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Regulatory Intelligence & Drug Approvals4 weeks ago5 FDA decisions to watch in the fourth quarter of 2026
The next three months will feature anticipated decisions on a new kind of cancer immunotherapy, as well as medicines important to the futures of Roche, GSK...
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Regulatory Intelligence & Drug Approvals4 weeks agoImporting Human Drugs
FDA importing requirements for human drug products,
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Regulatory Intelligence & Drug Approvals4 weeks agoSTAT+: Invivyd’s pursuit of a Covid vaccine alternative gets a lift, but an FDA hurdle may await
The small biotech company Invivyd is developing an injectable, low-dose monoclonal antibody to protect against Covid.
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Regulatory Intelligence & Drug Approvals1 month agoU.S. Food and Drug Administration Approves Expanded Indication for Bristol Myers Squibb’s Camzyos (mavacamten) for the Treatment of Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM) in Adults and Pediatric Patients*
PRINCETON, N.J.--(BUSINESS WIRE) September 30, 2026 -- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Camzyos (mavacamten) for...
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Regulatory Intelligence & Drug Approvals1 month agoWitty, Sharpless join Hatteras. Plus: PhRMA picks Cantor to succeed Ubl
BIOCENTURY | MANAGEMENT TRACKSWITTY, SHARPLESS JOIN HATTERAS. PLUS: PHRMA PICKS CANTOR TO SUCCEED UBLAnd a CEO change at Pharming; FDA recruiting people with expertise for advisory...
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Regulatory Intelligence & Drug Approvals1 month agoFDA starts review of Roche’s multiple sclerosis pill
The FDA previously hadn’t ever accepted an application of a drug like fenebrutinib in two major forms of MS. But safety questions still hang over Roche’s...
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Regulatory Intelligence & Drug Approvals1 month agoAtara, Pierre Fabre resubmit twice-rebuffed cell therapy after FDA flips again
Ebvallo, which Pierre Fabre Pharmaceuticals and Atara Biotherapeutics are proposing to treat a posttransplant complication, joins a wave of rejected or discouraged therapies on which the...
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Regulatory Intelligence & Drug Approvals1 month agoPhRMA names next CEO; Pierre Fabre takes third swing at Ebvallo approval
A former congressman will take over for prominent lobbyist Steve Ubl. Elsewhere, recent buyout deals paid dividends for Mirum and AbbVie.
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Regulatory Intelligence & Drug Approvals1 month agoI-DXd withdrawal thins October PDUFA calendar
BIOCENTURY | DATA BYTEI-DXD WITHDRAWAL THINS OCTOBER PDUFA CALENDARFive FDA decisions remain after BLA withdrawal and two sNDA approvals
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Regulatory Intelligence & Drug Approvals1 month agoThe Center for Research on Complex Generics
FDA awards a 5-year grant to the University of Maryland and the University of Michigan to establish a Center for Research on Complex Generics (CRCG).
Opentrons Raises $40M in Series E to Expand Its Robotics, Software, Data Infrastructure
100 Million-Cell AI-Ready Dataset with Single-Cell and Proteomic Data Created by Parse and Nomic
No Nonsense: David Liu Lauds Progress in Disease-Agnostic Gene Editing at ESGCT
Novartis buys Synnovation’s PI3Kα inhibitors for $3 billion
Novartis to pay $2B upfront to take next-gen PI3Kα inhibitor from Synnovation
