Drugs

Approval based on results from the Phase 3 KEYNOTE-859 trial, which demonstrated significant improvement in overall survival in these patients versus chemotherapy alone Approval marks seventh gastrointestinal cancer indication for Keytruda -based regimens and 38th indication for Keytruda in the US RAHWAY, N.J.–(BUSINESS WIRE) November 16, 2023 — Merck (NYSE: MRK), known as MSD outside

November 8, 2023 Audience: Consumer November 8, 2023 – Maryland Heights, MO, SugarMDs, LLC is voluntarily recalling Lot: 22165-003 Advance Glucose Support Supplement in 60, 120 and 180 count bottles to the consumer level. FDA analysis has found the product to be tainted with glyburide and metformin. Glyburide and Metformin are active ingredients found in

Treatment for: Cough Merck Provides Update on FDA Advisory Committee Meeting Evaluating Gefapixant RAHWAY, N.J., Nov. 17, 2023 – Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the outcome of the U.S. Food and Drug Administration (FDA) Pulmonary-Allergy Drugs Advisory Committee (PADAC) meeting, which discussed the New Drug

FDA Approves Zepbound (tirzepatide) for Chronic Weight Management INDIANAPOLIS, Nov. 8, 2023 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) approved Eli Lilly and Company’s (NYSE: LLY) Zepbound™ (tirzepatide) injection, the first and only obesity treatment of its kind that activates both GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) hormone receptors. Zepbound is

November 13, 2023 Audience: Consumers, Pharmacy November 13, 2023, Los Angeles, California – KinderFarms, LLC is voluntarily recalling all lots of KinderMed Infants’ Pain & Fever (oral suspension) and KinderMed Kids’ Pain & Fever (oral suspension) to the retail and consumer level. These products are being voluntarily recalled due to acetaminophen instability. The two products

FDA Approves Truqap (capivasertib) plus Faslodex for Patients with Advanced HR-Positive Breast Cancer 17 November 2023 — AstraZeneca’s Truqap (capivasertib) in combination with Faslodex (fulvestrant) has been approved in the US for the treatment of adult patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations (PIK3CA,

Moorfields Eye Hospital London experts, led by Pearse Keane, have developed an Artificial Intelligence tool to provide a fast and reliable diagnosis for patients with eye-related diseases.  In recent years, there has been a rapid push to integrate artificial intelligence (AI) into healthcare systems. Artificial Intelligence (AI) serves to train a machine to make precise, swift

FDA Approves Augtyro (repotrectinib) for the Treatment of Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer (NSCLC) PRINCETON, N.J.–(BUSINESS WIRE)– Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Augtyro (repotrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer

November 15, 2023 Audience: Consumers November 13, 2023– Mumbai, Maharashtra, Kilitch Healthcare India Limited is voluntarily recalling the eye drops products listed in the table below to the consumer level with all lots within expiry with expiration dates ranging from November, 2023 to September, 2025 for all the below mentioned products. These products are being

FDA Approves DefenCath (taurolidine and heparin) to Reduce the Incidence of Catheter-Related Bloodstream Infections in Adult Hemodialysis Patients Berkeley Heights, NJ – November 15, 2023 – CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening diseases and conditions, today announced that the U.S. Food

Treatment for: Sickle Cell Disease CRISPR Therapeutics Announces Completion of FDA Advisory Committee Meeting for Exagamglogene Autotemcel (exa-cel) for Severe Sickle Cell Disease Exa-cel PDUFA target action date is December 8, 2023 for severe sickle cell disease (SCD) ZUG, Switzerland and BOSTON, Oct. 31, 2023 (GLOBE NEWSWIRE) — CRISPR Therapeutics (Nasdaq: CRSP) today announced the

Exparel is the only FDA-approved single-dose regional analgesic to safely demonstrate four days of superiority versus bupivacaine in two clinical studies — New indications for use as an adductor canal block and sciatic nerve block in the popliteal fossa will significantly extend reach within more than 3 million lower extremity procedures TAMPA, Fla., Nov. 10,

OSAKA, Japan & CAMBRIDGE, Mass., November 09, 2023–(BUSINESS WIRE)–Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved Adzynma (ADAMTS13, recombinant-krhn) for the prophylactic and on-demand treatment of adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP). Adzynma is the first and only FDA-approved recombinant ADAMTS13 (rADAMTS13) protein designed to

FDA Approves Ixchiq (Chikungunya Vaccine, Live) for the Prevention of Disease Caused by Chikungunya Virus Saint-Herblain (France), November 10, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the U.S. Food and Drug Administration (FDA) has approved Ixchiq®, Valneva’s single-dose, live-attenuated vaccine indicated for the prevention of disease

