AstraZeneca to Withdraw Andexxa Following FDA Risk Assessment
AstraZeneca is set to withdraw its bleeding reversal agent Andexxa from the market in the…
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EMA Management Board: Highlights of December 2025 Meeting
The European Medicines Agency (EMA) Management Board convened in December 2025, marking a pivotal moment…
Catalent Receives Two Form 483s for Maryland Gene Therapy Facilities
Catalent has recently been issued two Form 483s by the FDA concerning its gene therapy…
Endpoints at JPM 2026: Key Discussions on the Horizon
As the JP Morgan Healthcare Conference approaches, industry stakeholders are gearing up for critical discussions…
Novo obesity partner nabs Pfizer vet as CBO; CureVac’s leadership clears out as BioNTech takes over
Novo Nordisk’s obesity-focused partner has appointed a former Pfizer executive as its Chief Business Officer,…
FDA Outlines Manufacturing Concerns with Elevidys at Catalent’s Maryland Site
The FDA has raised significant concerns regarding the manufacturing processes for Elevidys at Catalent’s Maryland…
BioMarin makes its largest-ever transaction, paying $4.8B for fellow rare disease drugmaker Amicus
BioMarin Pharmaceutical has executed a landmark transaction, acquiring Amicus Therapeutics for $4.8 billion, marking the…
BMS’ Cobenfy TV ad is latest target of FDA untitled letter spree
The FDA has recently issued an untitled letter addressing the direct-to-consumer advertising of Bristol Myers…
Eli Lilly Submits NDA for Oral GLP-1RA Orforglipron, Targeting Obesity Management
Eli Lilly has submitted a new drug application (NDA) to the FDA for orforglipron, an…
FDA’s National Priority Voucher Pilot Program Promises Dramatic Reduction in Review Times
The FDA’s Commissioner’s National Priority Voucher (CNPV) Pilot Program is set to transform the drug…