Targeted Oncology

In a First, FDA Approves Monthly Subcutaneous Amivantamab for EGFR+ NSCLC

FDA approves monthly subcutaneous amivantamab plus lazertinib for EGFR-mutated advanced NSCLC, cutting clinic time and ...

Health Canada Approves Merck's Subcutaneous Version of Keytruda Cancer Drug

Canada's health regulator has approved Merck's new under-the-skin version of its cancer drug Keytruda, offering an alternative to the current intravenous infusion. Health Canada has approved Keytruda ...

Halozyme outlines $1.71B–$1.81B 2026 revenue target as new subcutaneous technologies expand pipeline

Current quarter guidance for 2026 total revenue of $1.71 billion to $1.81 billion and non-GAAP diluted EPS of $7.75 to $8.25 marks a substantial increase from the previous quarter's guidance of $1.3 ...
PharmExec

FDA Approves Monthly Dosing Schedule for Rybrevant Faspro

FDA approved a simplified, once-monthly dosing schedule for Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) when used in combination with Lazcluze (lazertinib) as a first-line treatment for ...

Halozyme Therapeutics (NASDAQ:HALO) Surprises With Q4 CY2025 Sales

Biopharmaceutical drug delivery company Halozyme Therapeutics (NASDAQ:HALO) reported revenue ahead of Wall Street’s ...

Long Term Data Published in JAMA Neurology Demonstrate Sustained Efficacy and Consistent Safety of BRIUMVI in Relapsing Multiple Sclerosis

During year 5 of treatment with BRIUMVI the annualized relapse rate was 0.020, equivalent to one relapse occurring every 50 years of patient ...

Crispr: Emphasis Shifts To Cardiovascular Pipeline Amid Slow Casgevy Launch

CRISPR Therapeutics stays a Hold as CASGEVY launch lags; watch cash burn, revenue delays, and CTX310/CTX611 catalysts for ...

Johnson & Johnson: FDA approves RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) as the only EGFR-targeted therapy that can be administered once a month

Monthly dosing reduces treatment visits while maintaining established safety and efficacy1,2 Builds on RYBREVANT FASPRO FDA approval to deliver the simplest and fastest ...
Le Lézard

ImmunityBio Reports Productive Regulatory Engagement with Saudi Food and Drug Authority at USA-Saudi Biotech Alliance Meeting Hosted by the Ministry of Investment of Saudi Arabia

ImmunityBio, Inc. , a commercial stage immunotherapy company developing next generation therapies that drive immunological memory and restore immune competence, today announced that the Company held ...

Halozyme (HALO) Q4 2025 Earnings Call Transcript

As I look back on the past year, it is clear that 2025 was one of the most significant and value-creating years in Halozyme Therapeutics, Inc.'s history. This level of execution has created a clear ...
The American Journal of Managed Care

FDA Approves Once-Monthly SC Amivantamab Dosing in EGFR-Mutated NSCLC

The FDA has approved a new, simplified monthly subcutaneous (SC) dosing schedule for amivantamab and hyaluronidase-lpuj (Rybrevant Faspro; Johnson & Johnson) for the treatment of patients with ...
Le Lézard

FDA approves RYBREVANT FASPROtm (amivantamab and hyaluronidase-lpuj) as the only EGFR-targeted therapy that can be administered once a month

Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved a new, simplified monthly dosing schedule* for RYBREVANT FASPROtm (amivantamab and hyaluronidase-lpuj). When ...