FDA grants ODD to Keros KER-065 for treatment of Duchenne muscular dystrophy

KER-065 is a novel ligand trap comprised of a modified ligand-binding domain derived from activin receptor type IIA and activin receptor type IIB

Eris Lifesciences receives ANVISA approval at its Ahmedabad campus

FDA approved Dawnzera in US as first and only RNA-targeted prophylactic treatment for hereditary angioedema

Dawnzera demonstrated significant and sustained HAE attack rate reduction and long-term disease control

Moderna receives Health Canada approval for updated COVID-19 vaccine targeting SARS-CoV-2 Variant LP.8.1

All 2025 pre-filled syringe doses to be made in Canada, marking a domestic production milestone

FDA approves first immunotherapy for recurrent respiratory papillomatosis

FDA grants breakthrough therapy designation to Ifinatamab Deruxtecan for lung cancer patients

Fourteenth breakthrough therapy designation granted by FDA across the oncology portfolio of Daiichi Sankyo

Zydus’ SEZ II, Ahmedabad plant clears USFDA inspection with nil observations

The inspection concluded with NIL observations

Indoco Remedies receives final USFDA approval for rivaroxaban tablets

Rivaroxaban is used to treat venous thromboembolism

Boehringer’s lung cancer medicine gets FDA approval

FDA grants accelerated approval to zongertinib for HER2 TKD-Mutated Non-Squamous NSCLC

Gland Pharma gets approval for Norepinephrine Bitartrate in 5% Dextrose injection bags

The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Norepinephrine Bitartratein 5% Dextrose of Baxter Healthcare Corp

Gland Pharma receives FDA approval for Cangrelor for Injection 50 mg/vial

The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), KENGREAL of Chiesi USA

Zydus receives final approval from USFDA for Diltiazem Hydrochloride Tablets USP

Diltiazem works by relaxing blood vessels, which reduces the workload on the heart and increases blood and oxygen supply to the heart muscle

Shilpa Medicare receives approval of NorUDCA tablets for treatment of NAFLD in India

NorUDCA is the first?in?class treatment for Non?alcoholic Fatty Liver Disease (NAFLD) in India

Zydus receives final approval from USFDA for Prucalopride Tablets

Prucalopride is prescribed for chronic idiopathic constipation

Zydus receives NOC from Health Canada for ZDS-Varenicline Tablets 0.5 &1 mg

This is the group’s first NoC approval in Canada

AbbVie submits for FDA approval of Venclexta and Acalabrutinib combination for untreated CLL patients

The submission is supported by positive results from the Phase 3 AMPLIFY trial

Akums’ Haridwar factory receives ANVISA GMP certification for sterile manufacturing plant

This certification validates the plant’s robust capabilities in manufacturing a wide range of sterile dosage forms

Alembic Pharmaceuticals announces USFDA final approval for Carbamazepine ER Tablets USP

Carbamazepine Extended-Release Tablets are indicated for use as an anticonvulsant drug

Concord Biotech successfully completes Russian GMP inspection at its API facility

The inspection was conducted from July 22-25, 2025

NATCO Pharma API unit in Mekaguda receives EIR from USFDA

The company received one observation in the Form-483