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Pharma channel feed
EMA rejects FDA-approved Parkinson's drug, signs off on Moderna vaccine use in adolescents ahead of FDA
4 years ago
FDA+
Novartis to pay nearly $178M in lawsuit over BRAF drug — and will be on the hook for royalty
4 years ago
6 top drugmakers offer perspectives on FDA's new covariates in RCTs guidance
4 years ago
R&D
Biogen has a shaky end to H1 with a $542M write-off adding to its woes — but analysts see big revenue ahead for Aduhelm
4 years ago
Biogen defends slow rollout of new Alzheimer's drug, criticizes negative media attention
4 years ago
Merck, Eisai notch full approval for Keytruda-TKI inhibitor combo in advanced endometrial cancer
4 years ago
FDA+
Inside Biogen's scramble to sell Aduhelm: Project 'Javelin' and pressure to ID as many patients as possible
4 years ago
In 60 days, most insurers will be required to cover HIV prevention drugs and related services with no cost-sharing
4 years ago
FDA+
How cozy is too cozy? FDA and Biogen offer up a test case
4 years ago
FDA+
FDA rejects professor’s petition seeking to pull ‘dangerous’ Otsuka kidney disease drug
4 years ago
FDA+
Terms of mega opioid settlement set to be disclosed this week — report
4 years ago
Merck KGaA fortifies its ‘site of the future’ with $319M research, staff training centers
4 years ago
FDA’s domestic biopharma inspections return to normal as agency faces backlog of 8,000+
4 years ago
FDA+
AstraZeneca earns another approval in jam-packed Chinese PD-(L)1 market, this time in late-stage lung cancer
4 years ago
China
Regeneron, already an institution in NY, earns Cuomo's backing for a $1.8B expansion at Tarrytown hive
4 years ago
Financing
Bristol Myers Squibb takes another late-stage loss for Opdivo-Yervoy combo in head and neck cancer
4 years ago
R&D
Pfizer settles EpiPen price hike lawsuits for $345M
4 years ago
Safety concerns push FDA adcomm to vote overwhelmingly against approval for FibroGen anemia drug
4 years ago
FDA+
Major health systems refuse to administer Aduhelm as top FDA leaders meet behind closed doors to talk with payers
4 years ago
FDA+
FDA chides Amgen over misleading banner ad for Neulasta
4 years ago
FDA+
FDA mulls regulatory action on Sprout's 'female Viagra' after adverse events spike
4 years ago
FDA+
In reversal, employers, union groups push for Congress to allow Medicare to negotiate drug prices
4 years ago
House committees kick off investigation into how Biogen's Aduhelm won approval
4 years ago
FDA+
CMS kicks off 9-month process on whether to limit coverage to Biogen's new Alzheimer's drug
4 years ago
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