FDA

Biden reportedly weighing former FDA chief Califf to again lead agency

The Washington Post reported the administration was "closing in" on Califf, citing sources. The White House declined to comment and Califf could face opposition from Senate Democrats if chosen. 

By Ricky Zipp • Oct. 15, 2021

FDA advisers unanimously back Moderna booster shot for many Americans

But the committee members remain opposed to broad use of boosters in healthy young adults, for whom the benefits of an additional shot are less clear.

By Shoshana Dubnow • Oct. 14, 2021

Merck advantage grows as FDA approves Keytruda for first-line cervical cancer

The company's immunotherapy is the only drug of its type cleared for advanced cervical cancer. Others are being tested, however. 

By Ned Pagliarulo • Oct. 14, 2021

NIH study finds mixing COVID-19 boosters increases immune response

Results suggested Pfizer's and Moderna's vaccines may serve as a more potent booster for those who initially received Johnson & Johnson's shot, although data are limited and preliminary.

By Shoshana Dubnow • Oct. 13, 2021

FDA staff take neutral stance on Moderna, J&J boosters ahead of two-day meeting

Advisers are discussing an authorization of Moderna's booster on Thursday, with a vote on recommendations to the FDA expected this afternoon. 

By Shoshana Dubnow • Oct. 13, 2021

Allogene cell therapy trials halted by FDA after unexpected safety finding

Researchers found evidence of a "chromosomal abnormality" in one patient treated with Allogene's CAR-T cell therapy, spurring the clinical hold and an investigation.

By Ben Fidler • UPDATED: Oct. 8, 2021 at 9:09 a.m.

Pfizer officially seeks FDA clearance for coronavirus vaccine in kids

The companies' application starts a pressure-packed FDA review that could open up COVID-19 shots for tens of million Americans between the ages of 5 and 11.

By Shoshana Dubnow • Oct. 07, 2021

J&J asks FDA to clear booster dose of its coronavirus vaccine

The agency is holding an advisory committee meeting on Oct. 15 to discuss a second dose of J&J's shot, as well as boosting with different vaccines.

By Ned Pagliarulo • Oct. 05, 2021

Gilead wins approval of CAR-T therapy in adult leukemia

Tecartus, Gilead's second cell therapy on the market, is the first CAR-T treatment to be cleared for use in people older than 18 with ALL.

By Ned Pagliarulo • UPDATED: Oct. 4, 2021 at 12:29 p.m.

5 FDA approval decisions to watch in the fourth quarter

Regulators face key decisions on COVID-19 shots for children and boosters for Moderna's and J&J's vaccines. Other closely watched drugs for multiple myeloma and depression are under review, too.

By Ben Fidler , Jonathan Gardner , Jacob Bell , Ned Pagliarulo , Shoshana Dubnow • Oct. 01, 2021

Top FDA official takes over vaccine office as agency weighs COVID-19 shots for kids

Peter Marks will lead the FDA's vaccine team earlier than expected, enabling departing reviewers Marion Gruber and Phil Krause to "have time to transition," he wrote in an email.

By Ben Fidler • Sept. 28, 2021

Eisai, Biogen to test FDA by asking for approval of second Alzheimer's drug

The Japanese pharma and Biogen partner is filing an application for an accelerated OK of lecanemab, which works similarly to the companies' controversially cleared Aduhelm.

By Ned Pagliarulo • UPDATED: Sept. 28, 2021 at 7:47 a.m.

FDA green lights booster dose of Pfizer vaccine for older, more vulnerable Americans

The authorization is more narrow than envisioned by the Biden administration last month, but still makes millions of Americans eligible for a third Pfizer shot.

By Shoshana Dubnow • Sept. 22, 2021

Incyte eczema drug wins FDA OK, but with safety warning

A topical cream formulation of the drug in Incyte's top-selling product could help the company expand. The black box warning, though, might limit use.

By Kristin Jensen • Sept. 22, 2021

Seagen, Genmab win speedy FDA approval for cervical cancer drug

Tivdak, a type of drug known as an antibody-drug conjugate, is the fourth approved medicine for Seagen and its third to reach market since December 2019.

By Jonathan Gardner • Sept. 21, 2021

Pfizer says coronavirus vaccine is safe and spurs immune response in children

The results position Pfizer and BioNTech to seek clearance in children as young as 5 years old. But the companies haven't yet shared data on a rare heart inflammation associated with their shot that's a concern for regulators.

By Jonathan Gardner • Sept. 20, 2021

FDA approves first biosimilar of top-selling eye drug Lucentis

The approval of Byooviz, developed by Samsung Bioepis and set to be sold by Biogen, comes amid a slowdown in biosimilar clearances from the agency.

By Shoshana Dubnow • Sept. 20, 2021

FDA advisers support booster dose of Pfizer vaccine in older or high-risk adults

In a back-and-forth meeting Friday, the committee opposed clearing a third shot widely for use in people older than 16, but agreed the benefits outweighed the risks for adults over 65 or those at risk of severe COVID-19.

By Shoshana Dubnow , Ned Pagliarulo • UPDATED: Sept. 17, 2021 at 6:56 p.m.

Lilly's COVID-19 antibody cleared by FDA for post-exposure prevention

The expanded authorization comes amid surging demand for antibody treatments, particularly in states with lower rates of coronavirus vaccination.

By Ned Pagliarulo • Sept. 17, 2021

Takeda wins FDA approval for targeted lung cancer drug

Exkivity follows Johnson & Johnson's Rybrevant on the market for treating lung tumors harboring specific mutations in the EGFR gene. Unlike J&J's drug, however, Takeda's is given orally. 

By Kristin Jensen • Sept. 16, 2021

After talks with FDA, a biotech prepares to submit its closely watched ALS drug

Executives at Amylyx Pharmaceuticals said that based on the agency's recent feedback, they will soon ask for approval of AMX0035 — a change of plans from earlier this year. 

By Jacob Bell • Sept. 15, 2021

Departing FDA officials, WHO leaders argue against broad rollout of COVID-19 booster shots

Marion Gruber and Philip Krause, two top FDA vaccine reviewers who are unexpectedly departing this fall, joined senior WHO officials in saying booster vaccine doses are not yet widely needed. 

By Ned Pagliarulo • Sept. 13, 2021

Gene therapy safety

'The sky is not falling.' Cautious optimism follows FDA meeting on gene therapy risks

Wall Street analysts expect little impact on biotech developers after an inconclusive discussion last week. Yet the FDA still appears wary, as shown by a new hold on a BioMarin rare disease treatment.

By Ned Pagliarulo • Sept. 07, 2021

Gene therapy safety

FDA halts tests of BioMarin drug amid heightened focus on gene therapy safety

On the heels of a two-day FDA meeting in which experts debated the risks of gene therapy, the biotech said its early-stage PKU treatment was associated with cancer in mice.

By Ben Fidler • Sept. 07, 2021

Gene therapy safety

At FDA meeting, gene therapy experts wrestle with field's blindspots

A panel convened by the regulator suggested ways to make gene therapy research safer, but struggled to propose broader recommendations.

By Ned Pagliarulo , Ben Fidler • Sept. 03, 2021