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PharmaRadar360

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Pharmaceutical industry news

Fresh coverage across pharma, biotech, medtech, research, approvals, and market-moving developments.

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🌍Regulatorypharmac.govt.nz

Wegovy and Mounjaro for weight loss not funded

Pharmac New ZealandOriginal source
🌍discoverynews.google.com

Shinhan Securities Cuts Alteogen Target to β‚©520,000 After Novartis AOC Phase 3 Failure

finance.biggo.comOriginal source
🌍Regulatoryacrpnet.org

Many Different Paths May Lead to a Role in Clinical Project Management

ACRP AssociationOriginal source
🌍discoverynews.google.com

[Click e-Stock] "One Novartis New Drug Fails Phase 3" Target Price for Alteogen Lowered

μ•„μ‹œμ•„κ²½μ œOriginal source
πŸ‡ΊπŸ‡ΈRegulatorysec.gov

Novo Nordisk filed Form 6-K

SEC EDGAROriginal source
πŸ‡ΊπŸ‡ΈRegulatorysec.gov

GSK filed Form 6-K

SEC EDGAROriginal source
🌍Researchnature.com

Commensal Nakaseomyces glabratus migrates into prostate tumors to accelerate cancer progression

Nature CancerOriginal source
πŸ‡¬πŸ‡§Researchnature.com

Barriers and facilitators to the implementation of pharmacogenomic testing for antidepressants use in primary care: a systematic review using the consolidated framework for implementation research

The Pharmacogenomics JournalOriginal source
πŸ‡¬πŸ‡§Researchnature.com

Upcoming FDA approval decisions in Q4 2026

Nature Reviews Drug DiscoveryOriginal source
πŸ‡¬πŸ‡§Researchnature.com

A translational framework for extrahepatic oligonucleotide delivery

Nature Reviews Drug DiscoveryOriginal source
πŸ‡ΊπŸ‡ΈRegulatoryfederalregister.gov

Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates; Guidance for Industry; Availability

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a guidance f...

Federal RegisterOriginal source
πŸ‡ΊπŸ‡ΈRegulatoryfederalregister.gov

Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-2027 Southern Hemisphere Influenza Virus Vaccines

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of...

Federal RegisterOriginal source
πŸ‡ΊπŸ‡ΈRegulatoryfederalregister.gov

Agency Information Collection Activities; Proposed Collection; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based Products

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on...

Federal RegisterOriginal source
πŸ‡ΊπŸ‡ΈRegulatoryfederalregister.gov

Privacy Act of 1974; System of Records

In accordance with the Privacy Act of 1974, as amended, the Department of Health and Human Services...

Federal RegisterOriginal source
πŸ‡ΊπŸ‡ΈRegulatoryfederalregister.gov

Determination of Regulatory Review Period for Purposes of Patent Extension; ANDEMBRY

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for...

Federal RegisterOriginal source
πŸ‡ΊπŸ‡ΈRegulatoryfederalregister.gov

Agency Information Collection Activities; Proposed Collection; Comment Request; Pregnancy Exposure Registry Enrollment Project: A Survey of Health Care Providers To Advance Pregnancy Safety Data Collection and Improve Health Communications

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on...

Federal RegisterOriginal source
πŸ‡ΊπŸ‡ΈRegulatoryfederalregister.gov

Determination of Regulatory Review Period for Purposes of Patent Extension; ANZUPGO

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for...

Federal RegisterOriginal source
πŸ‡ΊπŸ‡ΈRegulatoryfederalregister.gov

Determination of Regulatory Review Period for Purposes of Patent Extension; ANKTIVA

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for...

Federal RegisterOriginal source
πŸ‡ΊπŸ‡ΈRegulatoryfederalregister.gov

National Vaccine Injury Compensation Program; List of Petitions Received

HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation...

Federal RegisterOriginal source
πŸ‡ΊπŸ‡ΈRegulatoryfederalregister.gov

Reorganization of the National Center for Immunization and Respiratory Diseases

CDC has modified its structure. This notice announces the reorganization of the National Center for...

Federal RegisterOriginal source
πŸ‡ΊπŸ‡ΈRegulatoryopen.fda.gov

Drug label update: MUCINEX FAST-MAX Liquid Gels Day Night Cold and Flu

Official structured record identifier: 3856c1e4-814f-85c4-e063-6394a90ab8a8.

openFDA Drug LabelsOriginal source
πŸ‡ΊπŸ‡ΈRegulatoryopen.fda.gov

Drug label update: Donepezil

Official structured record identifier: 37fc6638-4a63-4582-a64c-3525f8ed7ef2.

openFDA Drug LabelsOriginal source
πŸ‡ΊπŸ‡ΈRegulatoryopen.fda.gov

Drug label update: Zinc Oxide

Official structured record identifier: 35e67726-4527-4cd7-8e73-30325a32402c.

