Health News Roundup: Sanofi drug Dupixent wins FDA approval, breast-ovarian cancer

Health News Roundup: Sanofi drug Dupixent wins FDA approval, breast-ovarian cancer

Following is a summary of current health news briefs. Sanofi drug Dupixent wins FDA approval to treat asthma France’s Sanofi SA said on Friday eczema drug Dupixent was approved by the U.S. Food and Drug Administration as an additional maintenance therapy in patients with two types of asthma. Dupixent, co-developed with U.S.-based Regeneron, received approval […]

Sublingual Opioid Sufentanil Gets FDA Committee Vote, Faces Public Scrutiny

Sublingual Opioid Sufentanil Gets FDA Committee Vote, Faces Public Scrutiny

Major news outlets quick to lambast the US Food and Drug Administration (FDA) panel support for sufentanil sublingual tablet (Dsuvia) as a pain management therapy seemed to have lost crucial details when writing their headlines. This week, the FDA Anesthetic and Analgesic Drug Products Advisory Committee voted 10-3 in favor of recommendation for the marketing […]

Sanofi drug Dupixent wins FDA approval to treat asthma

Sanofi drug Dupixent wins FDA approval to treat asthma

(Reuters) – France’s Sanofi SA said on Friday eczema drug Dupixent was approved by the U.S. Food and Drug Administration as an additional maintenance therapy in patients with two types of asthma. Dupixent, co-developed with U.S.-based Regeneron, received approval to treat patients with eosinophilic asthma, a rare form of the disease, and those dependent on […]

Sanofi drug Dupixent wins US FDA approval to treat asthma

Sanofi drug Dupixent wins US FDA approval to treat asthma

Oct 19 (Reuters) – France’s Sanofi SA said on Friday eczema drug Dupixent was approved by the U.S. Food and Drug Administration as an additional maintenance therapy in patients with two types of asthma. Dupixent, co-developed with U.S.-based Regeneron, received approval to treat patients with eosinophilic asthma, a rare form of the disease, and those […]

FDA Rejects Canakinumab in CVD Prevention

FDA Rejects Canakinumab in CVD Prevention

It’s official: the FDA declined to approve canakinumab (Ilaris) for cardiovascular risk reduction on the strength of data from the CANTOS trial, according to drugmaker Novartis. “Based on the correspondence, the CANTOS data would not support labeling for the use of canakinumab as a targeted therapy for those patients with cardiovascular disease who achieved a […]

FDA unconvinced by Novartis pitch for canakinumab

FDA unconvinced by Novartis pitch for canakinumab

Dive Brief: Counterbalancing Novartis’ otherwise positive third quarter earnings, the Swiss pharma giant disclosed Thursday that regulators rejected an application aimed at getting its drug canakinumab approved for cardiovascular risk reduction. The rejection is noteworthy, given positive data from the Phase 3 CANTOS study that Novartis unveiled last year. Those results showed canakinumab not only outperformed placebo […]

FDA Panel Chair Warns of 'Abuse, Death' if Opioid Is Approved

FDA Panel Chair Warns of 'Abuse, Death' if Opioid Is Approved

In a rare move, the long-standing chair of the FDA advisory panel that last week recommended approval of an ultrapotent fentanyl analogue for severe acute pain is blasting the drug’s risk of “diversion, abuse, and death,” and urging the agency not to approve it. The statement from Raeford Brown, Jr., MD, chair of the Anesthetic […]

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