Latest Headlines

Latest Headlines

BMS racks up another Opdivo approval after FDA makes quick decision

Bristol-Myers Squibb has won yet another approval for its pioneering immuno-oncology drug Opdivo. The regulatory nod in advanced renal cell carcinoma, a form of kidney cancer, comes just one week after the FDA accepted the filing for priority review.

FDA approves BMS' Opdivo for kidney cancer a week after granting priority review

In another striking FDA turnaround for Bristol-Myers Squibb's Opdivo, the agency has approved it for treating advanced renal cell carcinoma just a week after granting priority review.

Takeda's Velcade successor gets quick FDA approval

The FDA has approved Takeda Pharmaceutical's Ninlaro, a treatment for multiple myeloma that the Japanese company hopes can get established before its blockbuster Velcade loses patent protection.

Novartis snags new approvals for Cosentyx in Europe

Novartis has been jockeying for additional uses for its next-gen psoriasis med, Cosentyx, hoping that a trifecta of indications will help generate blockbuster sales and distinguish the drug from its competition in a hot market. Now the med is moving one step closer toward achieving its blockbuster aspirations with an EU nod to treat patients with psoriatic arthritis and ankylosing spondylitis.

India-EU trade talks back on next year, GVK issue sidelined

India's efforts to smooth over trade disputes with the European Union will lead to a resumption of bilateral talks early next year, but GVK Biosciences will have to be satisfied with watching from the sidelines.

Japan's Takeda gets early U.S. FDA nod for ixazomib

Japan's Takeda Pharmaceutical won early U.S. Food and Drug Administration approval for ixazomib (Ninlaro) to treat multiple myeloma ahead of its scheduled PDUFA review in March next year, the company said in a press release.

Samsung Bioepis biosimilar gets 'positive opinion' from European agency

South Korea's Samsung Bioepis said its biosimilar drug Benepali, used in the treatment of rheumatoid arthritis and other autoimmune diseases, has received a "positive opinion" from the European Medicines Agency's Committee for Medicinal Products for Human Use.

China healthcare reforms in gear, but not fast enough for some

China is moving on several fronts to make it easier and safer for potential patients to use the nation's expanding healthcare system, with a new emphasis on drug regulations, devices and elderly care. Even so, American drugmakers say the government should do even more in the drugs area.

FDA gives scientists freedom to tweet in long-awaited social media policy

The regulator, which has faced criticism in the past over its failure to establish a policy, set out its position in a 12-page document.

Takeda's 'breakthrough' Velcade heir wins early FDA approval in myeloma

Takeda Pharmaceutical's top cancer prospect won a speedy FDA approval, wading into a crowded market for multiple myeloma treatments with hopes of duplicating the success of Velcade.