ImCheck’s ICT01 receives FDA ODD for treatment of acute myeloid leukemia

Clinical data showing unprecedented remission rates in newly diagnosed AML patients support advancing ICT01 into pivotal trials

Bayer’s Nubeqa receives EU approval for patients with advanced prostate cancer

European Commission granted approval of darolutamide in combination with androgen deprivation therapy (ADT) for patients with metastatic hormone-sensitive prostate cancer (mHSPC)

Biogen to invest $2 billion to expand manufacturing capability in North Carolina

Investment builds on Biogen’s 30-year history of manufacturing in the region, with approximately $10 billion invested to date

Bristol Myers Squibb announces topline Results from Phase 3 Independence trial for Reblozyl

Reblozyl is a standard of care for the first-line treatment of anemia without previous erythropoiesis stimulating agent use

Concord Biotech announces successful completion EU GMP inspection at its API facility

This achievement underscores our unwavering commitment to upholding the highest standards of quality, safety, and regulatory compliance

Lupin achieves GMP certification from TGA Australia for Dabhasa API facility

Brenntag Specialties Pharma offering phosphate-based excipients by Budenheim

Phosphate-based excipients provide higher bulk densities and enable the reduction of the tablet sizes

Lupin receives Form 483 with 4 observations from USFDA for Pithampur unit-2

The company is addressing these observations comprehensively

Biocon Biologics expands diabetes portfolio with FDA approval of Kirsty

Shilpa Medicare receives EIR from USFDA for Unit VI, Bengaluru

This facility is capable of manufacturing, packaging, testing, storage and distribution of two types of complex dosage forms