News & Analysis as of

Food and Drug Administration (FDA) Investors

Davis Wright Tremaine LLP

Food Venture Financing News – Weekly Issue No. 246

Food Venture Financing Trends - Bengaluru-based functional food startup Lo! Foods raised $3.5 million in a Series B funding round to enhance operational capabilities and launch new product lines....more

Cozen O'Connor

FDA Transparency Push: CRLs Released

Cozen O'Connor on

On July 10, 2025, citing a drive to increase transparency, the Food and Drug Administration (“FDA”) published more than 200 complete response letters (CRLs) previously issued to companies that had submitted new drug...more

Offit Kurman

Patents and the FDA: Four Critical Considerations Medical Device Companies Must Know to Successfully Introduce New Products into...

Offit Kurman on

The intersection of patent strategy and FDA regulatory strategy is a critical consideration for medical device companies. A well-integrated approach can create powerful barriers to entry, strengthen intellectual property (IP)...more

King & Spalding

FDA Publishes More Than 200 Complete Response Letters (CRLs) With More to Come

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On July 10, 2025, the Food and Drug Administration (FDA) announced that it had published more than 200 complete response letters (CRLs), in response to applications submitted to the FDA for approval of drugs or biological...more

Akin Gump Strauss Hauer & Feld LLP

FDA Opens the Vault on Decision Letters—Releases Wave of Drug and Biologic CRLs

This morning, the U.S. Food and Drug Administration (FDA) announced the publication of more than 200 decision letters, also known as complete response letters (CRLs), with plans to release more from the archives. The CRLs...more

Hogan Lovells

FDA’s creation of public database of 200 Complete Response letters raises questions

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The U.S. Food and Drug Administration (FDA) today published more than 200 complete response letters (CRLs) issued between 2002 and 2024. FDA reports that it has only published CRLs sent to companies whose drug and biological...more

Wilson Sonsini Goodrich & Rosati

[Event] 32nd Annual Medical Device & Digital Health Conference - June 5th - 6th, San Francisco, CA

Join medical device and digital health entrepreneurs, CEOs of venture-backed companies, and business development executives from large Medtech and digital health companies, as well as angels, venture capitalists, and...more

Morgan Lewis - As Prescribed

Navigating Key Challenges in M&A Deals in the Rare Disease Sector

In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan, focusing on issues impacting the rare disease community. The value of merger and...more

Akin Gump Strauss Hauer & Feld LLP

2025 Perspectives in Private Equity: Health Care & Life Sciences

Private equity investors in health care and life sciences must navigate a complex and shifting landscape influenced by regulatory and policy changes and technological advancements. As private equity investments in the health...more

Knobbe Martens

Heading Towards an Optimistic Initial Public Offerings (IPOs) Resurgence in 2025?

Knobbe Martens on

On January 16th, 2025, GT Medical Technologies, announced that it has raised $37 million in Series D financing round. The financing round was led by Evidity Health Capital and joined by Accelmed Partners. Current investors...more

Hogan Lovells

JPM panelists see opportunities under new U.S. regulators for venture capital and investing in emerging life sciences fields

Hogan Lovells on

The outcome of the 2024 U.S. election had far-reaching implications for the global investment landscape, especially in the dynamic field of venture capital and early-stage investing. Speaking at the J.P. Morgan Healthcare...more

Ropes & Gray LLP

U.S. Private Equity Market Recap - January 2025

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U.S. PE deal activity: Deal activity was slightly down in 2024 with a 3% YoY decline, while deal value was up 14%. Transaction activity did not make the strong comeback dealmakers were hoping for in 2024 as investors...more

Bradley Arant Boult Cummings LLP

How Will the Cannabis World Look When Marijuana Is Rescheduled?

