FDA: Page 24
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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 -
Jacob Bell/BioPharma Dive
Gene therapy safetyAt 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. 3, 2021 -
Sarah Silbiger via Getty Images
With safety worries mounting, FDA limits who can take certain immune-regulating drugs
The agency has new rules for who can take Pfizer's Xeljanz, Eli Lilly's Olumiant or AbbVie's Rinvoq after a large study raised concerns about the safety of so-called JAK inhibitors.
By Jacob Bell • Sept. 1, 2021 -
Sarah Silbiger via Getty Images
What to expect at the FDA's two-day meeting on gene therapy safety
A group of advisers convened by the agency began the two-day meeting Thursday with a discussion of cancer risk to AAV gene therapy.
By Ned Pagliarulo , Ben Fidler • Sept. 1, 2021 -
Getty Images
Top FDA vaccine officials to leave agency as decision on COVID-19 boosters looms
In a memo to agency staff, acting FDA head Janet Woodcock expressed confidence in the team that will remain in place under the leadership of CBER director Peter Marks.
By Ben Fidler • Updated Aug. 31, 2021 -
FDA scrutiny, Merck approval lead Roche to pull Tecentriq in breast cancer
While FDA advisers voted in April to keep Tecentriq available for use in triple-negative breast cancer, the Swiss pharma said changes in how the disease is treated spurred it to withdraw the indication.
By Jonathan Gardner • Aug. 30, 2021 -
Mario Tama via Getty Images
FDA grants full approval to Pfizer, BioNTech's coronavirus vaccine
During a press briefing, FDA officials expressed optimism the decision could help boost vaccination rates, but warned against off-label use — particularly in children, for which clinical tests are currently underway.
By Jonathan Gardner • Updated Aug. 23, 2021 -
Win McNamee via Getty Images
Biden said to rule out Woodcock as permanent FDA chief
A published report indicated the agency's longtime drug reviewer is no longer in consideration for the role, leaving the FDA's top job in flux as key decisions near on coronavirus booster shots and vaccinations for children.
By Jonathan Gardner • Aug. 20, 2021 -
Courtesy of Eli Lilly
FDA approves Lilly, Boehringer diabetes drug for heart failure
The expanded clearance in heart failure with reduced ejection fraction is expected to boost sales of the drug, called Jardiance.
By Kristin Jensen • Aug. 19, 2021 -
Jens Schlueter via Getty Images
US to offer coronavirus boosters to all Americans in aggressive plan to counter delta's spread
Top U.S. health officials defended their controversial decision to give all Americans a third shot, predicting that signs of lower efficacy against infection could lead to reduced protection against worse outcomes.
By Ned Pagliarulo , Ben Fidler • Updated Aug. 18, 2021 -
Courtesy of Eli Lilly
Lilly, preparing Alzheimer's drug plans, forms new neuroscience unit in company restructure
Lilly Bio-Medicines will be split into separate neuroscience and immunology groups, while the Loxo cancer research division will merge with Lilly Oncology.
By Jonathan Gardner • Aug. 17, 2021 -
Merck wins approval for cancer drug acquired in 2019 biotech buyout
The FDA cleared Welireg, which Merck picked up in its $1 billion deal for Peloton Therapeutics, to treat tumors associated with a rare genetic disease.
By Ned Pagliarulo • Aug. 16, 2021
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