openFDA Drug LabelsOriginal source
πŸ‡ΊπŸ‡ΈRegulatoryopen.fda.gov

Drug label update: Oxycodone Hydrochloride

Official structured record identifier: 338b5391-e5f7-40a2-8b15-57f47cbc4813.

openFDA Drug LabelsOriginal source
πŸ‡ΊπŸ‡ΈRegulatoryopen.fda.gov

Drug label update: Nighttime Sleep Aid Berry Flavor

Official structured record identifier: 303d7651-9c8f-4a14-9f2c-7181fa0f003e.

openFDA Drug LabelsOriginal source
πŸ‡ΊπŸ‡ΈRegulatoryopen.fda.gov

Drug label update: Head and Shoulders Bare Minimal Ingredients Pure Clean 2in1

Official structured record identifier: 2cc726c2-3747-6dbf-e063-6294a90a789f.

openFDA Drug LabelsOriginal source
πŸ‡ΊπŸ‡ΈRegulatoryopen.fda.gov

Drug label update: Mucus Relief Cold Flu and Sore Throat Maximum Strength

Official structured record identifier: 2cb3e17f-3858-4773-a53f-0860ae6ff1b9.

openFDA Drug LabelsOriginal source
πŸ‡ΊπŸ‡ΈRegulatoryopen.fda.gov

Drug label update: Scopolamine

Official structured record identifier: 2a6f9aaf-a70a-481f-a82b-1dcaaadc185b.

openFDA Drug LabelsOriginal source
πŸ‡ΊπŸ‡ΈRegulatoryopen.fda.gov

Drug label update: Pramipexole Dihydrochloride

Official structured record identifier: 29b639e3-25a5-4c2f-b4ea-a119db79fe0c.

openFDA Drug LabelsOriginal source
πŸ‡ΊπŸ‡ΈRegulatoryopen.fda.gov

Drug label update: omeprazole

Official structured record identifier: 28a0b4c8-3ad3-451c-a957-28aef5e3d8b5.

openFDA Drug LabelsOriginal source
πŸ‡ΊπŸ‡ΈRegulatoryopen.fda.gov

Drug label update: DRx Choice Children daytime Cough and Chest Congestion

Official structured record identifier: 25fff2a6-ecb1-4117-bd11-e5ec3e3d09a9.

openFDA Drug LabelsOriginal source
πŸ‡ΊπŸ‡ΈRegulatoryopen.fda.gov

Drug label update: Meclizine Hydrochloride

Official structured record identifier: 2518b0b6-35ab-49f4-936c-1eafea04b466.

openFDA Drug LabelsOriginal source
πŸ‡ΊπŸ‡ΈRegulatoryopen.fda.gov

Drug label update: Eczema Soothing Moisturizing Cream

Official structured record identifier: 23548524-2e2e-4d1a-9ebb-6f86d6279e93.

openFDA Drug LabelsOriginal source
πŸ‡ΊπŸ‡ΈRegulatoryopen.fda.gov

Drug label update: Advanced Healing

Official structured record identifier: 22bd8e87-965c-466b-bb9b-7d4753e500bc.

openFDA Drug LabelsOriginal source
πŸ‡ΊπŸ‡ΈRegulatoryopen.fda.gov

Drug label update: Antibacterial Lotions Skin Cleanser

Official structured record identifier: 1b2d1076-2c8b-8869-e063-6394a90a1ac4.

openFDA Drug LabelsOriginal source
πŸ‡ΊπŸ‡ΈRegulatoryopen.fda.gov

Drug label update: TheraTears

Official structured record identifier: 17a01236-130f-495b-9f8d-92b6a23b2dc5.

openFDA Drug LabelsOriginal source
πŸ‡ΊπŸ‡ΈRegulatoryopen.fda.gov

Drug label update: Levothyroxine Sodium

Official structured record identifier: 13e03769-9a4f-497f-9afa-95bf525090b3.

openFDA Drug LabelsOriginal source
πŸ‡ΊπŸ‡ΈRegulatoryopen.fda.gov

Drug label update: Dexamethasone Sodium Phosphate

Official structured record identifier: 11f10a47-1c42-40e4-89d8-bb000fef497c.

openFDA Drug LabelsOriginal source
πŸ‡ΊπŸ‡ΈRegulatoryopen.fda.gov

Drug label update: Colgate MaxFresh Knockout

Official structured record identifier: 0ffbb3a9-7bfa-4f6a-aef3-fde327a410c9.

openFDA Drug LabelsOriginal source
πŸ‡ΊπŸ‡ΈRegulatoryopen.fda.gov

Drug label update: Bumetanide

Official structured record identifier: 0fb78afc-d8bc-4ae8-8c0a-6d9c6f7a22c5.

openFDA Drug LabelsOriginal source
πŸ‡ΊπŸ‡ΈRegulatoryopen.fda.gov

Drug label update: Amlodipine Besylate and Benazepril Hydrochloride

Official structured record identifier: 0f253cac-67ac-4b03-b1a8-f2c345938dda.

