FDA Grants Orphan Drug Status to HanchorBio's HCB101 for Gastric Cancer
The Orphan Drug Status designation to HanchorBio supports development of next-generation CD47–SIRPα immunotherapy for advanced gastric adenocarcinoma across HER2-positive and HER2-negative subtypes.
Drug Discovery & Development | 16/02/2026 | By News Bureau | 154
US Food and Drug Administration has accepted the supplemental New Drug Application submitted by Biofrontera for its photodynamic therapy product Ameluz, used with the RhodoLED red-light lamp system, for the treatment of superficial basal cell carcinoma.
Drug Discovery & Development | 15/02/2026 | By Darshana | 147
Syngene Partners with Johns Hopkins University for Early Drug Discovery
The collaboration between Syngene International and John Hopkins University is anchored in Syngene’s SynVent platform and Connector model to accelerate promising academic research.
Drug Discovery & Development | 13/02/2026 | By News Bureau | 189
Galderma Launches First OBT-Based Restylane Injectables in Japan
Galderma has launched Restylane Defyne and Restylane Refyne in Japan, marking the first authorization of hyaluronic acid injectables powered by its proprietary Optimal Balance Technology (OBT) in the country.
Drug Discovery & Development | 12/02/2026 | By Darshana | 188
Barzolvolimab Shows Sustained, Off-Treatment Benefits in Chronic Spontaneous Urticaria at AAAAI 2026
Phase II data presented at AAAAI 2026 show barzolvolimab achieved rapid, durable complete responses in chronic spontaneous urticaria, with sustained disease control observed months after treatment discontinuation.
Drug Discovery & Development | 12/02/2026 | By News Bureau | 351
Novo Nordisk Plans Wegovy Vial Launch to Expand Obesity Care Options
Danish drugmaker Novo Nordisk is planning to introduce vial presentations of its blockbuster obesity treatment Wegovy (semaglutide), expanding the range of delivery formats available for the therapy as competition intensifies in the weight-management market.
Drug Discovery & Development | 12/02/2026 | By Darshana | 219
Takeda's Oveporexton NDA Accepted by US FDA with Priority Review for Narcolepsy Type 1
FDA grants Priority Review to Takeda’s investigational orexin receptor agonist oveporexton (TAK-861) for narcolepsy type 1, with a PDUFA decision expected in Q3 this year.
Drug Discovery & Development | 11/02/2026 | By News Bureau | 190
FDA Grants Breakthrough Therapy Designation to Sanofi's Wayrilz for Rare Blood Disorder wAIHA
The US FDA has granted breakthrough therapy designation to Wayrilz (rilzabrutinib) for warm autoimmune haemolytic anaemia, while Japan’s health ministry awarded orphan status, accelerating development for the rare disorder.
Drug Discovery & Development | 11/02/2026 | By News Bureau | 181
MerryLife Biomedical Reports Positive Phase I Data for Oral Alzheimer's Therapy TML-6
MerryLife Biomedical’s investigational oral therapy TML-6 demonstrated favourable safety and tolerability in Phase I, paving the way for a 210-patient global Phase II trial in early Alzheimer’s disease.
Drug Discovery & Development | 10/02/2026 | By News Bureau | 140
Innovent Biologics and Eli Lilly Forge Strategic Collaboration in Oncology and Immunology
Innovent Biologics will receive USD 350 million upfront and up to USD 8.5 billion in milestones under a new global development pact, with Lilly securing ex-Greater China rights to novel oncology and immunology programmes.
Drug Discovery & Development | 10/02/2026 | By News Bureau | 154
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