Sanofi flags delay in FDA review of Tolebrutinib for progressive multiple sclerosis

Sanofi secures two breakthrough nods in China for rare blood disorders

Qfitlia is the first antithrombin (AT)-lowering therapy approved for routine prophylaxis in hemophilia

Alphyn Biologics bags $25 million financing to advance breakthrough skin disease therapies

Alphyn is developing Zabalafin Hydrogel as the first therapy to simultaneously tackle the interconnected drivers of AD

Anova launches AI-powered patient matching platform to speed clinical trial enrollment

Clinical trial enrollment has long been a bottleneck in drug development

Indoco receives EIR from the USFDA for its API manufacturing facility at Patalganga

Indoco received the Establishment Inspection Report from the USFDA for its API manufacturing facility

Eiko LifeSciences to acquire 51% stake in SSM Formulations

The plant can reach an annual capacity of 300 crore tablets and 90 crore capsules

Akums launches advanced Gabapentin ER for PHN management with RetenEx technology

Biocon Biologics strikes deal to sell its version of the eye drug Aflibercept worldwide

All pending litigation between Biocon Biologics, Regeneron, and Bayer will be dismissed

EMA backs higher-dose Wegovy, clearing path for greater weight loss option in Europe

EMA backs Eylea 8 mg for retinal vein occlusion

The positive CHMP opinion is supported by results from the Phase III QUASAR trial

Merck wins key EU backing to expand use of PAH Drug WINREVAIR

WINREVAIR is currently the first and only activin signalling inhibitor approved for PAH across all 27 EU member states

Glenmark Pharmaceuticals USA to launch Leucovorin Calcium for Injection USP, 350 mg/vial single-dose vial

Glenmark's Leucovorin Calcium for Injection USP, 350 mg/vial Single-Dose Vial is bioequivalent and therapeutically equivalent to the reference listed drug

Alembic receives USFDA final approval for Loteprednol Etabonate and Tobramycin Ophthalmic suspension

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5%/0.3%, of Bausch & Lomb

FDA fast-tracks first drug nod under new national priority voucher program

The approval of Augmentin XR, granted to USAntibiotics, directly supports the CNPV program’s goals

Roche bags CE Mark for automated mass spectrometry antibiotics monitoring

The cobas Mass Spec solution Ionify reagent portfolio now covers therapeutic drug monitoring for immunosuppressants and antibiotics

FDA nods spotlight precision oncology platforms as market surges towards $212 billion by 2034

The U.S. oncology market is projected to soar from $81 billion in 2025 to $212 billion by 2034

Formation Bio snaps up global rights to next-gen CNS TYK2 inhibitor from Lynk Pharma

LNK01006 is designed to deliver potent, selective inhibition of TYK2-mediated cytokine signaling with central nervous system exposure

Lupin Manufacturing Solutions partners with PolyPeptide to scale global peptide supply chain

This partnership strengthens LMS as a leading CDMO supplier of peptide materials for both innovator and generic markets

Shilpa Medicare receives initial authorization for Rotigotine transdermal patch from Europe

This is the first approval of a prescription transdermal dosage Form in the European markets from this facility

Senores Pharmaceuticals launches of Deferiprone Tablets USP, 500 mg & 1000 mg

The product will be marketed by Dr. Reddy's Laboratories Inc.