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Welcome to the Mondaq Food, Drugs, Healthcare, Life Sciences homepage, here you will find thought leadership articles, podcasts, videos and webinars providing insights covering topics such as Food and Drugs Law, Healthcare, Life Sciences, Biotechnology and Nanotechnology.

Takeda And Innovent Biologics Enter Collaboration Agreement On IBI343 And IBI363 Cancer Drugs

Last week, Takeda announced that it has entered into a worldwide license and collaboration agreement (outside of Greater China) with Innovent Biologics for the development, manufacture, and commercialization...

Worldwide Healthcare

GP

Goodwin Procter LLP

Spotlight On Upcoming Oral Arguments – November 2025

The following arguments will be available live to the public, both in-person and through online audio streaming. Access information will be available by 9 AM ET each day...

United States IP

FH

Finnegan, Henderson, Farabow, Garrett & Dunner, LLP

Health Law Diagnosed: The Summer / Fall 2025 PBM Policy And Legislative Update (Podcast)

In the latest episode of Health Law Diagnosed, Of Counsel Bridgette Keller is joined by Associate David Gilboa for an overview of the Summer / Fall 2025 PBM Policy and Legislative Update...

United States Healthcare

M

Mintz

Complete Response Letters In Transition: Navigating FDA's Transparency Policy And Manufacturing-Related Actions, And How To Respond

When FDA determines that a drug or biologic application (i.e., an NDA, ANDA, or BLA) is not approvable, it sends a complete response letter (CRL) to the application sponsor to communicate that the review...

United States Healthcare

AP

Arnold & Porter

1972 Washington Redskins Led Sweep Of Anti-Drug Public Service Campaign

United States Healthcare

HP

Hyman, Phelps, & McNamara

Benesch's Dental/DSO Intelligence Monthly Report: October 2025

United States Healthcare

B

Benesch Friedlander Coplan & Aronoff LLP

The Tests They Are A-Changing: FDA Takes Action On Biosimilars

United States Healthcare

HP

Hyman, Phelps, & McNamara

Holland & Knight Health Dose: November 4, 2025

United States Healthcare

HK

Holland & Knight

European Bioeconomy Alliance Report Confirms Benefits Of Using First-Generation Biomass For Food, Fuels, And Chemicals In Europe

European Union Healthcare

BC

Bergeson & Campbell

FDA Proposes To Eliminate Comparative Clinical Efficiency Studies For Biosimilars

United States Healthcare

AP

Arnold & Porter

California's New Allergen-Disclosure Law: A Sign Of Things To Come?

United States Healthcare

HP

Hyman, Phelps, & McNamara

Onshoring Drug Manufacturing: Insights From FDA's PreCheck Initiative And Public Meeting

United States Healthcare

HP

Hyman, Phelps, & McNamara

You've Got Mail, And Twice The Time To Respond! Two Device Companies Find Themselves With 30 Business Days To Respond To FDA's Warning Letters

United States Healthcare

HP

Hyman, Phelps, & McNamara

Bring Out Your Meds! Bring Out Your Meds!

United States Healthcare

HP

Hyman, Phelps, & McNamara

Control, Creativity, Closure: The Mediation Advantage

United States Litigation

J

JAMS

From Conflict To Clarity: Why The ADR Experience Matters In Successful Resolution

United States Litigation

J

JAMS

One Size Doesn't Fit All: Customizing Dispute Resolution For Commercial Contracts

United States Litigation

J

JAMS

Back To School 2025: Title IX Updates And How ADR Can Help Universities Resolve Disputes (Podcast)

United States Litigation

J

JAMS

What Honeybees Have Taught Me About Dispute Resolution

United States Litigation

J

JAMS

Where Have All The Good Guidance Gone?

While this author needs no excuse to listen to Van Halen, one surprising source of inspiration came while reviewing the body of guidance documents issued by CDRH in the last year.

United States Healthcare

HP

Hyman, Phelps, & McNamara

Strengthening Postapproval Monitoring: FDA's Draft Guidance On Cell & Gene Therapy Products

FDA recently released a draft guidance, titled "Postapproval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products,"...

