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

Biofrontera scores FDA filing acceptance for Ameluz PDT in skin cancer breakthrough

If approved, Ameluz would become the first and only photodynamic therapy (PDT) photosensitizer for sBCC in the US

STADA & Bio-Thera bag European nod for Gotenfia

NATCO receives CDSCO approval for Semaglutide in India

Semaglutide is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus

Zydus receives final approval from USFDA for Ammonium Lactate Cream, 12%

FDA nod to Acrotech's new eczema treatment

ADQUEY’s approval opens the door to a new alternative for millions of Americans struggling with atopic dermatitis

FDA refuses to file Moderna’s seasonal flu vaccine application, citing comparator issue

The FDA’s Center for Biologics Evaluation and Research (CBER) cited Moderna’s choice of a licensed standard-dose flu vaccine as the comparator in its Phase 3 trial, saying it “does not reflect the best-available standard of care.”

Alembic Pharmaceuticals gets USFDA nod for generic Parkinson's disease treatment tablets

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Stalevo Tablets

Zydus receives USFDA ODD for Desidustat for the treatment of sickle cell disease

This Orphan Drug Designation from the USFDA underlines the urgent medical need to develop a therapy for sickle cell disease

Pfizer’s HYMPAVZI bags FDA priority review, targeting younger & hard-to-treat hemophilia patients

HYMPAVZI is already approved in the US for patients 12 and older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors

Zydus receives FDA’s tentative approval for Dapagliflozin Tablets