Biotech
The FDA Just Cleared a Fifth Eye Drop for Aging Eyes — and the First Four Barely Sold
The FDA approved Opus Genetics' RYZUMVI eye drop for presbyopia on Oct 16, 2026 — the fifth such drop, in a market where the first four barely sold.
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FDA
The latest FDA news and analysis from Tech Arcade.
Biotech
Teva's Monthly Schizophrenia Shot Skips the Three-Hour Waiting Room
Teva's WELTRUZA, the first once-monthly subcutaneous olanzapine shot, won FDA approval with zero post-injection syndrome cases in trials.
Biotech
The First Treatment for "Childhood Alzheimer's" Is One Shot — and a $3.95 Million Bill
The FDA just approved FAYUVI, the first-ever treatment for Sanfilippo syndrome type A: a one-time gene therapy from Ultragenyx priced at $3.95 million per patient.
Biotech
The First Sanfilippo Drug Ever Just Landed — at $3.95 Million a Dose
Ultragenyx's Fayuvi is the first-ever treatment for Sanfilippo syndrome type A — a one-time gene therapy priced at $3.95 million.
Biotech
A Once-Daily Pill Nearly Doubled Pancreatic Cancer Survival. Wall Street Shrugged.
Revolution Medicines' RASONQUE is the first broad RAS-targeted pill for metastatic pancreatic cancer, nearly doubling median survival to 13.2 months. The catch: $39,800 a month.
Biotech
Takeda Cracked Orexin. Its First-in-Class Narcolepsy Pill Could Do $2 Billion.
Takeda's Orzeyful is the first-in-class orexin agonist cleared to treat narcolepsy type 1 at its root cause — and Jefferies pegs peak sales near $2 billion.
Biotech
Ultragenyx Won Its First Gene Therapy Approval — and the Headline Number Is 31% Less Cornstarch
The FDA approved GENGLYCOS, Ultragenyx's first gene therapy and the first treatment for the root cause of glycogen storage disease type Ia. The headline result: 31% less daily cornstarch.
Biotech
Bristol Myers Just Launched a Whole New Class of Myeloma Drug — and Priced It at $29,500 a Cycle
Bristol Myers Squibb's Zenbexus is the first CELMoD approved for multiple myeloma — cleared on a doubled deep-remission rate (41% vs 21%) and priced at $29,500 a cycle.
Biotech
Rejected Twice, Approved on the Third Try: The Tumor-Injected Virus That Just Cleared the FDA
After two rejections, Replimune's tumor-injected virus Tudriqev won accelerated FDA approval on August 6 — a 24.2% response rate in melanoma that had beaten standard immunotherapy.
Biotech
A $425,000 Kidney Drug Just Cleared the FDA — and It Hits Two Targets No One Had Hit at Once
Vera Therapeutics just won FDA accelerated approval for TRUTAKNA, the first dual BAFF/APRIL inhibitor for IgA nephropathy — priced at $425,000 a year. Here's why the two-target bet matters.