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FDA Approves mRESVIA (respiratory syncytial virus vaccine) for Prevention of Lower Respiratory Tract Disease Caused by RSV
CAMBRIDGE, MA / ACCESSWIRE / May 31, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved mRESVIA...
FDA Approves Onyda XR (clonidine hydrochloride) Non-Stimulant Liquid Treatment for ADHD
May 29, 2024 – Business Wire – Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on attention deficit hyperactivity...
U.S. Food and Drug Administration Approves Bristol Myers Squibb’s Breyanzi as a New CAR T Cell Therapy for Relapsed or Refractory Mantle Cell Lymphoma
(BUSINESS WIRE) May 30, 2024 -- Bristol Myers Squibb (NYSE: BMY) today announced the U.S. Food and Drug Administration (FDA) has granted approval for...
FDA Grants Accelerated Approval to Retevmo (selpercatinib) for Pediatric Patients Two Years and Older with RET-Altered Metastatic Thyroid Cancer or Solid Tumors
On May 29, 2024, the Food and Drug Administration granted accelerated approval to selpercatinib (Retevmo, Eli Lilly and Company) for pediatric patients...
FDA Approves Bkemv (eculizumab-aeeb), an Interchangeable Biosimilar to Soliris
Today, the U.S. Food and Drug Administration approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) to treat...
9.6 Percent of Medical Visits Took Place Via Telehealth in 2021
In 2021, 9.6 percent of medical visits took place via telehealth, with a higher percentage seen for mental health visits, according to a research letter...
FDA Approves First Liquid, Nonstimulant ADHD Treatment, Onyda XR
The U.S. Food and Drug Administration has approved once-daily Onyda XR (clonidine hydrochloride) as the first liquid, nonstimulant treatment for attention-deficit/hyperactivity...
First-Line Biparametric MRI Less Cost-Effective Than PSA for Prostate Cancer Screening
From an economic perspective, first-line prostate-specific antigen (PSA) testing is favored over biparametric magnetic resonance imaging (bpMRI) for prostate...
32 Percent of U.S. Adults Know Someone Who Died of a Drug Overdose
Thirty-two percent of U.S. adults report knowing someone who died of a drug overdose, according to a study published online May 31 in JAMA Health Forum. Alene...
FDA Warns of Bacterial and Other Dangers From Recalled Infant Formula
The U.S. Food and Drug Administration is warning parents about a goat milk infant formula potentially tainted with a bacterium that's very dangerous to...
U.S. Will Make Millions of Bird Flu Vaccines This Summer
As the H5N1 avian flu continues to spread among dairy cows in the United States, nearly 5 million doses of flu vaccine are now being prepared for possible...
Male Birth Control Gel Shows Promise in Trial
A new hormonal gel could one day be a potential form of birth control for men, researchers reported Sunday. “The development of a safe, highly effective...
Lack of Insurance Keeps Many Americans From Best Cancer Meds
A cutting-edge class of drugs is saving and extending the lives of cancer patients. But the drugs, called immune checkpoint inhibitors (ICIs), are so...
Avirmax Biopharma Inc. Receives IND Approval for Phase I/IIa Trial to Treat Wet AMD including PCV
HAYWARD, Calif., May 30, 2024. Avirmax Biopharma, Inc., a leading innovator in genetic medicines, is pleased to announce that it has received Investigational...
Novartis Phase III Data Confirm Sustained Efficacy and Long-Term Safety of Oral Remibrutinib in Chronic Spontaneous Urticaria
Basel, May 31, 2024 – Novartis today announced new data that confirm the long-term efficacy and safety of remibrutinib, a highly selective Bruton’s...
Monthly News Roundup - May 2024
FDA Clears GSK’s Benlysta Autoinjector for Systemic Lupus Erythematosus (SLE) in Children In May, the U.S Food and Drug Administration (FDA) cleared...
U.S. FDA Acknowledges Astellas' Resubmission of Biologics License Application for Zolbetuximab and Sets New Action Date
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the U.S. Food and Drug Administration (FDA) has acknowledged...
Could Tattoos Be Linked to Blood Cancer Risk?
Research suggests that tattoo ink spurs inflammatory changes that might contribute to the development of lymphoma. The findings are early, however, and...
Sagent Pharmaceuticals Issues Voluntary Nationwide Recall of Docetaxel Injection, USP Due to Potential Presence of Particulate Matter
SCHAUMBURG, IL – May 28, 2024 – Sagent Pharmaceuticals today announced the voluntary nationwide recall of two lots of Docetaxel Injection,...
Recently Added
Recently added consumer and prescribing information: mRESVIA, Bkemv, Yesafili, Myhibbin, Rezenopy, Libervant, Beqvez, Xolremdi, Pivya, Xromi
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Latest FDA New Drug Approvals
- mRESVIA mRESVIA (respiratory syncytial virus vaccine, mRNA) is an mRNA respiratory syncytial virus (RSV) vaccine indicated to protect adults aged...
- Onyda XR Onyda XR is a once-daily extended-release oral suspension of clonidine hydrochloride for the treatment of attention-deficit/hyperactivity...
- Bkemv Bkemv (eculizumab-aeeb) is a complement inhibitor interchangeable biosimilar to Soliris for the treatment of paroxysmal nocturnal...
Drugs in Development (Not yet approved)
- Yutrepia Yutrepia (treprostinil) is an inhaled dry powder formulation of treprostinil for the treatment of pulmonary arterial hypertension (PAH) to...