FDA approval of Seres Therapeutics’ Vowst makes it the first oral microbiome therapy.

Source: https://medcitynews.com/2023/04/seress-bacteria-in-a-pill-becomes-first-fda-approved-oral-microbiome-therapy/

For example, the most recent anti-Alzheimer’s drug to win FDA approval is lecanemab.

Source: https://www.forbes.com/sites/howardgleckman/2023/05/17/the-war-over-whether-medicare-should-pay-for-the-new-anti-alzheimers-drugs/

In May, the company won FDA approval for Qalsody, a drug that treats amyotrophic lateral sclerosis patients whose disease is characterized by a particular genetic mutation.

Source: https://medcitynews.com/2023/07/biogen-acquisition-rare-disease-neuromuscular-reata/

In summary, the company continues to be well resourced to execute effective SER-109 commercialization activities pending FDA approval and to drive our ongoing development and preclinical programs.

Source: https://seekingalpha.com/article/4585321-seres-therapeutics-inc-mcrb-q4-2022-earnings-call-transcript?source=feed_all_articles

It has two approved drugs on the market and two others that it plans to submit for FDA approval this year.

Source: https://investorplace.com/2023/03/the-3-best-biotech-growth-stocks-to-buy/

Sachin was the first plastic surgeon in New York to inject the injectable treatment Kybella following its FDA approval.

Source: https://www.dailymail.co.uk/tvshowbiz/article-12656143/Alex-Pike-stuns-elegant-bridal-gown-confirming-new-romance-Manhattan-based-plastic-surgeon-Dr-Sachin-Shridharani-Counting-wedding-day.html?ns_mchannel=rss&ns_campaign=1490&ito=1490

So overall, if you think about the Opdualag program, the first indication, yes, we have that covered from an FDA approval perspective.

Source: https://seekingalpha.com/article/4585325-bristol-myers-squibb-company-bmy-presents-cowen-43rd-annual-healthcare-conference-transcript?source=feed_all_articles

“The FDA approval of Ezra Flash, which leverages AI to clear up rapid scans, is an important first step, since time is money in medical imaging.”

Source: https://1010wcsi.com/fox-health/ai-technology-catches-cancer-before-symptoms-with-ezra-a-full-body-mri-scanner/?utm_source=rss&utm_medium=rss&utm_campaign=ai-technology-catches-cancer-before-symptoms-with-ezra-a-full-body-mri-scanner

The good news is that as an established drug company, Pfizer has many clinical trials ongoing, particularly the important needed for FDA approval.

Source: https://investorplace.com/2023/03/3-vaccine-stocks-to-watch-for-their-post-pandemic-moves/

The US FDA approval represents “transition from a development-stage organisation to a commercial firm,” Dr Behrehbruch said, following news of the achievement.

Source: https://thenewdaily.com.au/finance/the-innovators/2023/03/27/innovators-australian-biomedical-companies/

The U.S. government became the biggest buyer and distributor of the drug after it received its emergency use authorizationPaxlovid’s FDA approval this past May put the product on track to transition to commercial sales channels.

Source: https://medcitynews.com/2023/10/pfizer-shaves-revenue-projections-starts-cost-cutting-plan-amid-lower-covid-19-product-demand/

While Novo Nordisk has yet to release the full trial details, the company’s plan to seek FDA approval for Wegovy’s cardiovascular benefits signals a significant advancement in obesity treatment.

Source: https://thefrontierpost.com/novo-nordisks-wegovy-obesity-drug-reduces-heart-attack-and-stroke-risk-by-20/

While the drug still has to undergo clinical trials, Loyal for Dogs hopes to gain full FDA approval by 2026.

Source: https://www.breitbart.com/health/2023/11/29/experimental-drug-aimed-extending-dogs-lifespans-clears-key-fda-regulatory-hurdle/