Eli Lilly has $1.5 billion worth of pre-launch inventory for its weight-loss drug, orforglipron, ahead of FDA decision in ...
The news is the latest sign of the FDA’s heightened scrutiny of vaccines under Health Secretary Robert F. Kennedy Jr.
Prescription Drug User Fee Act (PDUFA) target action date set for September 28, 2026If approved, Ameluz® would be the first and only PDT ...
Dealbreaker on MSN
Moderna says FDA refusal to review mRNA flu vaccine contradicts federal rules, prior guidance
The FDA’s refuse-to-file letter cited no safety or efficacy concerns for Moderna’s influenza vaccine.
The FDA has accepted a sNDA for Ameluz topical gel, used in combination with the RhodoLED red-light lamp series, for superficial basal cell carcinoma treatment.
"The FDA rejected Moderna's application for filing because the company refused to follow very clear FDA guidance from 2024 to ...
FDA refuses Moderna's mRNA flu vaccine application, citing inadequate study design, as the company disputes decision, saying it contradicts prior FDA guidance.
In its main clinical trial, mRNA-1010 was shown to be 26.6% more effective than the comparator flu shot in adults aged 50 ...
The Food and Drug Administration on Wednesday defended its rejection of Moderna’s mRNA-based flu vaccine application, saying ...
BridgeBio Pharma Inc. BBIO stock is surging on Thursday and nearing the upper end of its 52-week range of $28.33-$84.94, ...
Feb 12 (Reuters) - Eli Lilly had $1.5 billion worth of pre-launch inventory of its experimental oral weight-loss drug, a ...
Presented by the Coalition to Strengthen America’s Healthcare{beacon} Health Care Health Care The Big Story FDA refuses ...
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