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

FDA approves Lilly's Zepbound multi-dose KwikPen for obesity treatment

In 2025, over 1 million patients accessed Lilly treatments through LillyDirect

Ultragenyx bags FDA priority review for groundbreaking GSDIa gene therapy

If approved, DTX401 would be the first treatment to address the disease at its root cause

FDA nod to AstraZeneca’s all-oral, fixed-duration therapy for CLL & SLL

The decision follows compelling data from the AMPLIFY Phase III trial, demonstrating that 77% of patients receiving the Calquence-venetoclax combination were progression-free at three years

Lupin receives European Commission approval for biosimilar Ranibizumab

FDA accepts Teva’s NDA for long-acting schizophrenia injection

If approved, TEV-'749 could help address a significant unmet need in available schizophrenia treatment options by addressing the lack of viable long-acting olanzapine formulations

FDA greenlights first all-oral, fixed-duration combo therapy for untreated CLL patients

The approval, based on results from the Phase 3 AMPLIFY trial, marks the first all-oral, fixed-duration regimen for first-line CLL therapy

FDA accepts Roche’s new drug application for Giredestrant in advanced breast cancer

The NDA filing is supported by results from the phase III evERA Breast Cancer study

Johnson & Johnson bags FDA nod for monthly RYBREVANT FASPRO dosing in advanced lung cancer

This approval builds on the recent transformation RYBREVANT FASPRO brought to lung cancer care

Zydus receives final approval from USFDA for Bosentan tablets for oral suspension, 32 mg

Bosentan 32 mg tablets for oral suspension are indicated for the treatment of Pulmonary Arterial Hypertension

FDA accepts Deciphera’s NDA for tirabrutinib in rare aggressive brain lymphoma

The drug targets relapsed or refractory primary central nervous system lymphoma, a rare and aggressive form of non-Hodgkin lymphoma

USFDA issues Form 483 with 6 observations to Enzene Biosciences’ Chakan plant following PAI

The Pre-Approval Inspection (PAI) was completed on February 13, 2026, and the company is initiating corrective actions.

FDA grants priority review to Bristol Myers Squibb's Iberdomide for multiple myeloma

Iberdomide has the potential to be the first approved CELMoD agent