Healthcare news
Breaking news, regulatory updates, FDA / EMA / WHO / national health ministry announcements.
- FDA
CDER Small Business & Industry Assistance (SBIA)
A Comprehensive Resource for Information on Human Drug Development in Regulation
- FDA
Regulatory Education for Industry (REdI) Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products - 05/19/2026
Learn directly from the FDA’s regulatory experts in medical product centers: drugs, devices, and biologics.
- FDA
Prescription to Nonprescription Switch List
Prescription to Nonprescription Switch List
- FDA
What's New Related to Drugs
Want to know what's new on drugs from FDA? This page provides quick links to the latest on a variety of topics including: drug approvals, safety warnings, drug shortages, etc.
- FDA
Oncology (Cancer)/Hematologic Malignancies Approval Notifications
FDA does not issue approval announcements for every approval or drug label update that occurs in oncology and hematology. Please refer to Drugs@FDA for the latest approvals and prescribing information for specific products.
- FDA
FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic triple-negative breast cancer
FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic triple-negative breast cancer
- FDA
Drugs@FDA Data Files
Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)
- EMA
Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 19-21 May 2026
CVMP opinions on veterinary medicinal productsThe Committee adopted a positive opinion for a marketing authorisation for Nobivac NXT HC, for the active immunisation of …
- FDA
President's Emergency Plan for AIDS Relief (PEPFAR)
Presidential Emergency Plan for AIDS Relief content
- EMA
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 May 2026
Eight new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended eight medicines for approval at its May 2026 meeting.Jascayd (nerandomilast)…, CHMP statistics Key figures from the May 2026 CHMP meeting are represented in the graphic below. , CHMP statistics:…, Positive recommendations on new medicines, Boey INN trenibotulinumtoxinE Marketing authorisation applicant AbbVie Deutschland GmbH Co Therapeutic indication Temporary improvement in the…, Etcamah INN camizestrant Marketing authorisation applicant Astra Zeneca Therapeutic indication Etcamah in combination with a CDK4/6 inhibitor (palbociclib,…, Jascayd INN nerandomilast Marketing authorisation applicant Boehringer Ingelheim International GmbH Therapeutic indication Treatment of adult…, Vijoice INN alpelisib Marketing authorisation applicant Novartis Europharm Limited Therapeutic indication Vijoice is indicated for the treatment of…, Positive recommendations on new hybrid medicines, Ablymico INN liraglutide Marketing authorisation applicant STADA Arzneimittel AG Therapeutic indication Treatment of diabetes and weight…, Liraglutide STADA INN liraglutide Marketing authorisation applicant STADA Arzneimittel AG Therapeutic indication Treatment of adults, adolescents…, Colchicine AGEPHA Pharma INN colchicine Marketing authorisation applicant Agepha Pharma s.r.o. Therapeutic indication Indicated to reduce the risk of…, Positive recommendations on new biosimilar medicine, Vislyfa INN ranibizumab Marketing authorisation applicant Lupin Europe GmbH Therapeutic indication The treatment of neovascular (wet) age-related…, Negative recommendations on new medicines, Deqtynet INN copper (64Cu) oxodotreotide Marketing authorisation applicant Cis Bio International Therapeutic indication For positron emission…, Positive recommendations on extensions of therapeutic indications , Braftovi INN encorafenib Marketing authorisation holder Pierre Fabre Medicament More information Braftovi : pending EC decision, Enhertu INN trastuzumab deruxtecan Marketing authorisation holder Daiichi Sankyo Europe GmbH More information Enhertu: pending EC decision (EMA/VR/…, Erbitux INN cetuximab Marketing authorisation holder Merck Europe B.V. More information Erbitux: pending EC decision (EMA/VR/0000326978)Erbitux:…, Fasenra INN benralizumab Marketing authorisation holder AstraZeneca AB More information Fasenra: pending EC decision, Hetronifly INN serplulimab Marketing authorisation holder Accord Healthcare S.L.U. More information Hetronifly: pending EC decision, Iclusig INN ponatinib Marketing authorisation holder Incyte Biosciences Distribution B.V. More information Iclusig: pending EC decision, Keytruda INN pembrolizumab Marketing authorisation holder Merck Sharp Dohme B.V. More information Keytruda: pending EC decision (EMA/VR/…, Maviret INN glecaprevir / pibrentasvir