RX Note

JULY 22, 2025

External Links Garis Panduan Kaunseling Ubat-ubatan, 2025 Sarawak General Hospital Pharmacy - Counseling Points HKL Counseling Checklist HTAR Pharmacy Handbook e-IMBAS The least we could do, 2023

Patient Counseling 52

Patient Counseling Adverse Reactions Communication Inpatient 52

FDA Law Blog: Biosimilars

APRIL 7, 2025

Further, information presented on the adverse reaction data was inconsistent with the PI. The Warning Letter alleged that the veterinarian product website made claims about a Vaccine Safety Study relied upon for approval that directly conflict with the PI. that it is effective on Day 1) and insinuating misleading comparative claims.

Vaccines 64

Vaccines Adverse Reactions 64

The Thyroid Pharmacist

MARCH 7, 2025

A 2023 study found that low-dose glyphosate exposure altered the gut microbiota in such a way that increased pro-inflammatory cells and markers of intestinal inflammation. [21] An adverse reaction to mold can be a trigger for Hashimotos, asthma, and other autoimmune conditions. [23] Accessed August 29, 2023. May 5, 2020.

Health and Personal Care Stores 67

Health and Personal Care Stores Labelling Immunization Immunity 67

Pharmacy Times

JULY 18, 2025

1,2 The most common adverse reactions are abdominal pain, diarrhea, dizziness, flatulence, headache, nausea, soft feces, vomiting, and vulvovaginal candidiasis. The use of gepotidacin in pregnancy and breastfeeding has not been evaluated. It has not been studied in patients younger than 12 years or who weigh less than 40 kg.

Pharmacy Technician 26

Pharmacy Technician Compounding Pharmacies Pharmacy Management Adverse Reactions 26

The Pharmacist

MAY 26, 2023

A genetic ‘biobank’ will be launched on 1 June 2023 by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to understand how a patient’s genetic make up can impact the safety of their medicines.

Adverse Reactions 98

Adverse Reactions 98

European Pharmaceutical Review

OCTOBER 18, 2023

However, in the trials, the only observed adverse reaction for the treatment was diarrhoea. XPHOZAH is expected to be available to eligible patients in the US in November 2023. Overall, the data showed that XPHOZAH significantly reduced elevated serum phosphorus in patients receiving maintenance hemodialysis.

Adverse Reactions 119

Adverse Reactions Labelling 119

European Pharmaceutical Review

JANUARY 18, 2023

To date, most solicited adverse reactions were mild or moderate. The most commonly reported solicited adverse reactions in the mRNA-1345 group were injection site pain, fatigue, headache, myalgia, and arthralgia. Based on the study results, Moderna intends to submit for regulatory approval in the first half of 2023.

Vaccines 105

Vaccines Adverse Reactions 105

European Pharmaceutical Review

JANUARY 8, 2024

New European approval for generalised myasthenia gravis treatment EC approval of rozanolixizumab is supported by data from the Phase III MycarinG study , published in The Lancet Neurology in May 2023, according to UCB. Healthcare professionals are asked to report any suspected adverse reactions.

Adverse Reactions 98

Adverse Reactions 98

LifeProNow

MARCH 10, 2023

March 10, 2023: “Pfizer Inc. The most common adverse reactions reported in at least 2% of patients treated with ZAVZPRET and at a frequency greater than placebo were taste disorders (includes dysgeusia and ageusia), nausea, nasal discomfort and vomiting. ZAVZPRET is anticipated to be available in pharmacies in July 2023.

Adverse Reactions 100

Adverse Reactions 100

European Pharmaceutical Review

FEBRUARY 21, 2023

SYFOVRE is expected to be available by the beginning of March 2023. The safety profile of SYFOVRE is well-demonstrated following ~12,000 injections. A marketing authorisation application (MAA) is under review by the European Medicines Agency (EMA) with a regulatory decision expected in early 2024.

Adverse Reactions 98

Adverse Reactions 98

Pharma Times

JULY 21, 2025

Adverse reactions in adults included dermatitis acneiform, diarrhoea, nausea and musculoskeletal pain. In children, reactions included elevated blood creatine phosphokinase, abdominal pain, vomiting and headache. EZMEKLY is available in tablet form that dissolves in water, helping those unable to swallow pills.

Adverse Reactions 86

Adverse Reactions 86

PharmaShots

JUNE 6, 2023

with no new safety signals, the discontinuation rate due to adverse reactions (6% vs 4%) Ref: Gilead | Image: Gilead Related News:- Gilead and Arcus Present P-II Study (ARC-7) Results of Domvanalimab as 1L Treatment of Non-Small Cell Lung Cancer at ASCO 2023 PharmaShots! vs 11.2mos.), PFS rates at 6/12/18mos. vs 29.4%)/ (21.7%

Adverse Reactions 40

Adverse Reactions Chemotherapy 40

Pharmaceutical Technology

JUNE 13, 2023

Somnolence and headache are the most frequently reported adverse reactions observed in clinical trials. In May 2023, Health Canada granted marketing authorisation for Quviviq.

