Wanbury secures 9 USFDA ‘No DMF Deficiency’ letters for Metformin as it expands in Saudi & Mexico

Wanbury has commercialised a new Metformin direct-compression (DC) business in Saudi Arabia

Alembic Pharma secures USFDA approval for ear infection suspension

The approved ANDA is therapeutically equivalent to the reference listed drug, Ciprodex Otic Suspension (0.3%/0.1%) by Sandoz

USFDA inspection at Zydus Moraiya plant concludes with five observations

Zudus will submit a formal written corrective action plan within the stipulated timelines

China nod to Foresee Pharma’s CAMCEVI 42 mg for advanced prostate cancer

The approval paves the way for GenSci to launch CAMCEVI 42 mg in China

FDA accepts Zydus and Formycon’s first-of-its-kind Keytruda Biosimilar for review

Zydus holds exclusive commercialization rights for the United States and Canada and brings extensive commercial experience in the North American market for this product.

FDA nod to Hovilpri for drug-resistant herpes infections in immunocompromised adults

The FDA approval is backed by results from the Phase 3 PRIOH-1 trial

Shilpa Medicare wins EU GMP nod for Jadcherla unit after Austrian audit

European GMP certification validates compliance standards at the Jadcherla finished dosage facility

US FDA conducts inspection at Rubicon Research’s Satara facility

Dr. Reddy's FTO-11 plant in Andhra Pradesh gets two USFDA Form 483 observations

The company stated it will address the observations comprehensively within the stipulated timeline

Dignify Therapeutics bags FDA nod to begin human trials of on-demand bowel therapy

Dignify expects to begin dosing healthy volunteers in November 2026

Lupin receives USFDA approval for Phytonadione Injectable Emulsion

The FDA has approved Lupin's Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-dose Prefilled Syringe

FDA nod to Novartis’ Rhapsido as first treatment for symptomatic dermographism

Rhapsido is an oral, highly selective Bruton’s tyrosine kinase inhibitor

FDA approves Teva's first once-monthly schizophrenia injection 'Weltruza'

The approval is based on results from the pivotal Phase 3 SOLARIS trial, which demonstrated overall symptom improvement

FDA accepts Bayer supplemental application for Finerenone in non-diabetes CKD

The supplemental New Drug Application (sNDA) was based on the positive Phase III FIND-CKD study results

Granules India eyes potential 180-day US exclusivity for Ruxolitinib ER

Granules India believes it may qualify for first-to-file status for Ruxolitinib Extended-Release Tablets, subject to FDA review and determination

AbbVie’s Temab-A wins two FDA breakthrough designations for colorectal & lung cancers

The FDA granted one designation for Temab-A in combination with bevacizumab for adults with refractory, metastatic colorectal cancer

HUTCHMED & AstraZeneca file US application for ORPATHYS–TAGRISSO lung cancer combo

The filing is backed by results from the global Phase III SAFFRON trial

TriLink bags second CleanCap patent in China strengthening RNA technology IP

The new patent is distinct from and additive to Chinese Patent No. ZL202511246578.X, which covers methods for synthesizing capped RNA molecules

Aurobindo Pharma secures USFDA final approval for multi-strength Perampanel tablets

The product will be manufactured at Unit-IV of APL Healthcare

USFDA expands Camzyos approval to children with obstructive hypertrophic cardiomyopathy

The approval is based on results from the Phase 3 SCOUT-HCM trial, which enrolled 44 adolescents aged 12 to under 18 with symptomatic oHCM