Shilpa Medicare receives 8 observations from USFDA for Unit 4 at Jadcherla

The Unit is approved by major regulators like EMA, Europe; Health Canada, Anvisa, Brazil and TGA, Australia

FDA slaps gene therapy Elevidys with boxed warning after fatal liver failures

Elevidys came under scrutiny in June when the FDA disclosed two fatal cases in non-ambulatory boys who developed dangerously high liver enzyme levels

FDA investigates fatal case linked to rare blood disorder drug Adzynma

Adzynma, approved for both adults and children with cTTP, is a recombinant enzyme therapy designed to replace the deficient ADAMTS13 enzyme

Dr Reddy’s receives EU nod for AVT03 biosimilar denosumab

AVT03 is a biosimilar of Amgen's Prolia (denosumab 60 mg/mL) and Xgeva (denosumab 70 mg/mL), which are used to treat various bone conditions

GSK's TESARO sues AnaptysBio over alleged breach of cancer drug licence deal

FDA grants accelerated approval to sevabertinib for non-squamous non-small cell lung cancer

HER2-mutant NSCLC typically has a poor prognosis and limited treatment options

AbbVie’s EPKINLY gains FDA nod for relapsed follicular lymphoma, offering new hope for patients

The full approval is based on the results from the pivotal Phase 3 EPCORE FL-1 study

BPL Medical Technologies brings next-gen Korean ultrasound to India

The X CUBE 50 integrates ALPINION’s advanced X+ Architecture

Alkem launches globally acclaimed De Simone Probiotic in India, expands GI portfolio

The formulation is backed by over 80 clinical trials and 200 scientific publications

Mankind Pharma inks licencing pact with Actimed to bring cachexia treatments to South Asia

The licence covers Actimed’s existing patents, its proprietary know-how and any future related patents, giving Mankind full control to advance the products under its own brands