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

Biocon Biologics expands diabetes portfolio with FDA approval of Kirsty

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

Zydus receives final approval from USFDA for Celecoxib Capsules

Celecoxib is a nonsteroidal anti-inflammatory drug

Sun Pharma settles patent litigation with Incyte

Briefs: Emcure Pharmaceuticals and Gland Pharma

Emcure Pharmaceuticals successfully completes USFDA PAI of Oncology facility

AB Science receives FDA and EMA authorization for phase 3 Trial of prostate cancer treatment

Masitinib is targeted at patients who are no longer responding to hormone-sensitive prostate cancer treatments

Lupin launches nasal spray in US

Ipratropium Bromide Nasal Solution (Nasal Spray), 0.03% and 0.06% are bioequivalent to Atrovent Nasal Spray, 0.03% and 0.06%, of Boehringer Ingelheim Pharmaceuticals

Lupin receives USFDA approval for Loteprednol Etabonate Ophthalmic Gel

Loteprednol Etabonate Ophthalmic Gel, 0.38% is a corticosteroid indicated for the treatment of postoperative inflammation and pain following ocular surgery