FDA
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Woodcock steps in as acting FDA chief with crucial vaccine decisions ahead
Coronavirus vaccine reviews and drug approval backlogs will be just some of the challenges the longtime FDA veteran will face as the agency awaits President Joe Biden’s permanent pick.
By Jonathan Gardner • Jan. 21, 2021 -
Getty Images
Merck, Bayer win FDA approval for heart failure drug
The drugmakers could face an uphill battle, however, to market the medicine, which showed a more modest benefit than expected in a key study.
By Kristin Jensen • Jan. 20, 2021 -
5 questions facing the FDA in 2021
A new commissioner, high-stakes coronavirus vaccine reviews and a rising gene therapy workload will test the agency this year.
By Jonathan Gardner • Jan. 14, 2021 -
5 FDA approval decisions to watch in the 1st quarter
Bristol Myers and Bluebird are awaiting an FDA decision on their multiple myeloma cell therapy ide-cel, and could also soon get news on their lymphoma CAR-T drug liso-cel.
By Jonathan Gardner , Ned Pagliarulo , Ben Fidler • Jan. 05, 2021 -
Permission granted by University of Maryland School of Medicine
FDA says changing coronavirus vaccine dosing could put 'public health at risk'
In an unusual statement, FDA chief Stephen Hahn and top official Peter Marks opposed altering vaccination regimens without further evidence, calling proposals to do so "premature."
By Ben Fidler • Jan. 05, 2021 -
Jacob Bell
FDA grants approval to Ebola drug from Ridgeback
In a landmark study, fewer people given Ebanga died from Ebola virus infection than did those who received a control drug. Results from the trial also led to an OK for Regeneron's drug Inmazeb.
By Kristin Jensen • Dec. 22, 2020 -
Novartis
FDA delays decision on Novartis cholesterol therapy
The regulator declined to approve inclisiran, which Novartis acquired in its buyout of The Medicines Co., after agency staff weren't able to inspect a production facility in Europe.
By Ned Pagliarulo • Dec. 21, 2020 -
Moderna
Moderna's first FDA clearance brings the US a second coronavirus vaccine
The FDA's emergency authorization of the biotech's shot bolstered a nascent immunization campaign in the U.S.
By Ben Fidler • Dec. 18, 2020 -
Moderna
FDA panel endorses Moderna's coronavirus vaccine
A group of independent experts supported use of the biotech's shot, which is likely to receive an emergency authorization from the FDA within days.
By Ned Pagliarulo • UPDATED: Dec. 17, 2020 at 6:02 p.m. -
A play-by-play of the FDA meeting on Moderna's coronavirus vaccine
Members of an independent advisory committee voted 20-0 to recommend use of the company's experimental shot, paving the way for an emergency authorization from the FDA.
By Ben Fidler , Jonathan Gardner , Ned Pagliarulo • UPDATED: Dec. 17, 2020 at 5:42 p.m. -
Moderna
FDA scientists back safety, efficacy of Moderna's coronavirus vaccine
A review by agency staff affirmed the strongly positive results Moderna reported from a large Phase 3 study, clearing the way for a possible emergency authorization in the coming days.
By Ned Pagliarulo • Dec. 15, 2020 -
Regeneron
Regeneron pauses studies of a key cancer drug, citing safety concerns
The FDA flagged a high rate of cytokine release syndrome, a potentially dangerous side effect, in trials of a lymphoma drug Regeneron is developing.
By Kristin Jensen • Dec. 15, 2020 -
Courtesy of BioNTech
In historic decision, FDA clears coronavirus vaccine from Pfizer, BioNTech
The vaccine was the first authorized for emergency use in the U.S. after a large study showed it to be highly protective against COVID-19, a landmark moment amid a worsening pandemic.
By Jonathan Gardner • Dec. 11, 2020 -
FDA advisers back Pfizer, BioNTech vaccine, clearing way for emergency approval
In a statement Friday, FDA Commissioner Stephen Hahn said the agency would "rapidly work toward finalization and issuance" of an authorization for the shot.
