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The regulatory agency issued a complete response letter (CRL) to the company’s New Drug Application (NDA) for lenacapavir mentioning Chemistry Manufacturing and Controls (CMC) issues related to its

Jointly developed and commercialised by Pharmacyclics, Imbruvica (ibrutinib) is a once-daily oral medication that blocks the Bruton’s tyrosine kinase (BTK) protein. The sNDA seeks approval for the drug

Keytruda is Merck’s an anti-programmed death receptor-1 (PD-1) therapy that increases the ability of the immune system in body for detecting and fighting tumour cells. It is a

The investigational, phosphodiesterase 4B (PDE4B) inhibitor, BI 1015550 has the potential to address pulmonary fibrosis as well as inflammation linked to progressive fibrosing interstitial lung diseases (ILDs). Pulmonary

INNA-051 is a broad spectrum antiviral immunomodulatory nasal spray, which is under clinical development to treat pre- and post-exposure prophylaxis of respiratory viral infections in people at risk

Cariprazine is intended for the adjunctive treatment of MDD patients who are receiving ongoing antidepressant therapy. The company’s sNDA submission is based on data obtained from clinical trials

Utidelone Injection, developed by Beijing Biostar Pharmaceuticals, is a new natural microbial small-molecule anticancer drug that is a genetically engineered epothilone derivative. It is a new non- taxane

DZD4205 (Golidocitinib) is a selective JAK1 inhibitor in relapsed/refractory peripheral T-Cell lymphoma. The orally available, JAK1-specific inhibitor has showed that 21 (42.9%) out of the 49 patients have

Led by Perceptive Advisors, the financing round has seen participation from existing investors RA Capital Management, Wellington Management, and Moore Strategic Ventures. The new investors include Declaration Partners,