Health
CSOFT’s health blog aims to provide insight into complex diseases, treatment options and regulatory developments, and other prevalent health issues people face today.
Dupixent® (dupilumab) Approved by European Commission for Children Aged 6 to 11 Years with Severe Asthma with Type 2 Inflammation
Regeneron Pharmaceuticals, Inc. and Sanofi announced that the European Commission (EC) has expanded the marketing authorization for Dupixent® (dupilumab) in the European Union. Dupixent is now also approved in children aged 6 to 11 years as an add-on maintenance...
BeiGene Announces European Medicines Agency Acceptance of Marketing Authorization Applications for Tislelizumab for the Treatment of Patients with ESCC and NSCLC
BeiGene, Ltd., a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, announced that marketing authorization applications (MAA) for tislelizumab,...
Curium Announces FDA Approval of a Generic Version of DaTscan™ (Ioflupane I 123 Injection) in the U.S.
Curium announced that its generic version of DaTscan (Ioflupane I 123 Injection) was approved on March 30, 2022, by the U.S. Food and Drug Administration (FDA). Ioflupane I 123 Injection is a single-photon emission computed tomography (SPECT) brain imaging agent used...
FDA Action Alert: BioXcel, Alnylam and Merck
After wrapping up March with a flurry of PDUFA dates, the U.S. Food and Drug Administration has a more leisurely calendar for the first three weeks of April, at least in terms of drug approvals. BioXcel Therapeutics, based in New Haven, Conn., has a target action date...
Deliberate infection trial finds COVID symptoms don’t indicate viral shedding
The world's first "human challenge" trial in which volunteers were deliberately exposed to the coronavirus has found that symptoms had no effect on how likely an infected person is to pass the disease on to others. The findings underscore the difficulty in preventing...
JW Therapeutics Announces IND Approval for the Pivotal Clinical Trial of Carteyva® in Second-line Large B-Cell Lymphoma
JW Therapeutics, an independent, innovative biotechnology company focused on developing, manufacturing and commercializing cell immunotherapy products, announced that it has received the Investigational New Drug (IND) clearance from the National Medical Products...
U.S. FDA Approves CABENUVA for Adolescents
The Janssen Pharmaceutical Companies of Johnson & Johnson announced the U.S. Food and Drug Administration (FDA) has approved CABENUVA (cabotegravir and rilpivirine) for the treatment of HIV-1 in virologically suppressed adolescents (HIV-1 RNA less than 50 copies...
FDA authorizes second booster of Pfizer/BioNTech COVID shot
U.S. regulators authorized a second booster dose of Pfizer Inc (PFE.N) and BioNTech SE's (22UAy.DE) COVID-19 vaccine for people 50 and older due to concerns about waning immunity in the age group, the drugmakers said on Tuesday. The U.S. Food and Drug Administration...
InnoCare Announces Approval of Clinical Trial of TYK2 JH2 Allosteric Inhibitor ICP-488 in China
InnoCare Pharma announced today that the company has received Investigational New Drug (IND) approval of clinical trial from the NMPA (National Medical Products Administration) for its TYK2 JH2 allosteric inhibitor ICP-488, which is the Company's third innovative drug...
Google Tests Catching Heart, Eye Issues From Smartphone Sensors
Google announced on Thursday its latest plans for using smartphones to monitor health, saying it would test whether capturing heart sounds and eyeball images could help people identify issues from home. The company, a unit of Alphabet Inc, is investigating whether the...
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