The FDA has issued a complete response letter to Summit Therapeutics, derailing the immediate U.S. launch of a drug class ...
Genentech has unlocked a new chapter in its patient-forward “Life Doesn’t Wait” campaign for hemophilia A drug Hemlibra with ...
Earlier this year, AZ fired another shot in bladder cancer when Imfinzi was cleared by the FDA alongside Bacillus ...
The FDA has quietly shelved the Commissioner’s National Priority Voucher (CNPV) pilot program, a controversial speedy review ...
With Lantheus in the process of being bought out by fellow radiopharmaceutical player Curium, the company is offloading its ...
Eli Lilly could soon see two label expansions for Foundayo, it’s oral GLP-1, in swift succession: In September, the drugmaker ...
With a positive classification from the DEA paving the way for Orzeyful’s U.S. launch on Thursday, Takeda is charting new ...
Following a back-and-forth with the Pentagon this year, contracting juggernaut WuXi AppTec appears to have largely evaded its ...
Summit Therapeutics is gearing up for ivonescimab’s high-stakes FDA decision without its chief commercial officer (CCO) ...
In a series of regulatory wrist-slaps now made public, the FDA has taken three manufacturers to task over record request ...
AstraZeneca’s $1.5 billion cost-savings drive has started to take a toll on its U.S. workforce. | AstraZeneca’s $1.5 billion cost-savings drive has started to take a toll on its U.S. workforce. The ...
Merck KGaA just secured an FDA approval for its new once-daily oral colony stimulating factor-1 receptor (CSF-1R) inhibitor, ...
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