Roche and Exelixis roll toward FDA approval with a melanoma cocktail

Damian Garde Roche and Exelixis are one step closer to FDA approval for their skin cancer-treating combination treatment, as the agency has accepted their application and promised a ...

Roche boasts new Lucentis approval for retinal damage in diabetes

Carly Helfand Roche now has another approval under its belt for eye drug Lucentis. And it’s in a market it can call its own: Lucentis is the first U.S.-approved treatment for ...

Merck wins FDA approval for Gardasil’s heir

Damian Garde Merck won the FDA's blessing for a next-generation HPV vaccine designed to usurp Gardasil, putting it in line for billions in revenue. FierceBiotech News

Merck’s next-gen Gardasil wins FDA approval

Tracy Staton Merck's Gardasil follow-up is here, meaning blockbuster sales are likely on the way. But they'll come at the expense of the previous iteration. FiercePharma ...

Valeant CEO touts R&D output with new dermatology approval

Carly Helfand Less than two weeks after losing longtime acquisition target Allergan–which happily sold itself to Actavis to dodge Valeant's hostile bid and the R&D cuts ...

Avanir’s odds for a timely drug approval aren’t looking so good

Damian Garde Avanir Pharmaceuticals, awaiting FDA approval for a new migraine treatment, got a letter from the agency pointing out flaws in submitted data, a regulatory hiccup that ...

FDA advisers spurn Novartis’ blood cancer drug, putting approval in doubt

Damian Garde Novartis' new multiple myeloma is treatment too risky to be approved, a group of FDA advisers voted, dealing a blow to the drugmaker and its hopes of launching the ...

FDA yanks Ranbaxy’s tentative approval for generic Nexium

Eric Palmer At about the same time that AstraZeneca CEO Pascal Soriot was telling investors its earnings had been boosted because no generic of blockbuster Nexium had appeared, Ranbaxy ...

Can J&J score sales with FDA’s new Olysio-plus-Sovaldi approval?

Tracy Staton Johnson & Johnson just scored a marketing goal: Its hepatitis C drug Olysio won FDA approval as part of a two-drug cocktail that also stars Gilead Sciences' Sovaldi. ...

Can Rockwell Medical win FDA approval for its dialysis drug?

Damian Garde FDA reviewers have little doubt that Rockwell Medical's iron-replacement treatment for dialysis patients met its goals in late-stage trials, but the company, seeking ...

Daiichi Sankyo’s new a-fib drug heads toward FDA approval and a crowded market

Damian Garde A panel of FDA advisers voted in favor of approving Daiichi Sankyo's irregular heartbeat treatment edoxaban, heralding its ability to break up blood clots and improving ...

Baxter wins FDA approval for another hemophilia drug

Damian Garde Baxter widened its hemophilia franchise on the eve of its breakup, winning FDA approval for a drug that treats a rare form of the bleeding disorder. FierceBiotech News
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