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FDA+ channel feed
Pharma industry praises Supreme Court's rejection of abortion pill challenge
11 months ago
Pharma
Law
Ultragenyx to seek accelerated approval for rare disease gene therapy
11 months ago
Cell/Gene Tx
Lilly, Eisai and Biogen seek more specifics in FDA guidance on early Alzheimer’s disease
11 months ago
Pharma
Updated: FDA funding would stay flat under House appropriations bill
11 months ago
Pharma
Sanders pushes subpoena vote to force testimony of Novo Nordisk exec on GLP-1 prices
11 months ago
Pharma
Law
Ipsen and Genfit secure FDA thumbs up for rare liver disease asset
11 months ago
Pharma
FDA advisors back Lilly’s Alzheimer’s drug, setting stage for approval after delay
11 months ago
Pharma
GSK stands by Orange Book patents that FTC has asked to rescind
11 months ago
Law
FDA establishes new meeting type to advise on drug safety technology
11 months ago
Pharma
GSK wins expanded FDA approval for RSV shot in at-risk adults ages 50 to 59
11 months ago
Pharma
FDA greenlights Geron’s imetelstat to treat anemia in certain cancer patients
11 months ago
Pharma
Italian antitrust agency investigates Novartis, Biogen and others over Lucentis biosimilar
11 months ago
Pharma
Senate fails to pass bill codifying access to contraception
11 months ago
Pharma
FDA explains why it rejected Vanda's insomnia application as company faces takeover bid
11 months ago
Pharma
Safety, efficacy and dosing questions linger for Lilly's Alzheimer's drug ahead of Monday adcomm
11 months ago
Pharma
Senate Finance Chair presses HHS to crack down on cybersecurity in wake of UnitedHealth attack
11 months ago
Pharma
Health Tech
FDA hands Chinese drug manufacturer a Form 483 noting employees destroyed documents
11 months ago
China
Manufacturing
Lykos’ MDMA-assisted therapy stumbles at adcomm amid questions about study, safety and abuse
11 months ago
Pharma
House lawmakers float transparency reforms for 340B program at hearing
11 months ago
Pharma
Updated: What the first five participants for FDA's Operation Warp Speed for rare diseases are tackling
11 months ago
Cell/Gene Tx
Fauci pushes back on pandemic criticisms before divided House panel
11 months ago
Pharma
Coronavirus
Agios plans thalassemia filing in US after unveiling data in transfusion-dependent patients
11 months ago
Pharma
FDA questions data on MDMA-based therapy in PTSD ahead of advisory committee
12 months ago
Pharma
CHMP recommends 14 new approvals, seven label expansions
12 months ago
Pharma
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