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Investors › Prescription Drugs › Food and Drug Administration (FDA)

Cozen O'Connor

FDA Transparency Push: CRLs Released

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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

Akin Gump Strauss Hauer & Feld LLP

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

Akin Gump Strauss Hauer & Feld LLP on

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

Hogan Lovells on

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

Akin Gump Strauss Hauer & Feld LLP

2025 Perspectives in Private Equity: Health Care & Life Sciences

Akin Gump Strauss Hauer & Feld LLP on

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

Wilson Sonsini Goodrich & Rosati

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

Wilson Sonsini Goodrich & Rosati on

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

American Conference Institute (ACI)

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

American Conference Institute (ACI) on

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

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - April 2016

Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's (AGG) Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s...more

Sullivan & Worcester

Be Careful What You Say – Or Rather What You Don’t Say – AVEO Pays $4 Million to SEC to Settle Fraud Charges

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In March 2016, the Securities and Exchange Commission announced that AVEO Pharmaceuticals, Inc., a Massachusetts-based biopharmaceutical company, agreed, without admitting or denying the allegations, to pay $4 million to...more

Katten Muchin Rosenman LLP

“Sophisticated Plaintiff” Found to Be Adequate Class Representative

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The US District Court for the Western District of Texas certified a class of common stock purchasers in an action against Pain Therapeutics, Inc. (PTI) and its directors. The plaintiff’s complaint, which alleges that PTI...more

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