Adverse Reactions 52

Adverse Reactions 52

Big Molecule Watch

SEPTEMBER 25, 2023

Last week, FDA released a draft guidance, “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “ Labeling for Biosimilar Products.” The fictitious example provided in the 2023 Draft Guidance is “NEXSYMEO.”

Labelling 49

Labelling Biosimilars Adverse Reactions Dosage 49

European Pharmaceutical Review

NOVEMBER 10, 2023

The Phase III results were published in The Lancet in June 2023. In October 2023, Valneva submitted a marketing application for the chikungunya vaccine to the European Medicines Agency (EMA), which included initial safety data from the trial. IXCHIQ-induced seroresponse was sustained over time with a 96.3

Vaccines 52

Vaccines Adverse Reactions Immunization Immunity 52

LifeProNow

MARCH 28, 2023

The most commonly reported adverse reaction was upper respiratory infections (18.9%), most frequently nasopharyngitis. The results are particularly meaningful for dermatologists and patients who have been waiting for a more effective and convenient oral therapy to help manage this serious, chronic, immune-mediated disease.”

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Adverse Reactions Immunization Immunity Labelling 130

LifeProNow

MAY 8, 2023

May 8, 2023: “ Koselugo (selumetinib) has been approved in China for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in paediatric patients with neurofibromatosis type 1 (NF1) aged three years and above.

Adverse Reactions 100

Adverse Reactions Hospitals 100

RX Note

JUNE 28, 2023

Adverse Reactions All GLP-1 receptor agonists have been associated with nausea and other gastrointestinal disturbances. Method of Administration GLP-1 agonists are mostly administered by subcutaneous injection , either Once daily Exenatide, liraglutide, lixisenatide Once weekly Extended release exenatide, albiglutide, dulaglutide.

Adverse Reactions 40

Adverse Reactions Diabetes 40

Putting Patients First Blog

APRIL 4, 2024

Introduced by Senator Lisa Murkowski (R-AK) in March 2023, the Safe Step Act aims to reform step therapy protocols in health plans. In May 2023, the Safe Step Act was passed through the Senate Health, Education, Labor, and Pensions (HELP) Committee as an amendment to the Pharmacy Benefit Manager Reform Act.

Adverse Reactions 52

Adverse Reactions Diabetes 52

Putting Patients First Blog

APRIL 4, 2024

Introduced by Senator Lisa Murkowski (R-AK) in March 2023, the Safe Step Act aims to reform step therapy protocols in health plans. In May 2023, the Safe Step Act was passed through the Senate Health, Education, Labor, and Pensions (HELP) Committee as an amendment to the Pharmacy Benefit Manager Reform Act.

Adverse Reactions 40

Adverse Reactions Diabetes 40

epicur

AUGUST 24, 2023

Many animals experience anxiety or have adverse reactions when taken to a clinic. Read More » Event Recap: ACVO/Epicur National Service Animal Eye Exam 2023 July 19, 2023 No Comments It was another great year of the ACVO/Epicur National Service Animal Eye Exam Event!

Adverse Reactions 52

Adverse Reactions Packaging 52

The Thyroid Pharmacist

DECEMBER 29, 2023

I can’t believe that it’s been over 10 years since I started the thyroidpharmacist.com blog in 2013, and now 2023 is almost over. 2023 was probably the second or third most creative/productive year for me in the last decade, in terms of creating healing resources and just overall intensity (I’ll share more details below).

Adverse Reactions 82

Adverse Reactions Immunization Immunity Diabetes 82

RX Note

JUNE 9, 2023

Category D - There is positive evidence of human foetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. If yes, is there a preferred alternative?

Adverse Reactions 52

Adverse Reactions Labelling 52

Birth Control Pharmacist

SEPTEMBER 20, 2021

Adverse Reactions. The most common adverse reactions (>2%) were bleeding irregularities, dysmenorrhea, headaches, mood disturbance, increase weight, acne, decrease libido and breast symptoms. As the BMI increased in the women participating in the study, the Pearl Index also increased. 2020, [link]. About the Authors.

Adverse Reactions 52

Adverse Reactions Packaging Labelling Diabetes 52

European Pharmaceutical Review

DECEMBER 27, 2023

After this incident CAR-related toxicity scales and guidelines were established to prevent adverse reactions. FDA; 2022 [cited 2023 Mar]. Overview of approved car‐t therapies, ongoing clinical trials, and its impact on clinical practice. 2021;3(S1):6–10. Center for Biologics Evaluation and Research.

