News about Drug Discovery & Development

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 |  209

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 |  193

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 |  165

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 |  182

India Begins First Human Trials of Indigenous KFD Vaccine

The Indian Council of Medical Research (ICMR), in partnership with Indian Immunologicals, has advanced an indigenous vaccine candidate for Kyasanur Forest Disease (KFD), commonly known as monkey fever, into Phase I human clinical trials.

Drug Discovery & Development | 09/02/2026 | By Darshana |  258

FDA Grants Orphan Drug Designation to Zenocutuzumab for Rare Cholangiocarcinoma Subset

Partner Therapeutics secures Orphan Drug Designation for zenocutuzumab-zbco in NRG1 fusion-positive cholangiocarcinoma, strengthening development of targeted therapy for this aggressive rare cancer.

Drug Discovery & Development | 09/02/2026 | By News Bureau |  187

Evogene's Biomica Signs Global Licensing Deal with Lishan Biotech for Microbiome-Based Cancer Therapy BMC128

Lishan Biotech secures exclusive worldwide rights to develop and commercialise BMC128, a Phase I microbiome-based immunotherapy candidate showing early promise in lung and renal cancers.

Drug Discovery & Development | 07/02/2026 | By News Bureau |  166

Sun Pharma to Invest Rs 500 Crore in Expansion of Assam Manufacturing Unit

Sun Pharmaceutical Industries said it will invest Rs 500 crore to expand its manufacturing facility in Assam, aiming to strengthen its domestic production infrastructure and support future growth.

Drug Discovery & Development | 06/02/2026 | By Darshana |  247

Lupin Launches Dasatinib Tablets in USA Following FDA Approval

Lupin Limited has announced the launch of dasatinib tablets in multiple strengths in the United States following approval of its Abbreviated New Drug Application from the USA Food and Drug Administration.

Drug Discovery & Development | 03/02/2026 | By Darshana |  282

Frontage Labs Expands Early-Phase Clinical Capabilities for Global Drug Development

Frontage's US operations are anchored by a modern 160?bed, 36,000?sq?ft phase-I clinical unit in Secaucus, New Jersey, designed to conduct large?scale phase-I and bioequivalence (BE) studies as well as radiolabeled human AME research.

Drug Discovery & Development | 31/01/2026 | By News Bureau |  136