The U.S. Food and Drug Administration recently approved two new oral medicines to treat a common sexually transmitted infection called gonorrhea.

Regla María Garci Espejo recounts growing up alongside her sister, who lived with a severe early-onset form of epilepsy. The post Growing up with a sister with West syndrome appeared first on EURORDIS-Rare Diseases Europe.

Seven new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended seven medicines for approval at its December 2025 meeting.The committee…, CHMP statistics Key figures from the December 2025 CHMP meeting are represented in the graphic below. , CHMP statistics:…, Positive recommendations on new

EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Anktiva (nogapendekin alfa inbakicept) to treat adults with a type of…

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 20 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

The Food and Drug Administration (FDA or Agency) has determined that BACTROBAN (mupirocin) nasal ointment, 2%, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for mupirocin nasal ointment, 2%, if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.

The Food and Drug Administration (FDA or Agency) has determined that LUNELLE (estradiol cypionate and medroxyprogesterone acetate) injectable, 5 milligrams (mg)/0.5 milliliter (mL) estradiol cypionate and 25 mg/0.5 mL medroxyprogesterone acetate, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for estradiol cypionate and medroxyprogesterone acetate injectable, 5 mg/0.5 mL estradiol cypionat

The Food and Drug Administration (FDA or Agency) has determined that ZANTAC (ranitidine hydrochloride (HCl)) injection, equivalent to (EQ) 25 milligram (mg) base/milliliter (mL), has not been withdrawn from sale for reasons of safety or effectiveness to the extent that the drug can be manufactured or formulated in a manner that satisfies any applicable acceptable intake limit for nitrosamine impurities. This determination means that FDA will not begin procedures to withdraw approval of abbreviat

In response to an over-the-counter (OTC) monograph order request (OMOR), the Food and Drug Administration (FDA) is announcing the availability on its website of the proposed administrative order (proposed order) (OTC000039) entitled "Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use." This proposed order, if finalized, will amend Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use (OTC Monograph M020) to add bemot

The Food and Drug Administration (FDA or Agency) is issuing this notice to request that public stakeholders--including patient and consumer advocacy groups--notify FDA of their intent to participate in periodic consultation meetings on the reauthorization of the Biosimilar User Fee Act (BsUFA). The statutory authority for BsUFA expires in September 2027. At that time, new legislation will be required for FDA to continue collecting biosimilar biological product user fees in future fiscal years. T

This Policy establishes expectations for ensuring the security of human biospecimens whose collection, obtainment, storage, use, or distribution are supported by NIH funds. The policy ensures protections for human participants and vital national security interests, consistent with Executive Order 14117 (see: https://www.govinfo.gov/ content/pkg/FR-2024-03-01/pdf/2024-04573.pdf) and 28 CFR 202 "Preventing Access to U.S. Sensitive Personal Data and Government- Related Data by Countries of Concern

EMA welcomes the landmark political agreement reached by the European Commission, the European Parliament and the Council of the European Union on the comprehensive reform of…, Today marks a historic milestone for European medicines regulation and for patients across the EU. The revamp of the pharmaceutical legislation will enable EMA and the…, The new legislation will modernise how medicines are developed, authorised and made available to patients across the EU. It is expected to simp

Today, the U.S. Food and Drug Administration announced that it is taking action to advance sunscreen innovation, part of a broader initiative in the Office of Nonprescription Drugs. The agency is proposing to add bemotrizinol as a permitted active ingredient for use in sunscreens.

EURORDIS welcomes EU institutions’ final agreement on reforms to the bloc’s General Pharmaceutical Legislation The post EURORDIS welcomes final agreement on the EU Pharma Package  appeared first on EURORDIS-Rare Diseases Europe.

This proposed rule would update and revise the Increasing Organ Transplant Access (IOTA) Model for Performance Year (PY) 2.

The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces the opening of a docket to obtain comment on the Draft Infection Control in Healthcare Personnel: Epidemiology and Control of Selected Infections Transmitted Among Healthcare Personnel and Patients: Conjunctivitis Section ("Draft Guideline"). The Draft Guideline includes updates to the Guideline for infection control in health care personnel, 1998 ("1998 Guideline"), Part E: Epidem

The Food and Drug Administration (FDA, the Agency, or we) is announcing a request for information from interested parties and the public to share their perspectives with FDA on testosterone replacement therapy for men. The Agency intends to use the information submitted to help inform considerations related to testosterone therapy for men.

How EURORDIS' contributions are shaping the partnership's development. The post Joining the Dots: EURORDIS’ role in ERDERA and the reshaping of rare disease research  appeared first on EURORDIS-Rare Diseases Europe.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers." The guidance addresses questions that manufacturers, packers, distributors, and their representatives (firms) may have when developing FDA-regulated promotional labeling and advertisements (p