• Home
  • Latest
  • Fortune 500
  • Finance
  • Tech
  • Leadership
  • Lifestyle
  • Rankings
  • Multimedia
NewslettersBrainstorm Health

The FDA Went on an Epic Drug Approval Binge This Week: Brainstorm Health

By
Sy Mukherjee
Sy Mukherjee
Down Arrow Button Icon
By
Sy Mukherjee
Sy Mukherjee
Down Arrow Button Icon
August 16, 2019, 5:30 PM ET

Happy Friday, readers!

The Food and Drug Administration (FDA) isn’t resting on its laurels in the dog days of summer.

In the past week, the FDA has approved five novel new drugs to treat a slew of conditions from cancer to the skin disease psoriasis to tuberculosis (TB) to the sleep disorder narcolepsy. Two of the approvals were granted Wednesday; another one on Thursday; and then two more on Friday.

Here’s what they were, in chronological order: Pretomanid, a medicine for the most drug-resistant forms of TB that was created by the nonprofit TB Alliance and will be distributed by Mylan; Wakix, a new therapy from private firm Harmony Biosciences to treat excessive daytime sleepiness in narcolepsy patients (and reportedly the first drug of its kind to not be classified as a controlled substance by the DEA); Roche’s Rozlytrek, a personalized cancer treatment that is specific to genetics rather than a specific kind of tumor or cancer; Celgene’s Inrebic, a so-called “JAK inhibitor” approved for the bone marrow cancer myelofibrosis (and whose green light is a boon to drug giant Bristol-Myers Squibb, which is buying Celgene); and, finally, Rinvoq, a rheumatoid arthritis drug from biotech giant AbbVie which the company hopes will staunch bleeding sales of its nearly two-decade-old superstar Humira, which is still the world’s best-selling drug. AbbVie is currently in the process of buying Botox maker Allergan in its own mega-deal.

It should be noted that the latter two treatments from Celgene and AbbVie are part of a class that come with some notable adverse events and black box warnings. Still, they could prove an improvement to certain patients.

All told, the FDA has now approved 23 new treatments to date this year. And this is now a multi-year trend with the agency, which appears eager to get as many new treatments (branded, generic, or otherwise) onto the market as soon as possible. (How efficacious and cost-effective those treatments are, of course, is a more complicated discussion.)

Read on for the day’s news, and have a wonderful weekend.

Sy Mukherjee, @the_sy_guy, sayak.mukherjee@fortune.com

DIGITAL HEALTH

Gates Foundation picks up an Apple digital health vet. The Bill & Melinda Gates Foundation has snatched up Dr. Andrew Trister, a veteran of Apple's burgeoning digital health department, in order to help fund digital health startups and ventures aiming for a global impact. The Foundation has consistently shown an interest in using technology to mitigate community health issues in isolated and troubled regions. (pharmaphorum)

INDICATIONS

The company formerly known as Valeant is still hiking prices. "Valeant Pharmaceuticals" is now technically known as "Bausch Healthcare." But it appears that some habits die hard. A Wells Fargo analyst, in a new research note, writes that Bausch is still relying on price hikes to plug holes in its revenue stream and make up for a lackluster pipeline. Valeant became a punching bag for presidential candidates in the 2016 election. (FiercePharma)

THE BIG PICTURE

Obamacare replacement is a flat circle. Ok, I'm sorry for the now-dated pop culture reference. But here we are again. The Trump administration says that it's actively working on a new Obamacare replacement plan should courts strike down the entirety of the law as part of a suit being supported by the administration (and also, apparently, just in general since Congressional Republicans have failed to coalesce around any specific Affordable Care Act alternative for nearly 10 years). Like many previous efforts along these lines, there isn't a set timeline for when the plan will be released, and ACA repeal at the Congressional level is D.O.A anyways with the House being controlled by Democrats. (The Hill)

REQUIRED READING

Google's Hate Speech Detection A.I. Has a Racial Bias Problem, by Jonathan Vanian

Commentary: Regulate Fintechs for What They Do, Not What They Don't, by Kathryn Petralia

Plunge in 30-Year Treasury Bonds Spells the End of America's Golden Age, to Some, by Erik Sherman

The Weirdness of WeWork's IPO Filing, by Alan Murray

Find past coverage. Sign up for other Fortune newsletters.

