AstraZeneca’s Imfinzi-based perioperative regimen approved in EU for resectable non-small cell lung cancer

Approval based on AEGEAN Phase III trial results which showed a 32% reduction in the risk of recurrence, progression or death vs. neoadjuvant chemotherapy alone

Enhertu approved in EU in post-ET breast cancer

Approval brings AstraZeneca and Daiichi Sankyo’s Enhertu earlier in the treatment of HR-positive, HER2-low breast cancer and broadens the eligible patient population to those with HER2-ultralow disease

Alembic announces USFDA final approval for Pantoprazole Sodium for Injection, 40 mg/vial

Pantoprazole Sodium for Injection, 40 mg/vial (Single-Dose Vial) have an estimated market size of US$ 48 million for twelve months ending December 2024 according to IQVIA

Morepen secures Loratadine approval for export to China

This marks a significant milestone in Morepen’s strategic entry into one of the world’s largest pharmaceutical markets

OneSource Specialty Pharma updates on cGMP inspection by USFDA

The inspection has concluded with four observations

Merck seeks FDA approval for subcutaneous pembrolizumab

Subcutaneous pembrolizumab administered every six weeks with a median injection time of two minutes, in combination with chemotherapy, shows consistent results across reported efficacy and safety endpoints compared to IV KEYTRUDA in combination with chemotherapy

European Commission approves Merck’s Capvaxive for prevention of invasive pneumococcal disease

EC decision marks the fourth approval for CAPVAXIVE for pneumococcal vaccination in adults

SMS Pharmaceuticals completes USFDA inspection at Hyderabad facility

The inspection, conducted from March 17 to March 21, 2025, concluded with one observation in Form 483

Glenmark receives ANDA approval for Olopatadine Hydrochloride ophthalmic solution USP, 0.2%

Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% (OTC), will be distributed in the US by Glenmark Therapeutics, USA.

BrePco Biopharma and Piramal Critical Care announce MHRA approval for Neoatricon in UK

PCC has secured the commercialization rights for the EU, UK, and Norway and will be responsible for distributing Neoatricon in these regions

USFDA grants Priority Review for new indication of finerenone for patients with common heart failure

Finerenone is the first drug targeting the mineralocorticoid receptor (MR) pathway to demonstrate cardiovascular benefits in a Phase III study in patients with heart failure

Zydus receives final approval from USFDA for Apalutamide Tablets, 60 mg

Apalutamide is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-sensitive prostate cancer

Briefs: Zydus, Alkem Laboratories, Alkem Medtech and Relonchem

Alkem Medtech to acquire 100% stake of Bombay Ortho

RedHill Biopharma to submit FDA-approved Talicia for UK marketing authorisation

Talicia is also approved and launched in the UAE and additional countries may accept UK MHRA approvals as a reference for their own marketing approval processes

Lupin receives tentative approval from USFDA for Amifampridine Tablets

Amifampridine Tablets, 10 mg are indicated for the treatment of Lambert-Eaton myasthenic syndrome in adults and pediatric patients 6 years of age and older.

Zydus receives final approval from USFDA for Eluxadoline Tablets, 75 mg and 100 mg

Eluxadoline is a mu-opioid receptor agonist, indicated in adults for the treatment of irritable bowel syndrome with diarrhoea

Zydus receives final approval from USFDA for Methenamine Hippurate Tablets USP, 1 gram

Methenamine Hippurate tablets are indicated for prophylactic or suppressive treatment of frequently recurring urinary tract infections

Indoco’s clinical research organisation ‘AnaCipher’ completes USFDA inspection

Zydus receives final approval from USFDA for Ketoconazole Shampoo, 2%

Ketoconazole shampoo is an antifungal medication used to treat dandruff

Briefs: Alembic Pharma and IOL Chemicals and Pharmaceuticals

USFDA inspection at Alembic Pharma's Bioequivalence facility