United States Healthcare

HP

Hyman, Phelps, & McNamara

Real Food, Healthy Kids – And It's Not An Act

Actually, it is. No sooner had FDA flagged its intent to maybe eventually hammer out a federal definition of ultra-processed foods than California leapfrogged ahead with the Real Food, Healthy Kids Act (a/k/a AB 1264).

United States Healthcare

HP

Hyman, Phelps, & McNamara

RRA, RIE And MRA: FDA's Evolving Inspection Toolkit Still Has Boundaries

As part of the review of a BLA, NDA, or ANDA, FDA assesses the manufacturing facilities named in the application to determine whether they can perform the proposed manufacturing operations...

United States Healthcare

HP

Hyman, Phelps, & McNamara

FDA Proposes To Remove Comparative Efficacy Studies To Accelerate Biosimilar Development

United States Healthcare

JD

Jones Day

The Profit Crunch: How US Policy Could Reshape Global Pharma Research And Development (R&D)

Worldwide Healthcare

AM

Alvarez & Marsal

Health Headlines: October 2025

United States Healthcare

GP

Goodwin Procter LLP

Current Opportunities And Challenges In RWE And Its Future With AI

United States Healthcare

HP

Hyman, Phelps, & McNamara

Senate Passes Revised Version Of The BIOSECURE Act

United States Healthcare

HP

Hyman, Phelps, & McNamara

RWE And AI: Hand In Hand In The Future Of Regulatory Decision Making

United States Healthcare

HP

Hyman, Phelps, & McNamara

Inaugural Class Of Commissioner's National Priority Voucher Recipients Announced

United States Healthcare

HP

Hyman, Phelps, & McNamara

Streamlining The Studies: New FDA Guidance Aims To Speed Up Biosimilar Development

United States IP

AV

Axinn Veltrop & Harkrider

Ready Or Not: HRSA's 340B Rebate Pilot Model Takes Off Despite Questions On Readiness And Authority

United States Healthcare

PL

Polsinelli LLP

Food Venture Financing News – Weekly Issue No. 259

United States Healthcare

DW

Davis Wright Tremaine

Inaugural Class Of Commissioner's National Priority Voucher Recipients Announced

We previously blogged about the Commissioner's National Priority Voucher (CNPV), FDA's new pilot program to expedite the reviews of selected...

United States Healthcare

HP

Hyman, Phelps, & McNamara

Streamlining The Studies: New FDA Guidance Aims To Speed Up Biosimilar Development

On Wednesday, the FDA issued a new draft guidance proposing to reduce the need for sponsors to conduct a comparative efficacy study (CES) to demonstrate biosimilarity...

United States IP

AV

Axinn Veltrop & Harkrider

Ready Or Not: HRSA's 340B Rebate Pilot Model Takes Off Despite Questions On Readiness And Authority

On October 30, 2025 despite HRSA being impacted by the government shutdown, the agency approved 8 drug manufacturers / 9 drugs for participation in HRSA's 340B Rebate Model Pilot Program (340B Rebate Pilot).

United States Healthcare

PL

Polsinelli LLP

Food Venture Financing News – Weekly Issue No. 259

Agtonomy, a California-based ag robotics company, closed an $18 million Series B round.

United States Healthcare

DW

Davis Wright Tremaine

FDA Grants Interchangeability Designation To Fresenius Kabi's And Celltrion's Denosumab Biosimilars

United States Healthcare

GP

Goodwin Procter LLP

Senate HELP Committee Hearing Spotlights The 340B Program's Growth And Impact On Patients

On October 23, the Senate Committee on Health, Education, Labor, and Pensions (HELP) held a hearing on the 340B program...

United States Healthcare

MP

Manatt, Phelps & Phillips LLP

Teva And Prestige Biopharma Enter Licensing Agreement To Commercialize Their Trastuzumab Biosimilar

On October 20, 2025, Teva Pharmaceuticals International GmbH ("Teva") announced a licensing agreement with Prestige BioPharma Ltd. ("Prestige BioPharma") to commercialize TUZNUE® (trastuzumab), a biosimilar to Genentech's HERCEPTIN (trastuzumab), in a majority of European countries.

United States Healthcare

GP

Goodwin Procter LLP

FDA Approves Genentech's GAZYVA® (Obinutuzumab)

On October 20, 2025, the FDA approved Genentech's GAZYVA® (obinutuzumab) as a treatment for adults with lupus nephritis (LN).

