Lupin receives EIR from FDA for its Goa facility

The EIR was issued following an inspection of the facility from November 10 to November 21, 2025

Zydus hits Keytruda biosimilar milestone with successful FYB206 trial, targets USFDA filing

Zydus has in-licensed FYB206, a proposed biosimilar to immuno-oncology therapy Keytruda (pembrolizumab), exclusively from Formycon AG for the U.S. and Canadian markets

FDA nod to Boehringer Ingelheim’s first-line therapy for HER2-mutant lung cancer

Zongertinib is setting a new standard as the first targeted therapy for treatment naïve patients with HER2-mutant advanced non-small cell lung cancer with demonstrated efficacy

Pfizer bags rull FDA nod for BRAFTOVI combination in aggressive colorectal cancer

BRAFTOVI in combination with cetuximab and mFOLFOX6 had previously received accelerated approval in December 2024 based on objective response rate (ORR) results

Merck Animal Health gets FDA nod for groundbreaking dog allergy drug NUMELVI

Alembic Pharma secures USFDA approval for generic Lamotrigine orally disintegrating tablets

The approved product is a generic version of the reference listed drug (RLD) Lamictal ODT by GlaxoSmithKline and is indicated for the treatment of epilepsy and bipolar disorder

Eugia Pharma receives USFDA Approval for Everolimus tablets

Alembic announces USFDA final approval for Efinaconazole Topical Solution, 10%

Efinaconazole Topical Solution is indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.

Caplin Steriles gets USFDA approval for Sodium Phosphate injection

Sodium Phosphates Injection is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake

Indoco Remedies receives final ANDA approval from USFDA for Brivaracetam Oral Solution, 10 mg/mL

Brivaracetam Oral Solution (10 mg/mL) is a prescription antiepileptic drug (anticonvulsant) used for treatment of partial-onset seizures in patients 1 month of age and older