FDA approvals - September 2025
September’s FDA approvals signaled shifting rules in biopharma - faster launches, smarter formulations, and bold plays from rising innovators and the familiar giants.
From stealth to spotlight: with $70m Series A, ‘total allergic control’ is Excellergy's goal
Backed by $70 million in Series A funding, Excellergy emerges from stealth with a mission to lead a new era in immunology - targeting the full IgE pathway to redefine how allergic diseases are treated.
New CEO of Kindbody David Stern is in the business of building families
“Fifteen to twenty years ago, a woman under 35 had a 20% chance of live birth per IVF cycle. At Kindbody, today, it’s greater than 50%,” David Stern credits lab innovation and AI for rewriting fertility’s odds.
A Legend in the making: how Ying Huang is scaling CAR-T to global markets
“After just one single infusion, about a third of patients remained in remission for five years. Some physicians even called it a functional cure,” Ying Huang underlines why CARVYKTI is reshaping expectations in oncology.
Breaking the bottleneck: why Oklo’s bet on Atomic Alchemy could change cancer care
"Some companies can’t even finish clinical trials because they can’t get enough material. It all comes down to the supply chain,” Thomas Eiden underscores why secure isotope access is critical for next-generation cancer treatment.
A Bushel of Change: Digitizing the Grain Supply Chain
“Around 80 percent of payments in agriculture are still paper checks. We’re literally burning gasoline to move paper,” Jake Joraanstad calls out the analog inefficiencies undermining agriculture’s bottom line.
Engines, Excipients, and Everyday Essentials: Elizabeth Grove on Lubrizol’s Sustainability Role
"Reducing our own footprint matters greatly, but the biggest point of impact is what our products can do; how they enhance sustainability when our customers use them; or when consumers use the products that our ingredients go into.”
One Trash Can, Infinite Possibilities: The Future of Recycling According to AMP
"I can tell Starbucks the exact number of their containers that came through - down to whether they came from a resident or a commercial business,” Tim Stuart shows how AMP’s AI turns data on trash into corporate sustainability insights.
Why Every Gigafactory Needs a Recycling Plant Next Door
"Nickel stays nickel, lithium stays lithium. If you recycle down to the elemental level, you can build them back up again and again - indefinitely,” Ryan Melsert reveals why elemental recovery is the foundation for a resilient battery supply chain.
ThredUp: Scaling Second-Hand for a Sustainable Future
"Second-hand in the U.S., and globally, is projected to nearly double by 2030. The short answer is that the world needs more resale,” ThredUp's James Reinhart reveals how partnerships, tech, and trust are fueling the recommerce boom.
From Strengthening Fleets to Smart Ships: Navigating Tanker Cycles with Ardmore
"Anybody can be a shipowner if they can raise the capital. What sets you apart is the organization you build around the ships,” Gernot Ruppelt highlights why culture and execution matter as much as fleet size in today’s tanker trade.
PowerTrack and Stem, Inc.’s Push for Renewable Confidence
"The CEO’s role isn’t operational - it’s to set the long-term vision and take the risk buffer so others can take the micro bets that are needed to help grow the business,” Arun Narayanan explains why long-term thinking is essential to scaling sustainable energy.
Capital With Conviction: How Khosla Ventures Walks With Founders for 10x Impact
"We’re hunting for the twelve entrepreneurs that will save the world - the 12 instigators,” Khosla Ventures' Rajesh Swaminathan highlights the firm’s disciplined focus on breakthrough founders and bold science.
How AI, Carbon Markets, and Co-Ops Are Changing the Economics of Farming
"Changing the mindset from ‘more fertilizer equals more grain’ to ‘resilient soils equals profitability’ takes proof,” Arva Intelligence's Jay McEntire underlines how farmers themselves are the real heroes of regenerative agriculture.
Feeding the Future: Inside Aurélio Pavinato’s Big Dream for Agriculture
"Our dream is to positively impact upon future generations, by being the leader in global efficiency in the agricultural sector, and, above all, to respect the planet,” Dr. Aurélio Pavinato outlines why soil health and circularity are central to SLC Agrícola's long-term growth.
From Pistons to Powertrains: The Road Ahead for Shriram Pistons & Rings
"Compressed natural gas requires a complete redesign of the pistons, the rings, and the engine valves - it’s not just a drop-in fuel,” Krishnakumar Srinivasan shows how SPR is future-proofing technology for CNG, ethanol, hybrids and EVs.