openFDA Drug LabelsOriginal source
πŸ‡ΊπŸ‡ΈRegulatoryopen.fda.gov

Drug label update: SPIRONOLACTONE

Official structured record identifier: 0cc23419-e6d5-4036-8011-dc1d2455e0cb.

openFDA Drug LabelsOriginal source
πŸ‡ΊπŸ‡ΈRegulatoryopen.fda.gov

Drug label update: Ibuprofen

Official structured record identifier: 0ca02f8b-4413-4e7c-a67b-8c67c53e1343.

openFDA Drug LabelsOriginal source
πŸ‡ΊπŸ‡ΈRegulatoryopen.fda.gov

Drug label update: SENOKOT

Official structured record identifier: 0c6e6bdd-9f49-4550-b60a-8f58b7c0f090.

openFDA Drug LabelsOriginal source
πŸ‡ΊπŸ‡ΈRegulatoryopen.fda.gov

Drug label update: Nicotine

Official structured record identifier: 09bc9f57-fed2-42d9-b4f2-2b71b8baa0a9.

openFDA Drug LabelsOriginal source
πŸ‡ΊπŸ‡ΈRegulatoryopen.fda.gov

Drug label update: Bendamustine Hydrochloride

Official structured record identifier: 085dd54c-4212-d879-afef-ee52732a48c0.

openFDA Drug LabelsOriginal source
πŸ‡ΊπŸ‡ΈRegulatoryopen.fda.gov

Drug label update: Metformin

Official structured record identifier: 05999192-ebc6-4198-bd1e-f46abbfb4f8a.

openFDA Drug LabelsOriginal source
πŸ‡ΊπŸ‡ΈRegulatoryopen.fda.gov

Drug label update: unspecified product

Official structured record identifier: 004dd408-e3ff-4ba6-b859-beebe364f0e1.

openFDA Drug LabelsOriginal source
πŸ‡ΊπŸ‡ΈRegulatoryopen.fda.gov

Drug recall: TROKENDI XR

Official structured record identifier: 99767.

openFDA Drug RecallsOriginal source
πŸ‡ΊπŸ‡ΈRegulatoryopen.fda.gov

Drug recall: Broadway Joe's Pain Cream, (Histamine Dihydrochloride 0.025%), 1500mg CBD Isolate, 1000mg Hempseed oil, 2 oz-jar, Produced for Broadway Joe's, Franklin, TN, 37067, NDC 83088-8120-5, UPC 8 50041 64003 7

Official structured record identifier: 99751.

openFDA Drug RecallsOriginal source
πŸ‡ΊπŸ‡ΈRegulatoryopen.fda.gov

Drug recall: MYCOPHENOLATE MOFETIL

Official structured record identifier: 99750.

openFDA Drug RecallsOriginal source
πŸ‡ΊπŸ‡ΈRegulatoryopen.fda.gov

Drug recall: TRAZODONE HYDROCHLORIDE

Official structured record identifier: 99734.

openFDA Drug RecallsOriginal source
πŸ‡ΊπŸ‡ΈRegulatoryopen.fda.gov

Drug recall: PRASUGREL

Official structured record identifier: 99732.

openFDA Drug RecallsOriginal source
πŸ‡ΊπŸ‡ΈRegulatoryopen.fda.gov

Drug recall: THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 3ml - 0.1 fl. oz, Sachet: Single use only, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914.UPC 8 885014 073293

Official structured record identifier: 99652.

openFDA Drug RecallsOriginal source
πŸ‡ΊπŸ‡ΈRegulatoryopen.fda.gov

Drug recall: DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE

Official structured record identifier: 99551.

openFDA Drug RecallsOriginal source
πŸ‡ΊπŸ‡ΈRegulatoryopen.fda.gov

Drug recall: CLINDAMYCIN PHOSPHATE

Official structured record identifier: 99500.

openFDA Drug RecallsOriginal source
πŸ‡ΊπŸ‡ΈRegulatoryopen.fda.gov

Device recall: Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232. Software 4.1.10.x

Official structured record identifier: 99784.

openFDA Device RecallsOriginal source
πŸ‡ΊπŸ‡ΈRegulatoryopen.fda.gov

Device recall: Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ADULT BLOOD CULTURE KIT DYNDH1444D BLOOD CULTR KT DIVRSN DEVICE DYNDH1866 BLOOD CULTURE KIT DYNDH1462B DYNDH1622C DYNDH1622D DYNDH1622F DYNDH1715B DYNDH2028 DYNDH2048 BLOOD CULTURE-NB DYNDH2089 BLOOD DRAW KIT DY

Official structured record identifier: 99561.

openFDA Device RecallsOriginal source
πŸ‡ΊπŸ‡ΈRegulatoryopen.fda.gov

Device recall: Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS

Official structured record identifier: 99557.

openFDA Device RecallsOriginal source
πŸ‡ΊπŸ‡ΈRegulatoryopen.fda.gov

Device recall: 5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8

Official structured record identifier: 99556.

openFDA Device RecallsOriginal source