By Ned Pagliarulo • UPDATED: Dec. 11, 2020 at 10:32 a.m. -
Courtesy of BioNTech
A play-by-play of the historic FDA meeting on Pfizer and BioNTech's coronavirus vaccine
A panel of vaccine and infectious disease experts met Thursday to public vet the drugmaker's study results, eventually voting 17-4 in support of the vaccine after nearly nine hours of discussion.
By Ben Fidler , Jonathan Gardner , Ned Pagliarulo • UPDATED: Dec. 9, 2020 at 7:01 p.m. -
Courtesy of BioNTech
FDA scientists appear supportive of Pfizer, BioNTech's coronavirus vaccine
Agency staff didn't raise any red flags in their review of the companies' study results, documents released ahead of a key advisory committee meeting Thursday show.
By Ned Pagliarulo • UPDATED: Dec. 8, 2020 at 2:48 p.m. -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
Regeneron COVID-19 drug, used to treat Trump, cleared for emergency use
The drug is the second antibody-based treatment to win FDA emergency authorization this month, though supplies of both are very limited.
By Ben Fidler • Nov. 22, 2020 -
Pfizer, BioNTech ask FDA for emergency approval of coronavirus vaccine
The companies expect immunizations with their shot, if approved, could begin in high-risk groups by the middle to end of December.
By Ned Pagliarulo • UPDATED: Nov. 20, 2020 at 6:11 p.m. -
Permission granted by Bristol-Myers Squibb
FDA delays decision on Bristol Myers cell therapy, putting Celgene deal payouts in jeopardy
Travel restrictions have made it difficult for the regulator to inspect a plant used to make the treatment, meaning the drugmaker could miss a deadline critical to former Celgene shareholders.
By Jonathan Gardner • Nov. 17, 2020 -
FDA unexpectedly rejects Alkermes schizophrenia drug, citing manufacturing concerns
Though Alkermes believes it can quickly resolve the issues cited by the agency, the complete response letter nonetheless delays approval of a drug that's critical to the company's hopes of a turnaround.
By Kristin Jensen • Nov. 17, 2020 -
National Institute of Allergy and Infectious Disease. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from https://www.flickr.com/photos/nihgov/49655318098/in/album-72157713108522106/.
Eli Lilly wins FDA emergency clearance for COVID-19 antibody drug
The regulator approved Lilly's synthetic antibody treatment for emergency use, but short supplies and logistical challenges could limit its initial impact.
By Ben Fidler • Nov. 09, 2020 -
Jacob Bell / BioPharma Dive
5 takeaways from the FDA's high-stakes meeting for Biogen's Alzheimer's drug
The expert panel's decidedly negative vote on aducanumab raised questions about the drug's future, as well as the credibility of the FDA.
By Jacob Bell , Ned Pagliarulo , Ben Fidler • Nov. 09, 2020 -
Getty Images
FDA advisers vote against Biogen's Alzheimer's drug, leaving its future in doubt
In a tense meeting, a group of experts found Biogen and the FDA's case for aducanumab unpersuasive, voting overwhelmingly against the drug.
By Jacob Bell , Jonathan Gardner , Ned Pagliarulo • UPDATED: Nov. 7, 2020 at 7:15 p.m. -
Courtesy of BioMarin Pharmaceutical
BioMarin, stung by FDA rejection, pressed on path forward for 2 key drugs
Roctavian, the biotech's hemophilia gene therapy, was turned down by the FDA in August, while an important rare disease drug is now under review.
By Ned Pagliarulo • Nov. 06, 2020 -
Regeneron
Who would get Regeneron's COVID-19 antibody treatment?
The drug, now being considered for emergency clearance by the FDA, seems to work best in patients whose immune systems haven't responded to infection. Fast antibody testing, however, is spotty.
By Jonathan Gardner • Nov. 05, 2020
