FDA Webview
X
wifi-social twitter-social
search
latest-news
Human Drugs

FDA Unveils Plausible Mechanism Framework Guidance

FDA issues a draft guidance entitled Considerations for the Use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause.

Continue Reading
latest-news
Human Drugs

Calquence Combo OK’d for Leukemia, Lymphoma

FDA approves AstraZeneca’s Calquence (acalabrutinib) for use in combination with AbbVie and Genentech’s Venclexta (venetoclax), a chemotherapy-free regimen for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma.

Continue Reading
fda-generl-home
Human Drugs

Novo Nordisk Obesity Drug Misses Endpoint

fda-generl-home
Human Drugs

Calquence Combo OK’d for Leukemia, Lymphoma

fda-generl-home
Human Drugs

FDA Unveils Plausible Mechanism Framework Guidance

fda-generl-home
Human Drugs

CDER’s Hoeg has SSRIs, mAbs in Crosshairs

LATEST NEWS

View All
motusgi
FDA Unveils Plausible Mechanism Framework Guidance

FDA issues a draft guidance entitled Considerations for the Use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause.

motusgi
Calquence Combo OK’d for Leukemia, Lymphoma

FDA approves AstraZeneca’s Calquence (acalabrutinib) for use in combination with AbbVie and Genentech’s Venclexta (venetoclax), a chemotherapy-free regimen for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma.

motusgi
Novo Nordisk Obesity Drug Misses Endpoint

Novo Nordisk says its experimental obesity drug CagriSema delivered substantial weight loss in a head-to-head late-stage trial but failed to meet its primary objective of proving it was not inferior to Eli Lilly’s rival therapy tirzepatide (Zepbound and Mounjaro).

motusgi
Genentech NDA for Breast Cancer Therapy

FDA accepts for review a Genentech NDA for giredestrant for treating patients with endocrine-resistant breast cancer.

Categories

Top News

newsletter-first

FDA Webview Free Daily e-Newsletter

Free Sign-Up

Animal Drugs

View All
medical-devices
Read More
FDA Warns Elanco Animal Health About Pradalex Ads

The Center for Veterinary Medicine warns Elanco Animal Health about false and misleading claims in promotional materials for its Pradalex that treats ...

medical-devices
Read More
Antimicrobial Drug Duration of Use Guidance

FDA publishes a guidance with recommendations for how sponsors of animal drugs may facilitate changes to the approved conditions of use of specific ty...

medical-devices
Read More
Sangamo Begins Rolling BLA for Fabry Gene Therapy

Sangamo Therapeutics begins a rolling BLA submission seeking accelerated approval of its experimental Fabry disease gene therapy, following result...

medical-devices
Read More
Sydnexis Pediatric Myopia Drug Meets Endpoints

Sydnexis says its SYD-101 drug to treat pediatric progressive myopia met both the primary and key secondary endpoints in the Phase 3 STAR trial.

Biologics

View All
medical-devices
Read More
FDA Flip Flops; Agrees to Now Review Moderna Vaccine

FDA reverses course and agrees to review Moderna’s seasonal influenza mRNA vaccine after previously refusing to file the BLA.

medical-devices
Read More
Debate Intensifies Over Politicization of mRNA Vaccines

FDA’s refusal to review Moderna’s mRNA influenza vaccine reignites concerns that vaccine policy — particularly involving mRNA technology — is becoming...

medical-devices
Read More
Turmoil Mounts Under Prasad’s Leadership: WSJ

CBER faces mounting scrutiny after its top official, director Vinay Prasad, refused the review of Moderna’s flu vaccine application— a move that some ...

medical-devices
Read More
CBER Head Overruled Staff on Moderna Flu Vaccine Filing

CBER director Vinay Prasad overrules the Center’s career reviewers in deciding to issue Moderna a refusal-to-file letter for its BLA for an influenza ...

FDA General

View All
medical-devices
Read More
JAMA Examines FDA’s Move Away From Advisory Committees

A new JAMA Health Forum analysis examines FDA’s shift in how it seeks outside scientific advice while shunning advisory committee meetings, raising le...

medical-devices
Read More
Trust in FDA and CDC Remains Low After Vaccine Changes

A new poll finds public confidence in FDA and Centers for Disease Control and Prevention remains low following recent changes to the federally recomme...

medical-devices
Read More
FDA’s Expanding Role, Staff Cuts Challenge Oversight: GAO

A new GAO report finds FDA’s regulatory responsibilities expanded substantially between fiscal years 2008 and 2024, and now it faces workforce reducti...

medical-devices
Read More
Guide on Device Cybersecurity Released

FDA posts a final guidance entitled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.

newsletter-second

FDA Webview Free Daily e-Newsletter

Free Sign-Up

Federal Register

View All
motusgi
Read More
PDUFA Public Meeting for User Fee Reauthorization

Federal Register notice: FDA announces a 7/14 public meeting to discuss proposed recommendations for...

motusgi
Read More
Generic Drug Fee Program Reauthorization Meeting

Federal Register notice: FDA hosts a 7/11 public meeting on the reauthorization of the Generic Drug ...

motusgi
Read More
FDA Withdraws and Reissues 2 Guidances

FDA says it is withdrawing two recent final guidances on cell- and tissue-based products and reissui...

motusgi
Read More
CDER Continues Quality Management Program

Federal Register notice: FDA seeks drug manufacturing establishments to participate in the second ye...

Human Drugs

View All
motusgi
Read More
FDA Unveils Plausible Mechanism Framework Guidance

FDA issues a draft guidance entitled Considerations for the Use of the Plausible Mechanism Framework...

motusgi
Read More
Calquence Combo OK’d for Leukemia, Lymphoma

FDA approves AstraZeneca’s Calquence (acalabrutinib) for use in combination with AbbVie and Genentec...

motusgi
Read More
Novo Nordisk Obesity Drug Misses Endpoint

Novo Nordisk says its experimental obesity drug CagriSema delivered substantial weight loss in a hea...

motusgi
Read More
Genentech NDA for Breast Cancer Therapy

FDA accepts for review a Genentech NDA for giredestrant for treating patients with endocrine-resista...

Marketing

View All
motusgi
Read More
Neffy Broadcast Ad ‘False or Misleading’: OPDP

An FDA Untitled Letter cautions ARS Pharmaceutical about false or misleading claims for its Neffy na...

motusgi
Read More
Cobenfy Ad Letter Signals Tight Limits on DTC Claims: Attorneys

A December FDA violation letter targeting a schizophrenia drug advertisement from Bristol Myers Sq...

motusgi
Read More
FDA Flags AstraZeneca’s Farxiga TV Ad as Misleading

FDA cites a direct-to-consumer television advertisement for AstraZeneca’s Farxiga (dapagliflozin) ta...

motusgi
Read More
Oversight of Influencer Social Media Posts Hard: Researchers

University of Chicago researchers explain how difficult it will be to improve government oversight o...

Medical Devices

View All
motusgi
Read More
FDA Accepts Sibel Aria Cough Sensor in DDT

FDA accepts the Sibel Aria cough sensor into its Drug Development Tool qualification program.

motusgi
Read More
Petition Seeks Restrictions on Robotic Surgical Device

A patient safety group urges FDA to rescind or narrow a recent device clearance that allows use of a...

motusgi
Read More
Trividia True Metrix Glucose Monitor Early Alert

An FDA Early Alert says Trividia Health has issued updated use instructions for its True Metrix bloo...

motusgi
Read More
Medline Class 1 Recall on Malfunctioning Beds

Medline recalls (Class 1 device correction) certain Medline homecare beds as a Class I recall, warni...