About the Author
By Sy Mukherjee
See full bioRight Arrow Button Icon

Latest in Newsletters

Finance
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam
By Fortune Editors
October 20, 2025
Finance
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam
By Fortune Editors
October 20, 2025
Finance
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam
By Fortune Editors
October 20, 2025
Finance
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam
By Fortune Editors
October 20, 2025
Finance
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam
By Fortune Editors
October 20, 2025
Finance
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam
By Fortune Editors
October 20, 2025

Most Popular

Finance
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam
By Fortune Editors
October 20, 2025
Finance
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam
By Fortune Editors
October 20, 2025
Finance
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam
By Fortune Editors
October 20, 2025
Finance
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam
By Fortune Editors
October 20, 2025
Finance
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam
By Fortune Editors
October 20, 2025
Finance
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam
By Fortune Editors
October 20, 2025
Fortune Secondary Logo
Rankings
  • 100 Best Companies
  • Fortune 500
  • Global 500
  • Fortune 500 Europe
  • Most Powerful Women
  • World's Most Admired Companies
  • See All Rankings
  • Lists Calendar
Sections
  • Finance
  • Fortune Crypto
  • Features
  • Leadership
  • Health
  • Commentary
  • Success
  • Retail
  • Mpw
  • Tech
  • Lifestyle
  • CEO Initiative
  • Asia
  • Politics
  • Conferences
  • Europe
  • Newsletters
  • Personal Finance
  • Environment
  • Magazine
  • Education
Customer Support
  • Frequently Asked Questions
  • Customer Service Portal
  • Privacy Policy
  • Terms Of Use
  • Single Issues For Purchase
  • International Print
Commercial Services
  • Advertising
  • Fortune Brand Studio
  • Fortune Analytics
  • Fortune Conferences
  • Business Development
  • Group Subscriptions
About Us
  • About Us
  • Press Center
  • Work At Fortune
  • Terms And Conditions
  • Site Map
  • About Us
  • Press Center
  • Work At Fortune
  • Terms And Conditions
  • Site Map
  • Facebook icon
  • Twitter icon
  • LinkedIn icon
  • Instagram icon
  • Pinterest icon

Latest in Newsletters

Aerie built a brand based on ‘real.’ That’s at the heart of its ‘no AI’ promise
NewslettersMPW Daily
Aerie built a brand based on ‘real.’ That’s at the heart of its ‘no AI’ promise
By Emma HinchliffeMay 1, 2026
11 hours ago
The fruit fly cancer researcher who built his first prototype out of lollipop sticks and straws
NewslettersTerm Sheet
The fruit fly cancer researcher who built his first prototype out of lollipop sticks and straws
By Allie GarfinkleMay 1, 2026
17 hours ago
Apple CEO Tim Cook in Washington, D.C. on December 10, 2025. (Tom Williams/CQ-Roll Call/Getty Images)
NewslettersFortune Tech
Tim Cook’s advice for Apple’s next CEO
By Andrew NuscaMay 1, 2026
17 hours ago
Brian Niccol’s nascent Starbucks turnaround starts with treating workers better
NewslettersCEO Daily
Brian Niccol’s nascent Starbucks turnaround starts with treating workers better
By Phil WahbaMay 1, 2026
18 hours ago
Meta's Hyperion data-center site in Northeastern Louisiana.
NewslettersEye on AI
Big Tech will spend nearly $700 billion on AI this year. No one knows where the buildout ends
By Sharon GoldmanApril 30, 2026
1 day ago
The Tory Burch Foundation is almost halfway to its $1 billion goal for women entrepreneurs
NewslettersMPW Daily
The Tory Burch Foundation is almost halfway to its $1 billion goal for women entrepreneurs
By Emma HinchliffeApril 30, 2026
1 day ago

Most Popular

Scott Bessent on financial literacy: 'it drives me crazy' to see young men in blue-collar construction jobs playing the lottery
Personal Finance
Scott Bessent on financial literacy: 'it drives me crazy' to see young men in blue-collar construction jobs playing the lottery
By Fatima Hussein and The Associated PressMay 1, 2026
15 hours ago
China dominates the world's lithium supply. The U.S. just found 328 years' worth in its own backyard
North America
China dominates the world's lithium supply. The U.S. just found 328 years' worth in its own backyard
By Jake AngeloApril 30, 2026
1 day ago
The U.S. economy is booming — just not where 50 million Americans live
Commentary
The U.S. economy is booming — just not where 50 million Americans live
By Derek KilmerMay 1, 2026
19 hours ago
Accenture's Julie Sweet blew up 50 years of company history. She says the hardest part is still ahead
Conferences
Accenture's Julie Sweet blew up 50 years of company history. She says the hardest part is still ahead
By Nick LichtenbergApril 29, 2026
3 days ago
Apple cofounder Ronald Wayne—whose stake would be worth up to $400 billion had he not sold it in 1976—says that at 91, he has no regrets
Success
Apple cofounder Ronald Wayne—whose stake would be worth up to $400 billion had he not sold it in 1976—says that at 91, he has no regrets
By Preston ForeApril 27, 2026
5 days ago
Current price of oil as of May 1, 2026
Personal Finance
Current price of oil as of May 1, 2026
By Joseph HostetlerMay 1, 2026
15 hours ago

© 2026 Fortune Media IP Limited. All Rights Reserved. Use of this site constitutes acceptance of our Terms of Use and Privacy Policy | CA Notice at Collection and Privacy Notice | Do Not Sell/Share My Personal Information
FORTUNE is a trademark of Fortune Media IP Limited, registered in the U.S. and other countries. FORTUNE may receive compensation for some links to products and services on this website. Offers may be subject to change without notice.