FDA: Page 22
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Sage, Biogen detail plans to get their newer depression drug approved
Following discussions with the FDA, the companies plan to submit zuranolone for approval in major depressive disorder and postpartum depression over the next roughly year and a half.
By Jacob Bell • Oct. 19, 2021 -
Win McNamee via Getty Images
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 -
Gabriel Kuchta via Getty Images
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 -
Jacob Bell/BioPharma Dive
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 -
Jens Schlueter via Getty Images
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 -
Sarah Silbiger via Getty Images
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 -
Sarah Silbiger via Getty Images
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 -
Spencer Platt via Getty Images
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. 7, 2021 -
Jon Cherry via Getty Images
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. 5, 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 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
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. 1, 2021 -
Sarah Silbiger via Getty Images
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 -
Sarah Silbiger via Getty Images
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 -
Antonio Masiello via Getty Images
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 -
Jens Schlueter via Getty Images
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 -
Courtesy of Eli Lilly
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 -
Mario Tama via Getty Images
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 -
Getty / Edited by BioPharma Dive
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 September meeting. Yet the FDA still appears wary, as suggested by new study holds for several genetic medicines.
By Ned Pagliarulo • Sept. 7, 2021 -
Courtesy of BioMarin Pharmaceutical
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. 7, 2021
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