Trutakna as VERA stock jumps
Vera Therapeutics wins FDA approval for Trutakna as VERA stock jumps. Read how launch execution, pricing and full approval risks shape the next phase.
Echo IQ (ASX: EIQ) slips as A$110m raise tests AI valuation
Echo IQ has A$110m and blue-chip partners, but new shares are pressuring ASX. Can FDA clearance justify its A$1.1bn valuation?
Nexsen (ASX: NXN) jumps as StrepSure validation path sharpens
Nexsen has FDA pathway momentum and Asia hospital validation. The harder test is whether ASX: NXN can turn StrepSure into revenue.
OncoSil Medical (ASX: OSL) rallies as FDA decision window opens
OncoSil is rallying into an FDA decision, but its trial was not designed to prove superiority. Can ASX turn clinical promise into sales?
Appili Therapeutics faces funding reset after NIAID terminates VXV-01 contract
Appili Therapeutics faces a funding reset after NIAID ended its VXV-01 contract. Discover what the termination means for APLI investors.
Can potravitug justify Ipsen’s €700m-plus Memo Therapeutics acquisition?
Ipsen is acquiring Memo Therapeutics to secure potravitug, a clinical-stage antibody targeting a serious kidney transplant complication. The structure limits Ipsen’s upfront exposure while placing the larger valuation behind clinical, regulatory and commercial success.
Saluda Medical wins CAP24 FDA approval as ASX:SLD shares rally 22%
Discover how Saluda Medical’s CAP24 FDA approval may expand Evoke adoption, reshape SCS competition and test ASX’s execution. Read the analysis in full.