Drug Approval | October 16, 2024
Shilpa Medicare’s CDMO customer gets fast-track designation for its investigational drug candidate
GBM affects nearly 13,000 patients annually in the US and approximately 300,000 globally
GBM affects nearly 13,000 patients annually in the US and approximately 300,000 globally
Lyka has received the CDSCO approval for manufacturing and marketing of Pregabalin Gel 8% w/w
India has been declared ‘functional’ against all the core regulatory functions of the WHO Global Benchmarking Tool Version VI
The partnership marks a pivotal step towards developing new therapies for combating Sickle Cell Disease
The GMP certificate will allow the manufacturing site in Hervás, Cáceres to manufacture active ingredients for the pharmaceutical industry that is based on medicinal plants
HYMPAVZI’s approval is based on Phase 3 study results demonstrating substantial bleed reduction compared to routine prophylaxis
Under the licensing agreement, Alkem will carry out the clinical development of “SON-080” in India with support from Sonnet and enable global and India regulatory filings
Approval is based on Phase III INAVO120 results, showing the Itovebi (inavolisib)-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting
India’s first trial for a novel autologous BCMA directed CAR-T cell therapy in patients with relapsed / refractory multiple myeloma
WEF recognises company’s Bharuch manufacturing facility as a global manufacturing lighthouse
Subscribe To Our Newsletter & Stay Updated