FDA Approves Fruzaqla (fruquintinib) for Previously Treated Metastatic Colorectal Cancer Fruzaqla is the First Targeted Therapy Approved for Metastatic Colorectal Cancer (mCRC) Regardless of Biomarker Status or Prior Types of Therapies in More Than a Decade Fruzaqla Plus Best Supportive Care Demonstrated Significant Improvements in Overall Survival, with Corresponding Improvements in Progression Free Survival, Versus

November 3, 2023 Audience: Consumers November 3, 2023 — Consumers should not purchase or use Dr. Ergin’s SugarMD Advanced Glucose Support, a product promoted and sold for blood glucose management. It may have been purchased at www.sugarmds.com and possibly in some retail stores due to hidden drug ingredients. FDA laboratory analysis confirmed that Dr. Ergin’s

FDA Approves Zituvimet (sitagliptin and metformin hydrochloride) to Treat Adult Patients With Type 2 Diabetes Mellitus November 06, 2023, Ahmedabad, India — Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as “Zydus”) today announced that the U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for Zituvimet (Sitagliptin and Metformin hydrochloride)

November 6, 2023 Audience: Pharmacy, Healthcare Professional On November 6, 2023, Nurse Assist, LLC initiated a voluntary recall of 0.9% sodium chloride irrigation USP and sterile water for irrigation USP, due to the potential for a lack of sterility assurance, which could result in a nonsterile product. In populations most at risk, such as patients

Generic name: etripamilTreatment for: Paroxysmal Supraventricular Tachycardia Milestone Pharmaceuticals Announces Submission of New Drug Application to the U.S. FDA for Etripamil Submission seeks approval for treatment of an abnormal heart rhythm, Paroxysmal Supraventricular Tachycardia or PSVT Comprehensive data package includes positive results from pivotal Phase 3 RAPID trial which Company believes demonstrates new calcium channel

FDA approval based on robust Phase III data in which Cosentyx® (secukinumab) showed rapid relief from symptoms of hidradenitis suppurativa (HS) as early as Week 21 As the only IL-17A inhibitor approved for HS, Cosentyx offers a meaningful new treatment option that demonstrated reductions in inflammatory nodules and abscesses, and flares2 HS is a chronic,

October 31, 2023 Audience: Consumer, Health Professional, Ophthalmology, Pharmacy October 31, 2023 – Dublin, OH, Cardinal Health, Inc. is initiating a voluntarily recall for all lots of ophthalmic products supplied by Velocity Pharma, LLC to the consumer level. Cardinal Health, Inc. received information from FDA indicating investigators found insanitary conditions in the manufacturing facility and

Treatment for: Anemia Associated with Chronic Renal Failure Akebia Receives FDA Acceptance of Resubmission to NDA of Vadadustat for the Treatment of Anemia due to Chronic Kidney Disease CAMBRIDGE, Mass., Oct. 25, 2023 /PRNewswire/ — Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney

October 31, 2023 — Today, the U.S. Food and Drug Administration approved Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) for multiple inflammatory diseases. Wezlana, like Stelara, is approved to treat the following indications: Adult patients with: moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; active psoriatic

October 31, 2023 Audience: Consumer, Health Professional, Ophthalmology, Pharmacy October 31, 2023 – La Vergne, TN, The Harvard Drug Group, LLC d/b/a Major® Pharmaceutical and Rugby® Laboratories is initiating a voluntarily recall for all lots of Polyvinyl Alcohol, 1.4% Lubricating Eye Drops and Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%) supplied by Velocity Pharma, LLC to

Generic name: apomorphineTreatment for: Hypomobility in Parkinson’s Disease Supernus Announces SPN-830 Apomorphine Infusion Device NDA Accepted for Review by FDA ROCKVILLE, Md., Nov. 02, 2023 (GLOBE NEWSWIRE) — Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced that the

Have you found yourself making more trips to the bathroom than usual? Are your stools a bit more watery and loose than they should be? It sounds like you’re experiencing diarrhea. But what is it, and why are you suffering from it? Do I have diarrhea? The symptoms of diarrhea are: Frequent, watery stools, typically

RAHWAY, N.J.–(BUSINESS WIRE) November 1, 2023 — Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, in combination with gemcitabine and cisplatin, for the treatment of patients with locally advanced unresectable or metastatic biliary tract

November 1, 2023 Audience: Healthcare Providers November 1, 2023 — The Food and Drug Administration (FDA) is advising healthcare providers who administer the Moderna COVID-19 Vaccine (2023-2024 Formula) to individuals 6 months through 11 years of age to ensure that the correct volume of the vaccine (0.25 mL) is withdrawn from the vial, so that