NATCO Pharma receives 7 observations from USFDA for API unit at Manali

Ind-Swift Laboratories receives certifications from Bureau Veritas

These certifications reflect the company's continuous commitment to maintaining international standards of environmental sustainability as well as occupational health and safety

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

Bayer’s experimental stroke drug could reshape secondary stroke prevention

Millions of stroke survivors across the world may soon have a new defense

Texas hits Sanofi, Bristol-Myers Squibb with lawsuit over blood thinner drug efficacy

Paxton alleges the companies marketed Plavix as a reliable defense against heart attacks, strokes, and blood clots while failing to disclose evidence that the drug could be ineffective or virtually useless for many people

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

Contineum MS drug stumbles in mid-stage trial

Topline results from the Phase 2 VISTA trial show that PIPE-307 did not meet its primary or secondary efficacy endpoints

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

Croda partners with Amino to expand biopharma capabilities

The partnership combines Croda’s deep expertise in smart science and global market reach with Amino’s advanced capabilities in precision manufacturing of amino acids