Marketing authorisation holder AbbVie Deutschland GmbH Co. KG More information Maivret : pending EC…, Padcev INN enfortumab vedotin Marketing authorisation holder Astellas Pharma Europe B.V. More information Padcev : pending EC decision, Palynziq INN pegvaliase Marketing authorisation holder BioMarin International Limited More information Palynziq : pending EC decision, Sogroya INN somapacitan Marketing authorisation holder Novo Nordisk A/S More information Sogroya : pending EC decision, Tepkinly INN epcoritamab Marketing authorisation holder AbbVie Deutschland GmbH Co. KG More information Tepkinly : pending EC decision, Trodelvy INN sacituzumab govitecan Marketing authorisation holder Gilead Sciences Ireland Unlimited Company More information Trodelvy : pending EC…, Withdrawal of initial marketing authorisation applications, Veblocema INN infliximab Marketing authorisation holder Celltrion Healthcare Hungary Kft. More information Veblocema : questions and answers, Orblid INN bevacizumab Marketing authorisation holder Laboratoires Delbert More information Orblid : questions and answers, Other updates, Wegovy INN semaglutide Marketing authorisation holder Novo Nordisk A/S More information Wegovy : pending EC decision (EMA/X/0000296344) News…, Overview of (invented) names reviewed in April 2026 by the Name Review Group (NRG) adopted at the…
- EMA
New medicine for two types of pulmonary fibrosis
EMA has recommended granting a marketing authorisation in the European Union (EU) for Jascayd (nerandomilast) to treat adults with idiopathic pulmonary fibrosis (IPF) or…
- WHO
Seventy-ninth World Health Assembly – Daily update: 21 May 2026
Summary of discussions of 21 May at the Seventy-ninth World Health Assembly.
- FDA
GDUFA Paid Facilities List
This list contains GDUFA facility payments received by the Agency. Data are extract from the User Fee System and GDUFA Facility User Fee Coversheets. The following table explains the terms used in the list:
- WHO
Seventy-ninth World Health Assembly – Daily update: 20 May 2026
Summary of discussions of 20 May at the Seventy-ninth World Health Assembly.
- MedlinePlus
Hantavirus Pulmonary Syndrome
Source: Mayo Foundation for Medical Education and ResearchRelated MedlinePlus Pages: Hantavirus Infections
- MedlinePlus
Hantavirus Infection
Source: Merck & Co., Inc.Related MedlinePlus Pages: Hantavirus Infections
- FDA
Prescription Drug User Fee Amendments
The Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 and authorizes FDA to collect fees from companies that produce certain human drug and biological products. Since the passage of PDUFA, user fees have played an important role in expediting the drug approval process.
- FDA
Human Drug Compounding Outsourcing Facility Fees
Human Drug Compounding Outsourcing Facility Fees
- cdc
Kettle Cuisine Issues Allergy Alert For Undeclared Shrimp In Whole Foods Market Kitchen Minestrone Soup
Kettle Cuisine of Lynn, MA is recalling 24oz cups of Whole Foods Market Kitchen Minestrone Soup which may contain undeclared shrimp. People who have allergies to Crustacean Shellfish (Shrimp) run the risk of serious or life-threatening allergic reaction if they consume this product.
- cdc
JXK Enterprises, Inc Issues Voluntary Nationwide Recall of Boner Bears Chocolate Due to Undeclared Sildenafil
JXK Enterprises, Inc is voluntarily recalling Boner Bears Chocolate, Lot #BB21125, after being notified that FDA laboratory analysis confirmed the presence of sildenafil, an active ingredient in the FDA-approved prescription drug Viagra, which is not declared on the product label.
- EMA
EMA closed on Whit Monday, 25 May
EMA’s office is closed on 25 May, to mark Whit Monday. The office reopens 08:30 on Tuesday, 26 May.The product emergency hotline is available outside working hours and on…
- FDA
Ventilator Recall: React Health Removes VOCSN V+Pro Ventilators
React Health is removing affected devices due to a manufacturing process deviation that may result in an undetected oxygen leak condition.
- FDA
Automated Compounding System Recall: Omnicell Removes Syringe Labels Used with the i.v.STATION Automated Compounding System
Certain labels used with i.v.STATION automated compounding systems may not be detected, leading to mislabeled sterile filled syringes.
- FDA
Early Alert: Heart Pump Controller Issue from Abiomed
A software error may cause the Automated Impella Controller to restart when used in conjunction with left ventricular Impella devices.
- MedlinePlus
How Monkeypox Spreads
Source: Centers for Disease Control and PreventionRelated MedlinePlus Pages: Mpox