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The FDA Friday gave a green light to the first U.S. biosimilar, finding Sandoz’s Zarxio clinically comparable to Amgen’s blockbuster chemotherapy product Neupogen. Read More
Bristol-Myers Squibb's cancer drug Opdivo has gained a new indication as a second line treatment for metastatic squamous non-small cell lung cancer that has progressed after platinum-based chemotherapy. Read More
European regulators have granted Celgene’s nanotechnology-based therapy Abraxane its third cancer indication as a first-line treatment alongside carboplatin for non-small cell lung cancer patients who don’t qualify for surgery or radiation therapy. Read More
The FDA has postponed an advisory committee meeting that had been scheduled to consider Celltrion’s application for a biosimilar to Janssen’s Remicade — just the second advisory committee meeting to consider a biosimilar application in the U.S. Read More
The FDA is seeking additional comment from industry on its highly controversial proposed rule giving generics makers the same authority brandmakers have to update their product labels without agency approval when new safety information about a drug emerges. Read More
The FDA has accepted Apotex’s BLA for a biosimilar of Amgen’s blockbuster chemotherapy product Neupogen, the Canadian generics maker said Feb. 17, making it the fifth publicly disclosed biosimilar application in the U.S. Read More
The UK’s healthcare cost watchdog today gave a positive nod to Gilead Sciences’ hepatitis C combination therapy Harvoni for certain genotype 1 and 4 patients. Read More
The FDA on Friday approved Actavis and Medicines 360’s Liletta, a drug-eluting intrauterine device that prevents pregnancy for up to three years. Read More
Australian drugmakers want the government to create fast-track approval pathways for new cancer drugs, as well as parallel review processes that simultaneously assess safety and efficacy and reimbursement eligibility for new drugs. Read More
The FDA Wednesday approved Actavis’ Avycaz, a new antibiotic for adults with complicated intra-abdominal infections and complicated urinary tract infections, including kidney infections. Read More
The FDA has postponed an advisory committee meeting that had been scheduled to consider Celltrion’s application for a biosimilar to Janssen’s Remicade – just the second advisory committee meeting to consider a biosimilar application in the U.S. Read More