A few weeks ago, someone at a holiday party asked “Whitt, why doesn’t Budding Trends take on the weighty legal issues of the day and instead resort to cheap pop culture references and puns?” I thought about responding with a...more

Cooley LLP

SEC charges Becton Dickinson with misleading investors about regulatory risks and product sales

Cooley LLP on

The SEC has announced settled charges against Becton, Dickinson and Company, a medical device manufacturer known as BD listed on the NYSE, for “repeatedly misleading investors about risks associated with its continued sales...more

ArentFox Schiff

Investigations Newsletter: Florida Telemarketer Sentenced to 15 Years in Prison for $67 Million Medicare Fraud Scheme

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Florida Telemarketer Sentenced to 15 Years in Prison for $67 Million Medicare Fraud Scheme - On December 6, Jose Goyos was sentenced to 15 years in prison for his role in managing a deceptive telemarketing scheme to...more

Wilson Sonsini Goodrich & Rosati

[Event] Biotech Summit 2024 - October 9th - 10th, Boston, MA

Wilson Sonsini’s inaugural Biotech Summit will address topics of critical importance to Biotech and Biopharmaceutical companies, including early and late-stage venture financing, partnering strategies, current and future AI...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 202: Life Sciences Startups and Industry Developments...

Maynard Nexsen on

Heather and Matthew welcome Dr. Gil Price, who has had an impressive career in the life sciences industry as a recently retired executive and currently serves as a board member for numerous companies. As an experienced leader...more

Greenbaum, Rowe, Smith & Davis LLP

Will Rescheduling Cannabis Open the Industry to Increased Financing, Real Estate and Banking Opportunities?

On May 16, 2024, the U.S. Department of Justice (DOJ) issued its proposed rules to transfer cannabis from Schedule I of the Controlled Substances Act (CSA) to Schedule III of the CSA. The DOJ’s proposal follows the U.S....more

ArentFox Schiff

Four Months Out: Private Fund Advisors Prepare for September Compliance Deadline Amidst Challenge in the Fifth Circuit

ArentFox Schiff on

In September 2023, we covered the Rules (Rule) published by the US Securities and Exchange Commission (SEC), developed to promote transparency for investors by increasing visibility into compensation schemes, sales practices,...more

Wilson Sonsini Goodrich & Rosati

[Event] Medical Device Digital Health Conference - June 13th - 14th, San Francisco, CA

Wilson Sonsini’s 31st Annual Medical Device & Digital Health Conference will address topics of critical importance to medical device and digital health companies, including early and late-stage venture financing, partnering...more

American Conference Institute (ACI)

[Event] 15th Summit on Biosimilars & Innovator Biologics - June 20th - 21st, New York, NY

Hosted by American Conference Institute, the Summit on Biosimilars & Innovator Biologics returns to New York City, on June 20 - 21, 2024. Now in its 15th year, the 2024 conference will dive deep into the latest legal,...more

Mintz

Client Corner: Meet CEO and COO of Suono Bio, Scott Kellogg & Skip Farinha

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Mintz’s Client Corner: Perspectives from Founders, Financiers, and Friends podcast series hosted by Mintz Member Joshua Fox explores the challenges and rewards associated with starting and running a business and investing in...more

Benesch

Dental/DSO Intelligence Monthly Report: February 2024

Benesch on

Conceived and founded by 16 doctors, EPIC4 is a unique entity—a Specialty Partnership Organization where dental specialists can maximize potential at all stages of their life and practice. Forming EPIC4 was something of an...more

Cooley LLP

Second Circuit Highlights Difficulty in Pleading Fraud Claims Involving the Interpretation of Clinical Data

Cooley LLP on

Plaintiffs often file securities fraud claims against pharmaceutical companies alleging that the company misled investors about clinical data, despite the US Food and Drug Administration (FDA) subsequently approving the drug...more

American Conference Institute (ACI)

[Event] 6th Annual Summit on Life Sciences IP Due Diligence - November 28th - 29th, Boston, MA

ACI’s 6th Annual Life Sciences IP Due Diligence Summit is devoted to providing corporate and IP counsel with expert strategies for assessing, valuing, and commercializing IP assets when conducting strategic IP due diligence –...more

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