United States Healthcare

GP

Goodwin Procter LLP

MAHA Is Coming For Ultra-Processed Foods And Other Food Reforms; Red And Some Blue States Are Answering

The Make America Healthy Again (MAHA) movement is reshaping state and federal regulatory priorities.

United States Media & IT

KD

Kelley Drye & Warren LLP

Manatt Health: Health AI Policy Tracker Q3 Update

United States Healthcare

MP

Manatt, Phelps & Phillips LLP

California SB 41: Pharmacy Benefit Managers Now Held To Fiduciary And Transparency Standards

United States Employment

DW

Davis Wright Tremaine

CRLs Unveiled: Converting FDA Transparency Into A Market Advantage

United States Healthcare

AM

Alvarez & Marsal

U.S. Sanctions Colombia's President Under Global Illicit Drug Trade Program

United States International

HK

Holland & Knight

New Drug Approvals: "Human Organ-on-a-Chip" GAO Report Supports Innovation And Regulatory Policy For Non-Animal Models

United States Healthcare

FL

Foley & Lardner

Holland & Knight Health Dose: October 28, 2025

United States Healthcare

HK

Holland & Knight

Illinois To Require Illinois-Licensed PICs For Nonresident Pharmacies Effective January 1, 2026

United States Healthcare

BI

Buchanan Ingersoll & Rooney PC

Open Season Nears: Advanced Premium Tax Credits And Potential Paths Forward

United States Healthcare

HK

Holland & Knight

FDA Presses Forward On Patient-Focused Drug Development, Releases Final Guidance Focused On Fit-For-Purpose Clinical Outcome Assessments

United States Healthcare

AG

Akin Gump Strauss Hauer & Feld LLP

This Week From The Hill (October 26 – November 1, 2025)

United States Employment

GL

Groom Law Group

Trump Administration Targets PBM Reform To Lower Drug Prices

United States Healthcare

HB

Hall Benefits Law

AI In Health Care And Biotechnology: Promise, Progress, And Challenges

United States Healthcare

FL

Foley & Lardner

California's Governor Newsom Announces That State Sponsored Insulin Pen Will Be Available Jan 1, 2026

United States Healthcare

GP

Goodwin Procter LLP

Recent Rulings Highlight Risk To Japanese Drugmakers In Settling Pharmaceutical Litigations

United States Healthcare

JB

Jenner & Block

The Alabama Board Of Pharmacy: What Licensees Need To Know About Rule 680-X-2-.40 Ahead Of The November 19 Hearing/Meeting

United States Healthcare

BI

Buchanan Ingersoll & Rooney PC

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Highlighted Content

The Nexus Of Trade And Food Security Amid Global Conflicts

United States International

BG

Braumiller Law Group, PLLC

Any Comments On FDA's New Proposed Rule On Prior Notice Regulations?

United States International

BG

Braumiller Law Group, PLLC

World Trade And Invasion, One Year Later – Are We On The Brink Of A New World Order?

United States International

BG

Braumiller Law Group, PLLC

Infringement Of Repurposed Drug Patents And Skinny Labelling – Where Does The Balance Lie In The United States Today?

United States Healthcare

D

Dehns

Infringement Of Repurposed Drug Patents And Skinny Labelling – Where Does The Balance Lie In Europe Today?

United States Healthcare

D

Dehns

Latest Videos

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The Exploration Crisis: Why Oil & Gas Companies Are Finding Less While Demand Keeps Growing (Video)

AM

Alvarez & Marsal

Non-binding Guidance: The Administration's Focus On Direct-to-Consumer Prescription Drug Advertising (Podcast)

RG

Ropes & Gray LLP

Critical Medical Device Series: Part VI Navigating Innovation: The FDA's Role In Regulating Medical Technology (Video)

AP

Arnold & Porter

Live From Workplace Horizons 2025: What's Hot In ERISA — Forfeiture And Tobacco Surcharge Class Actions (Video)

JL

Jackson Lewis P.C.

Concerns For Employers Surrounding Employee Drug And Alcohol Testing Policies (Video)

FS

Foster Swift Collins & Smith

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