Drugs

surufatinib Treatment for Neuroendocrine Carcinoma U.S. FDA Accepts Filing of Hutchmed’s NDA for Surufatinib for the Treatment of Advanced Neuroendocrine Tumors Hong Kong, Shanghai & Florham Park, NJ — Thursday, July 1, 2021: Hutchmed (China) Limited (“Hutchmed”) (Nasdaq/AIM: HCM; HKEX: 13) today announces that the U.S. Food and Drug Administration (“FDA”) has accepted its filing

TITUSVILLE, N.J. – July 30, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved Uptravi (selexipag) injection for intravenous (IV) use for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adult patients with WHO functional class (FC) II–III, who

Treatment for Prader-Willi Syndrome FDA Grants Priority Review for Levo Therapeutics’ New Drug Application for LV-101 (Intranasal Carbetocin) for the Treatment of Prader-Willi Syndrome CHICAGO, IL, July 6, 2021 (Newswire.com) – Levo Therapeutics, Inc., a biotechnology company dedicated to using genetic insights to advance treatments for Prader-Willi syndrome (PWS) and related disorders, announced today that the

KENILWORTH & WOODCLIFF, N.J.–(BUSINESS WIRE) July 22, 2021 — Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the combination of Keytruda, Merck’s anti-PD-1 therapy, plus Lenvima, the orally available multiple receptor tyrosine kinase inhibitor discovered by

News New Drug Applications FDA Accepts Braeburn’s New Drug Application Resubmission for Brixadi (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder Treatment for Opiate Dependence FDA Accepts Braeburn’s New Drug Application Resubmission for Brixadi (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder Plymouth Meeting, Pa. – June 26, 2021

Study reports a reduction in symptoms of menopause without the use of drugs through a plant-based diet and whole soybeans. In Western countries, up to 80% of postmenopausal women suffer from vasomotor symptoms, commonly referred to as hot flashes. Hot flashes cause peripheral vasodilation producing sensations of warmth in the face, neck, and chest, as

SILVER SPRING, Md., July 28, 2021 /PRNewswire/ — Today, the U.S. Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. Semglee (insulin glargine-yfgn) is both biosimilar to, and interchangeable with (can be

News FDA Alerts FDA Alerts Patients and Health Care Professionals About Clinical Trial Results Showing an Increased Risk of Death Associated with Pepaxto (melphalan flufenamide) July 28, 2021 Audience: Patients, Health Care Professionals July 28, 2021 — FDA is alerting patients and health care professionals that a clinical trial (OCEAN, Study OP-103) evaluating Pepaxto (melphalan

It is estimated that 1 in 11 adults have diabetes globally. Diabetes is responsible for 11% of deaths per year. Type 2 diabetes is the most common type of diabetes, accounting for 90-95% of cases. Type 2 diabetes is a metabolic disorder that is characterized by insulin resistance and results in hyperglycemia (high blood glucose

oteseconazole Treatment for Vaginal Candidiasis Mycovia Pharmaceuticals Announces U.S. FDA Acceptance and Priority Review of New Drug Application for Oteseconazole for the Treatment of Recurrent Vulvovaginal Candidiasis  DURHAM, N.C.–(BUSINESS WIRE) July 28, 2021 –Mycovia Pharmaceuticals, Inc. (Mycovia), an emerging biopharmaceutical company dedicated to recognizing and empowering those living with unmet medical needs by developing novel

FDA Approves Twyneo (tretinoin and benzoyl peroxide) for the Treatment of Acne Vulgaris NESS ZIONA, Israel, July 27, 2021 (GLOBE NEWSWIRE) — Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases, today announced that the Food and Drug

sulopenem Treatment for Bacterial Infection Iterum Therapeutics Receives Complete Response Letter from U.S. Food and Drug Administration for Oral Sulopenem DUBLIN, Ireland and CHICAGO, July 26, 2021 (GLOBE NEWSWIRE) — Iterum Therapeutics plc (Nasdaq: ITRM) (the “Company”), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by

New research investigates whether the mRNA from the COVID-19 vaccines can be passed on to infants through breastmilk. The development and administration of SARS-CoV-2 vaccines is helping to reduce transmission of COVID-19, and these vaccines have been an integral part of combating the global COVID-19 pandemic.  The first approved SARS-CoV-2 vaccines were mRNA vaccines, which

NORTH CHICAGO, Ill., July 23, 2021 /PRNewswire/ — AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) approved Dalvance® (dalbavancin) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients from birth. Dalvance is the first single-dose option administered as a 30-minute intravenous (IV) infusion for

