FDA: Page 36
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After FDA rejection, Immunomedics tries again with breast cancer drug
Sacituzumab govitecan would be Immunomedics' first commercial product if the biotech succeeds on its second attempt to convince the FDA.
By Andrew Dunn • Dec. 3, 2019 -
FDA denies Lexicon bid to reverse diabetes drug rejection
The biotech, which lost big pharma partner Sanofi earlier this year, isn't giving up, announcing plans to escalate its dispute to a higher division within the FDA.
By Ned Pagliarulo • Dec. 2, 2019 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
Before 2019 closes, the FDA has 3 key approval decisions to make
The agency has been on an approval tear lately, and more may come as reviews for drugs from Amarin, Allergan and Intra-Cellular wrap up.
By Jacob Bell • Nov. 27, 2019 -
Global Blood's sickle cell drug wins FDA approval, joining Novartis' Adakveo
A list price of roughly $10,000 a month puts Global Blood's Oxbryta slightly higher than what Novartis' Adakveo will cost.
By Jonathan Gardner • Updated Nov. 26, 2019 -
FDA approves new epilepsy therapy, a first for Korea's SK Life Science
The Korean drugmaker has steadily grown its U.S. pharmaceutical presence over the past decade, now capped by an OK for Xcopri.
By Andrew Dunn • Nov. 22, 2019 -
Calquence OK boosts AstraZeneca's challenge to Imbruvica
The new FDA approval expands Calquence's use into a more common blood cancer, although doctors have already been prescribing it for that disease.
By Jonathan Gardner • Nov. 22, 2019 -
Novartis sickle cell drug wins FDA approval
Adakveo is only the second treatment approved in two decades for the painful blood clots caused by the rare disease.
By Jonathan Gardner • Nov. 15, 2019 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
BeiGene FDA cancer drug nod seen as breakthrough for Chinese biopharma
The drug, branded as Brukinsa, will go up against J&J and AbbVie's Imbruvica and AstraZeneca's Calquence in lymphoma.
By Jonathan Gardner • Nov. 15, 2019 -
FDA expert panel unanimously recommends Amarin's Vascepa in closely-watched vote
Debates about side effects and the mineral oil placebo failed to dissuade any member of the FDA's advisory committee from voting against an expanded indication.
By Andrew Dunn • Nov. 14, 2019 -
Jacob Bell/BioPharma Dive
Mylan plant warned by FDA over valsartan manufacturing
Regulators said Mylan's ways of identifying, testing and handling raw materials at an Indian plant aren't enough to prevent contamination.
By Kristin Jensen • Nov. 14, 2019 -
Jacob Bell/BioPharma Dive
FDA documents appear to clear Amarin path to wider heart drug approval
The documents, released ahead of Thursday's advisory panel meeting, suggest the FDA is open to an expanded label for Vascepa, Amarin's fish oil-derived pill.
By Ned Pagliarulo • Nov. 12, 2019 -
FDA
Regenxbio, stung by trial hold on gene therapy, sues FDA
The biotech seeks to overturn clinical holds placed by the FDA on two gene therapy programs, arguing the agency action was "arbitrary and capricious."
By Ned Pagliarulo • Nov. 11, 2019 -
Jacob Bell/BioPharma Dive
FDA approves first drug for anemia tied to rare blood disorder
Developed by Celgene and biotech partner Acceleron, Reblozyl is one of five drugs Bristol-Myers Squibb highlighted in its $74 billion buyout of Celgene.
By Ned Pagliarulo • Updated Nov. 8, 2019 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
Sarepta tries softer approach to resolve FDA setback
Departing from the combative tack taken by Sarepta with Exondys 51, CEO Doug Ingram appears to be reading from a new playbook in handling Vyondys 53's rejection.
By Jonathan Gardner • Nov. 8, 2019 -
Third Neulasta biosimilar on its way as Sandoz wins long-delayed FDA approval
Novartis' drug will be third to market, but copycat drugs have already taken a chunk of the market away from Amgen's branded version.
By Jonathan Gardner • Nov. 5, 2019 -
As fateful FDA review nears, Amarin makes case for Vascepa
Company CEO John Thero said he expects an FDA advisory panel will ask "intentionally tough" questions and challenge Vascepa's data at a meeting set for Nov. 14.
By Andrew Dunn • Nov. 5, 2019 -
Aveo's cancer drug runs into a skeptical FDA
The regulator told the Cambridge, Massachusetts-based biotech to hold off on filing its cancer drug, sending shares in the company down 40%.
By Andrew Dunn • Nov. 4, 2019 -
Stephen Hahn, top MD Anderson official, will be next FDA chief
After more than a month of speculation, Trump selected the oncologist and MD Anderson executive to be his next commissioner.
By Ned Pagliarulo • Nov. 1, 2019 -
Jacob Bell/BioPharma Dive
FDA blames market failures for drug shortages
High-profile shortages of drugs like EpiPen and the chemotherapy vincristine have brought attention to a chronic problem, one that's spurred in part by what the FDA termed a "broken marketplace."
By Kristin Jensen • Oct. 31, 2019 -
Novartis gene therapy ambitions dealt another blow by FDA hold on Zolgensma
A partial trial suspension threatens to delay the gene therapy's expansion into older children, as the FDA works through safety findings from an animal study.
By Jonathan Gardner • Oct. 30, 2019 -
FDA panel backs withdrawal of Amag drug to prevent preterm birth
An advisory committee narrowly recommended the FDA rescind approval for Makena, which showed no benefit in a confirmatory study.
By Ned Pagliarulo • Oct. 30, 2019 -
Vertex wins speedy approval for cystic fibrosis triplet
With Trikafta cleared by the Food and Drug Administration, Vertex estimates its drugs can treat as much as 90% of patients with the lung condition.
By Jacob Bell • Oct. 21, 2019 -
Courtesy of Eli Lilly
Lilly's 1-drug migraine business gets support with new approval
An OK for Reyvow, an acute migraine drug, complements Lilly's preventive therapy Emgality and could strengthen the company's footing in an increasingly crowded market.
By Ned Pagliarulo • Oct. 11, 2019 -
Jacob Bell/BioPharma Dive
Australian drugmaker's decade-long journey ends in FDA approval
U.S. regulators cleared Clinuvel's Scenesse for a rare skin disease that causes sensitivity to light.
By Ned Pagliarulo • Oct. 9, 2019 -
Former FDA chief Gottlieb predicts Trump-pitched pricing model easy to game
"I don't want to give too much away, because I'll tell people how to game around this," said the former commissioner, who now sits on Pfizer's board.
By Andrew Dunn • Oct. 8, 2019
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