News

BioPharma Dive16m
FDA takes major step to ease access to CAR-T therapy
The agency removed some onerous requirements for the complex cancer drugs and reduced restrictions on patients’ ...
CURE55m
FDA Approves CAR T Therapy Label Updates Across Various Blood Cancers
Label updates have been approved by the FDA for the CAR T-cell therapies Breyanzi and Abecma in large B cell lymphoma and ...
MPR1h
FDA Removes REMS, Reduces Monitoring Requirements For Breyanzi and Abecma
The Breyanzi REMS program and the Abecma REMS program were established due to the risk of cytokine release syndrome and neurologic toxicities.
FDA Eases Rules For Bristol Myers' Cell Therapies For Blood Cancers
FDA approved label changes for Breyanzi and Abecma, easing access by reducing monitoring rules and eliminating REMS safety ...
Fierce Pharma1h
FDA removes CAR-T access barrier in move set to boost cancer immunotherapy uptake
Restricted availability under an FDA-mandated drug safety program has limited the reach of CAR-T cell therapies for certain blood cancers—until now. | The FDA has removed the REMS requirements for ...
FDA approves label updates for BMS’ CAR T cell therapies
Bristol Myers Squibb (BMS) has announced that the US Food and Drug Administration (FDA) has given approval to label updates ...
Targeted Oncology2h
FDA Approves Updated Labels on 2 CAR T-Cell Therapies
FDA updates CAR T-cell therapy labels for liso-cel and ide-cel, easing monitoring requirements and expanding access for ...
Bristol Myers wins favorable FDA label updates for cell therapies Breyanzi and Abecma
Bristol Myers (BMY) receives FDA approval for label updates for Breyanzi and Abecma, that can ease access to the cancer cell ...
Health Affairs4hOpinion
Congress Should Remove The Rare Disease Carve-Out From Medicare Drug Price Negotiation, Not Expand It
Expansion of the Medicare drug price negotiation rare disease drug carve-out would unnecessarily limit the number of drugs ...
Contract Pharma4h
FDA Approves REMS Programs in BMS Cell Therapy Labels
Bristol Myers Squibb (BMS) received U.S. Food and Drug Administration (FDA) approval for label updates for its CAR T cell ...
Fierce Biotech4h
Incyte, FDA, Sun Pharma and more—Chutes & Ladders
Incyte’s Hervé Hoppenot is hanging up his hat after spending more than a decade building the company into the multibillion-dollar commercial drugmaker it is today. Taking his place at the helm is Bill ...
2 Beaten-Down Stocks to Avoid
Editas Medicine (NASDAQ: EDIT) and Sarepta Therapeutics (NASDAQ: SRPT), two biotech companies, have encountered severe ...