FDA

Epizyme drug granted approval by FDA for rare cancer

Five years after after buying back rights from Eisai, Epizyme won approval for its first-ever drug.
By Ned Pagliarulo • Jan. 23, 2020
While expected, Intercept's approval delay adds to NASH uncertainty

An upcoming FDA advisory meeting will be a key test for Intercept's ambitions to become the first drugmaker with an approved therapy for the liver disease.
By Jacob Bell • Jan. 17, 2020
Nektar quickly drops opioid drug after FDA panel rejection

After a decade of research, the biotech said it will withdraw its application for oxycodegol and make no further investment in the drug.
By Kristin Jensen • Jan. 15, 2020
Ultragenyx boosted by trial data for 2nd gene therapy

One analyst called the results, which sparked a 30% jump in Ultragenyx's stock price, better than expected. The biotech is now preparing a Phase 3 trial.
By Jonathan Gardner • Jan. 10, 2020
5 trends to watch at the FDA in 2020

With Stephen Hahn confirmed as commissioner, the regulator is better positioned to more firmly address political pressures and a rising tide of complex medicines.
By Jonathan Gardner • Jan. 09, 2020
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Risk-based quality management: Your key to safety and effectiveness

Why is the FDA and other regulators urging clinical trial sponsors to rethink the way they design and run clinical trials?
5 FDA approval decisions to watch in the 1st quarter

Aimmune's peanut allergy therapy and Esperion's cholesterol offering could be among the new drugs cleared in the first few months of the new decade.
By Jacob Bell • Jan. 02, 2020
AstraZeneca and Merck's Lynparza cleared by FDA for pancreatic cancer

The pill is the second targeted treatment approved for pancreatic cancer, although its use is limited to only a small share of patients.
By Jonathan Gardner • Dec. 30, 2020
Intra-Cellular approval keeps focus on FDA's neuroscience review process

Lumateperone, to be sold as Caplyta, had conflicting results in late-stage trials. Its approval suggests the FDA is using a "glass half full lens" to review neuroscience drugs, said one analyst.
By Jacob Bell • Dec. 23, 2019
FDA rejects GSK's HIV therapy in setback to two-drug strategy

The British drugmaker said the Complete Response Letter was unrelated to product safety, but the delay could hamper GSK's bid to challenge rival Gilead.
By Andrew Dunn • Dec. 23, 2019
Daiichi, AstraZeneca breast cancer drug joins bumper crop of early FDA approvals

AstraZeneca bet big on the Japanese pharma's HER2-targeting therapy, a gamble that paid off with a speedy approval for Enhertu.
By Jonathan Gardner • UPDATED: Dec. 23, 2019 at 10:35 a.m.
FDA approves Merck's Ebola vaccine, a historic first against deadly virus

The pharma giant has already given 275,000 doses of the vaccine to fight an outbreak in central Africa. Other drugmakers, including J&J and Regeneron, are also developing vaccines.
By Andrew Dunn • Dec. 20, 2019
Amarin secures long-sought FDA nod, boosting sales hopes for heart pill

The company will target as many as 80,000 doctors with a doubled salesforce for Vascepa, CEO John Thero said Monday in an interview.
By Andrew Dunn • UPDATED: Dec. 16, 2019 at 9:51 a.m.
Biogen's Alzheimer's drug gets caught in Sarepta's spotlight

The unexpected approval of Sarepta's Vyondys 53 has some wondering how lenient the FDA might be in reviewing aducanumab. Others, however, see little impact.
By Jacob Bell • Dec. 13, 2019
Hahn confirmed as FDA head, to lead agency as drug review process is tested

Stephen Hahn, an oncologist and former MD Anderson executive, is set to confront several pressing issues, including the rigor of the FDA's approvals.
By David Lim , Andrew Dunn • Dec. 13, 2019
In stunning twist, FDA approves Sarepta's Duchenne drug it rejected

Following an August rejection of Vyondys 53, Sarepta appealed the FDA's decision through a formal dispute resolution process that led to the agency's about-face.
By Ned Pagliarulo , Jonathan Gardner • Dec. 12, 2019
New approval for Roche's Tecentriq heats up lung cancer battle with Keytruda

One Wall Street analyst expects the FDA's OK will help Tecentriq outpace Bristol-Myers Squibb's Opdivo in 2020 in the non-small cell lung cancer market.
By Jonathan Gardner • Dec. 04, 2019
Trump FDA nominee Hahn advanced by Senate HELP Committee

Senators voted 18-5 to move Hahn's nomination to a full Senate vote. Sen. Patty Murray cited concerns over Hahn's position on e-cigarettes in voting no.
By David Lim • Dec. 03, 2019
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. 03, 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. 02, 2019
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 at 10:04 a.m.
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