Pharma & Biotech - Page 10

The U.S. Food and Drug Administration has issued a proposed rule that would create a streamlined registration pathway for distributed drug manufacturing establishments operating under a hub-and-spoke model. Under the current regulatory

Hengrui Pharma and Elevar Therapeutics have received a third complete response letter from the FDA for their camrelizumab and rivoceranib combination therapy. The rejection marks more than two years of regulatory setbacks

Lawmakers have introduced the first comprehensive bipartisan legislation to overhaul the 340B Drug Pricing Program since its creation more than three decades ago. US Representatives Jake Auchincloss, Scott Peters, and Dr. John

BioMarin has launched a three-episode video podcast series called “Why Do I Pheel This Way?” aimed at teens living with phenylketonuria, known as PKU. The campaign centres on real conversations about the

As access to GLP-1 medications widens across the United States, pharmacies are emerging as one of the most important pillars of long-term treatment success. Medicare’s expansion of GLP-1 access, including pathways toward

Bayer has agreed a €3 billion ($3.4 billion) equity deal with New York-based asset manager Apollo for a minority stake in its long-acting reversible contraceptives business. The German pharmaceutical giant will retain

TailorMed and Tennr have announced a platform integration designed to connect referral automation with medication affordability support for infusion centers and specialty pharmacies. The partnership pairs Tennr’s referral intake, documentation review, and

The FDA has approved the Padcev and Keytruda combination as the first platinum-free regimen for adult patients with muscle-invasive bladder cancer, regardless of cisplatin eligibility. The landmark approval marks a significant territorial

Pharmacy benefit manager reform is changing the commercial and operational environment for pharmaceutical manufacturers, even where it stops short of imposing direct obligations on them. Manufacturer programs do not operate in isolation,