News FDA Alerts HIS Issues Voluntary Nationwide Recall of Miss Slim Due to the Presence of Undeclared Sibutramine July 22, 2021 Audience: Consumer July 22, 2021 — Palisades Park, NJ, HIS is voluntarily recalling all lots and all presentations of Miss Slim (10 count & 30 count capsules) to the consumer level. HIS decided to

Vaccine uptake has varied worldwide, with some countries still experiencing higher rates of first COVID-19 vaccine dose compared with a second dose, suggesting some people may be skipping their second dose of the COVID-19 vaccine. A recent study suggests why this might not be a good choice. Conventionally, the approval of new vaccines worldwide has

tenapanor Treatment for Hyperphosphatemia of Renal Failure Ardelyx Provides Regulatory Update on New Drug Application for Tenapanor for the Control of Serum Phosphorus in Adult Patients with CKD on Dialysis FREMONT, Calif. and WALTHAM, Mass., July 19, 2021 /PRNewswire/ – Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company focused on the discovery, development, and commercialization of innovative first-in-class medicines to improve treatment

Treatment for Seizure Clusters Aquestive Therapeutics Resubmits New Drug Application for Libervant (diazepam) Buccal Film WARREN, N.J., June 24, 2021 (GLOBE NEWSWIRE) — Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, announced today the resubmission of its New Drug

July 19, 2021 — The US Food and Drug Administration (FDA) has approved fexinidazole as the first all-oral treatment for both stages of the Trypanosoma brucei gambiense form of sleeping sickness (Human African trypanosomiasis) in patients 6 years of age and older and weighing at least 20 kg.Fexinidazole was developed as part of an innovative

July 19, 2021 Audience: Consumer Tucson, AZ, Alpha Male Plus is voluntarily recalling all lots within expiry of Alpha Male Plus Male Enhancer fruit chews to the consumer level. FDA analysis has found the product to be tainted with tadalafil, an ingredient known as a phosphodiesterase (PDE-5) inhibitor found in a FDA approved product for

teplizumab Treatment for Prevention of Type 1 Diabetes Provention Bio Receives Complete Response Letter (CRL) to Biologics License Application (BLA) for Teplizumab for the Delay of Clinical Type 1 Diabetes (T1D) in At-Risk Individuals RED BANK, N.J., July 6, 2021 /PRNewswire/ – Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today

PARAMUS, N.J.–(BUSINESS WIRE) July 20, 2021 –The U.S. Food and Drug Administration (FDA) has granted approval to Octapharma USA for Octagam® 10% [Immune Globulin Intravenous (Human)], the first and only intravenous immunoglobulin (IVIg) to be indicated for the treatment of adult dermatomyositis, a rare immune-mediated inflammatory disease. The FDA approval is based on the results

July 20, 2021 Audience:  Patient, Health Professional, Pharmacy  What safety information is FDA announcing? The U.S. Food and Drug Administration (FDA) is requesting removal of its strongest warning against using cholesterol-lowering statin medicines in pregnant patients. Despite the change, most patients should stop statins once they learn they are pregnant. We have conducted a comprehensive

Treatment for Seizure Clusters Aquestive Therapeutics Announces FDA Acceptance of New Drug Application (NDA) Resubmission for Libervant (diazepam) Buccal Film WARREN, N.J., July 19, 2021 (GLOBE NEWSWIRE) — Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, announced today that

A promising malaria vaccine is being developed based on mRNA technology. Malaria is an infectious, life-threatening disease that is spread by mosquitoes. It is a global health threat: there were 228,000,000 clinical cases of malaria and 405,000 deaths worldwide in 2018. People who are at the highest risk of severe disease include pregnant women, children,

FDA Approves Bylvay (odevixibat) for the Treatment of Pruritus in Patients with Progressive Familial Intrahepatic Cholestasis (PFIC) BOSTON, July 20, 2021 (GLOBE NEWSWIRE) – Albireo Pharma, Inc. (Nasdaq: ALBO), a rare liver disease company developing novel bile acid modulators, today announced U.S. Food & Drug Administration (FDA) approval of Bylvay (odevixibat), the first drug approved for the treatment of pruritus in

July 19, 2021 Audience: Consumer July 19, 2021 — Pfizer is voluntarily recalling two lots of Chantix 0.5mg Tablets, two lots of Chantix 1 mg Tablets, and eight lots of a Chantix kit of 0.5mg/1 mg Tablets to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, above the Pfizer established Acceptable

Evidence from a recent study suggests that a specific gene may provide some resistance to severe symptoms of COVID-19. According to the study, the genetic make-up of those who experience severe COVID-19 symptoms, versus those who are asymptomatic, significantly differ at one gene location. The study found a significantly higher frequency of the HLA-DRB1*04:01 gene