Syngene reports Q1 FY26 revenue higher at Rs. 875 Cr

Reported EBITDA up by 19% year-on-year with reported EBITDA margin at 25%

Sarepta refuses to comply with FDA request to stop shipping gene therapy Elevidys

FDA requests Sarepta Therapeutics to suspend distribution of Elevidys and places clinical trials on hold for multiple gene therapy products following 3 deaths

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

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

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

SMS Lifesciences India receives EIR with VAI status from USFDA for API facility at Kazipally

The receipt of EIR reaffirms the company's commitment to maintaining global quality standards

Lupin launches Loteprednol Etabonate ophthalmic suspension 0.5% in US

Loteprednol Etabonate Ophthalmic Suspension, 0.5% is indicated for the treatment of steroidresponsive inflammatory conditions of the palpebral and bulbar conjunctiva

Thermo Fisher Scientific to acquire Sanofi’s steriles manufacturing site in Ridgefield, New Jersey

Enables additional US manufacturing capacity to serve increased demand for pharma/biotech customers

Milestone Pharmaceuticals announces FDA acceptance of response to Cardamyst nasal spray CRL

Milestone also announced the extension of its $75 million Royalty Purchase Agreement with RTW Investments