TMCnet

Biologics License Application for Subcutaneous Formulation of "LEQEMBI®" (lecanemab) for the Treatment of Early Alzheimer's Disease Accepted in China

Eisai serves as the lead of LEQEMBI development and regulatory submissions globally with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making ...
CURE

FDA Application Submitted for Rusfertide Treatment in Polycythemia Vera

Takeda and Protagonist Therapeutics have submitted a new drug application to the FDA for rusfertide for adults with ...

MannKind Provides Business Updates and 2026 Growth Drivers

MannKind closed 2025 on a high note, marked by milestones that reinforce our growth trajectory—including the acquisition of scPharmaceuticals and a record-setting fourth quarter surpassing $100 ...
Mirage News

Space Station Research Fuels New FDA-Approved Cancer Drug

European Space Agency (ESA) astronaut Thomas Pesquet removes the Protein Crystallization Facility hardware from an incubator ...

Arrowhead Pharmaceuticals Announces Health Canada Approval of REDEMPLO™ (plozasiran) to Reduce Triglycerides in Adults with Familial Chylomicronemia Syndrome (FCS)

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that Health Canada has issued a Notice of Compliance (NOC) authorizing REDEMPLO™ (plozasiran), a small interfering RNA (siRNA) medicine, ...
Le Lézard

Arrowhead Pharmaceuticals Announces Health Canada Approval of REDEMPLOtm (plozasiran) to Reduce Triglycerides in Adults with Familial Chylomicronemia Syndrome (FCS)

Arrowhead Pharmaceuticals, Inc. today announced that Health Canada has issued a Notice of Compliance (NOC) authorizing REDEMPLOtm (plozasiran), a small interfering RNA (siRNA) medicine, as an adjunct ...
The Manila Times

Johnson & Johnson submits application to the European Medicines Agency for TECVAYLI® (teclistamab) in combination with DARZALEX® (daratumumab) subcutaneous formulation for ...

Novel immunotherapy combination regimen brings together two complementary therapies to improve outcomes for people living with multiple myeloma as early as second line1 ...
Pharmabiz

Takeda & Protagonist submit NDA to US FDA seeking approval for rusfertide to treat polycythemia vera

Takeda & Protagonist submit NDA to US FDA seeking approval for rusfertide to treat polycythemia vera: Osaka, Japan Wednesday, January 7, 2026, 17:00 Hrs [IST] Takeda, focused on c ...
Le Lézard

ReAlta Life Sciences Announces Appointment of Jonathan Rigby to Board of Directors

ReAlta Life Sciences Inc. ("ReAlta" or the "Company"), a clinical-stage biopharmaceutical company focused on safely targeting neutrophils and central components of the complement system to ...
Agence France-Presse

Takeda and Protagonist Announce Submission of New Drug Application (NDA) for Rusfertide for Treatment of Polycythemia Vera (PV)

Takeda (TSE:4502/NYSE:TAK) and Protagonist Therapeutics (Nasdaq: PTGX) (“Protagonist”) announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking ...
JCN Newswire

Biologics License Application for Subcutaneous Formulation of "LEQEMBI(R)" (lecanemab) for the Treatment of Early Alzheimer's Disease Accepted in China

Eisai serves as the lead of LEQEMBI development and regulatory submissions globally with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making ...
Rheumatology Advisor

Phase 3 Data Support Subcutaneous Anifrolumab for Disease Control in SLE

Phase 3 trial data show subcutaneous anifrolumab improves BICLA response rates and reduces oral corticosteroid use in systemic lupus erythematosus.