⚡ Top Events Today
Rocket secures accelerated FDA approval for Kresladi gene therapy for rare immune disease.
First hematopoietic stem cell-based gene therapy approved for children with severe LAD-I, granted under accelerated approval.
Novo Nordisk's once-weekly insulin for Type 2 Diabetes approved by FDA.
First US-approved once-weekly basal insulin, offering a longer-acting alternative to daily injections for maintenance treatment.
AstraZeneca's COPD candidate meets endpoints in pivotal Phase 3 trials.
Successfully met endpoints in a pair of Phase 3 trials, demonstrating broad efficacy.
Novocure reports positive data for electric field therapy in metastatic pancreatic cancer.
Reported positive clinical data from a pivotal study for its electric field-based treatment in a metastatic setting.
Corcept's first-in-class Lifyorli approved for relapsed ovarian cancer.
Approved for use alongside nab-paclitaxel for patients with relapsed disease who have undergone one-to-three prior lines of therapy.
📁 All Events (13491 stories)
Rocket received accelerated FDA approval for its hematopoietic stem cell-based gene therapy, Kresladi (marnetegragene autotemcel). This approval is for the treatment of certain children with severe leukocyte adhesion deficiency-1.
Rocket received accelerated FDA approval for its hematopoietic stem cell-based gene therapy, Kresladi (marnetegragene autotemcel). This approval is for the treatment of certain children with severe leukocyte adhesion deficiency-1.
Novocure reported positive clinical data for its electric field-based treatment in metastatic pancreatic cancer. This announcement follows an earlier FDA approval for the same treatment in local pancreatic cancer.
Novocure reported positive clinical data for its electric field-based treatment in metastatic pancreatic cancer. This announcement follows an earlier FDA approval for the same treatment in local pancreatic cancer.
The US FDA has approved the first generic version of fluticasone propionate inhalation aerosol, which is a generic equivalent to Flovent HFA. This approval is specifically for the maintenance treatment of asthma.
The US FDA has approved the first generic version of fluticasone propionate inhalation aerosol, which is a generic equivalent to Flovent HFA. This approval is specifically for the maintenance treatment of asthma.
AstraZeneca's chronic obstructive pulmonary disease (COPD) drug candidate successfully met its endpoints in a pair of Phase 3 trials. The drug demonstrated broad efficacy, providing positive results for a class that has previously seen mixed data from competitors like Roche and Sanofi.
AstraZeneca's chronic obstructive pulmonary disease (COPD) drug candidate successfully met its endpoints in a pair of Phase 3 trials. The drug demonstrated broad efficacy, providing positive results for a class that has previously seen mixed data from competitors like Roche and Sanofi.
The FDA approved Novo Nordisk's once-weekly insulin for type 2 diabetes. This is the first US-approved longer-acting alternative to daily basal treatment for this indication.
The FDA approved Novo Nordisk's once-weekly insulin for type 2 diabetes. This is the first US-approved longer-acting alternative to daily basal treatment for this indication.
The FDA granted accelerated approval to Rocket Pharmaceuticals' gene therapy for an ultra-rare immune disease on Thursday. This approval follows an earlier rejection for manufacturing problems.
The FDA granted accelerated approval to Rocket Pharmaceuticals' gene therapy for an ultra-rare immune disease on Thursday. This approval follows an earlier rejection for manufacturing problems.
The European Medicines Agency's human medicines committee (CHMP) recommended the approval of a new subcutaneous form of Sanofi's multiple myeloma drug, Sarclisa. CHMP also recommended four other new drugs for approval.
The European Medicines Agency's human medicines committee (CHMP) recommended the approval of a new subcutaneous form of Sanofi's multiple myeloma drug, Sarclisa. CHMP also recommended four other new drugs for approval.
Corcept's first-in-class drug, Lifyorli, gained FDA approval for ovarian cancer. It can be prescribed alongside nab-paclitaxel for patients who have relapsed one-to-three times.
Corcept's first-in-class drug, Lifyorli, gained FDA approval for ovarian cancer. It can be prescribed alongside nab-paclitaxel for patients who have relapsed one-to-three times.
Kodiak Sciences announced positive topline results from its GLOW2 Phase 3 study in diabetic retinopathy. Zenkuda (tarcocimab tedromer) demonstrated superiority over sham, with 62.5% of treated patients achieving a ≥2-step improvement in diabetic retinopathy severity score (DRSS) compared to 3.3% in the sham group.
Kodiak Sciences announced positive topline results from its GLOW2 Phase 3 study in diabetic retinopathy. Zenkuda (tarcocimab tedromer) demonstrated superiority over sham, with 62.5% of treated patients achieving a ≥2-step improvement in diabetic retinopathy severity score (DRSS) compared to 3.3% in
EMA Approval: Orathecin (EuroGen Pharmaceuticals Ltd)
Active substance: rubitecan | EC Decision: 31/12/2009 | Status: Application withdrawn | Flags: Orphan | Area: Pancreatic Neoplasms
EMA Approval: Surfaxin (Pharm Research Associates (UK) Limited)
Active substance: sinapultide;Dipalmitoylphosphatidylcholine;palmitoyl-oleoyl phosphatidylglycerol;palmitic acid | EC Decision: 31/12/2009 | Status: Application withdrawn | Flags: Orphan | Area: Respiratory Distress Syndrome, Newborn
EMA Approval: Voraxaze (Protherics PLC)
Active substance: glucarpidase | EC Decision: 31/12/2009 | Status: Application withdrawn | Flags: Orphan | Area:
EMA Approval: Cerepro (Ark Therapeutics)
Active substance: adenovirus-mediated Herpes simplex virus-thymidine kinase gene | EC Decision: 31/12/2009 | Status: Application withdrawn | Flags: Orphan | Area: Glioma
EMA Approval: Retisert (Bausch Lomb Ireland)
Active substance: Fluocinolone acetonide | EC Decision: 31/12/2009 | Status: Application withdrawn | Flags: Orphan | Area:
EMA Approval: Mylotarg (Wyeth Europa Ltd)
Active substance: gemtuzumab ozogamicin | EC Decision: 24/01/2008 | Status: Refused | Flags: Orphan | Area: Leukemia, Myeloid, Acute
EMA Approval: Kiacta (Neurochem Luxco II SARL)
Active substance: eprodisate disodium | EC Decision: 31/12/2009 | Status: Application withdrawn | Flags: Orphan | Area: Amyloidosis
EMA Approval: orBec (DOR BIOPHARMA UK Ltd)
Active substance: beclomethasone dipropionate | EC Decision: 31/12/2009 | Status: Application withdrawn | Flags: Orphan | Area: Graft vs Host Disease
EMA Approval: Spanidin (Euro Nippon Kayaku GmbH)
Active substance: gusperimus trihydrochloride | EC Decision: 31/12/2009 | Status: Application withdrawn | Flags: Orphan | Area: Wegener Granulomatosis
EMA Approval: Vekacia (Novagali Pharma S.A.)
Active substance: ciclosporin | EC Decision: 31/12/2009 | Status: Application withdrawn | Flags: Orphan | Area: Conjunctivitis, Allergic