Adverse Reactions 104

Adverse Reactions Immunization Immunity Medical Schools 104

The Thyroid Pharmacist

JUNE 30, 2023

IW: What are some of the more common adverse reactions that people have to LDN? Published 2023 Mar 31. For people who are new to LDN or for those with swallowing issues (dysphagia), I will usually recommend starting with a liquid formulation. That allows us to figure out the correct dose for each person. Published 2018 Sep 21.

Compounding 98

Compounding Immunization Immunity Compounding Pharmacies 98

PharmaState Academy

MARCH 5, 2024

This quiz competition is brought to you by Now & Next Summit on Pharma Marketing scheduled for 28th Oct 2023 at The Westin, Goregaon, Mumbai. Once you're a winner, you will not be considered for the prizes for another two months. How to Participate? The Quiz has to be attempted in a single go.

Adverse Reactions 52

Adverse Reactions 52

LifeProNow

APRIL 9, 2023

April 04, 2023: “Pfizer announced that the U.S. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in Fourth-Quarter 2023 for the sNDAs. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in Fourth-Quarter 2023 for the sNDAs. In the U.S., of patients.

Adverse Reactions 100

Adverse Reactions Labelling Documentation 100

pharmaphorum

JANUARY 26, 2023

2023 is set to usher in a new era of genomics, and here are five areas where we should see significant advances. Moreover, research has shown that genetic testing can reduce adverse reactions to drugs by nearly one third. The post A new dawn of the genomic age: five areas set to be transformed in 2023 appeared first on.

Adverse Reactions 129

Adverse Reactions Vaccines 129

PharmaShots

JUNE 26, 2023

from completion of or are refractory to 1L chemoimmunotherapy The approval was based on the P-III trial (TRANSFORM) evaluating Breyanzi vs SoC in 184 patients which showed improved EFS with a manageable and well-established safety profile, m-EFS (10.1 vs 2.3mos.) at the time of prespecified interim analysis with a median follow-up of 6.2mos.

Adverse Reactions 40

Adverse Reactions Hospitals 40

LifeProNow

APRIL 19, 2023

April 17, 2023: “The U.S. The most common adverse reactions associated with Omisirge included infections, GvHD, and infusion reactions.

Adverse Reactions 130

Adverse Reactions Chemotherapy Labelling Immunization 130

PharmaShots

FEBRUARY 15, 2023

Shots: The US FDA approved 8 NDAs and 1 BLA in January 2023, leading to treatments for patients and advances in the healthcare industry. insurance coverage & co-pay programs. or as adjunctive therapy to lithium or valproate for bipolar I disorder in adults Rykindo is a long-acting risperidone inj.

Adverse Reactions 40

Adverse Reactions Diabetes 40

The Thyroid Pharmacist

SEPTEMBER 1, 2023

Who is Likely to Have an Adverse Reaction to Fluoride, and What are the Symptoms? Accessed August 9, 2023. Accessed August 9, 2023. Accessed August 29, 2023. Accessed August 29, 2023. Published 2023 Jul 8. 30] If you live in the U.S., 2012;39(7):2881-2915. doi:10.1007/s11164-012-0841-1. [2]

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Adverse Reactions Compounding Chemotherapy Labelling 116

The Thyroid Pharmacist

SEPTEMBER 8, 2023

Or, you may invest in some supplements and medications, only to discover you have an adverse reaction to them. Or, you may even be scared to try a new intervention in case you have an adverse reaction to it. Treasure Island (FL): StatPearls Publishing; May 1, 2023. [2] Published 2023 Feb 20. Can you relate?

Health and Personal Care Stores 98

Health and Personal Care Stores Adverse Reactions Compounding Immunization 98

PharmaShots

JUNE 23, 2023

The EC’s decision on an additional indication is expected in 2023 The opinion was based on the P-III study (TROPiCS-02) evaluating Trodelvy vs CT in 543 patients which showed a clinical OS benefit of 3.2mos., Shots: The EMA’s CHMP has adopted a positive opinion for Trodelvy as monotx. m-OS (14.4 vs 11.2mos.),

Adverse Reactions 40

Adverse Reactions 40

The Thyroid Pharmacist

SEPTEMBER 29, 2023

21] A 2023 study in Northwest China determined that the incidence of thyroid nodules was significantly higher in those with persistent H. Accessed August 21, 2023. Accessed August 21, 2023. Accessed August 21, 2023. Published 2023 Mar 24. pylori infections – H. A 2013 study found that H. pylori infections. [22]

Immunization 98

Immunization Immunity Diabetes Adverse Reactions 98

LifeProNow

APRIL 30, 2023

April 29, 2023: “Astellas Pharma Inc. Food and Drug Administration (FDA), to support a potential regulatory submission for XTANDI in this indication in 2023. and Pfizer Inc. The overall safety profile was consistent with the known safety profile of each of the medicines.

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Adverse Reactions Chemotherapy Diabetes 130