FDA Approves Talvey (talquetamab-tgvs), a First-in-Class Bispecific Therapy for the Treatment of Patients with Heavily Pretreated Multiple Myeloma
HORSHAM, Pa., Aug. 10, 2023– The Janssen Pharmaceutical Companies of Johnson& Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Talvey™ (talquetamab-tgvs), a first-in-class... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 10, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Grants Regular Approval for Gavreto (pralsetinib) for Non-Small Cell Lung Cancer with RET Gene Fusions
On August 9, 2023, the Food and Drug Administration granted regular approval to pralsetinib (Gavreto, Genentech, Inc.) for adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 9, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Izervay (avacincaptad pegol) Intravitreal Solution for the Treatment for Geographic Atrophy
TOKYO, Aug. 5, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, " Astellas " ), today announced the U.S. Food and Drug Administration (FDA) approved Izervay™ (avacincaptad pegol intravitreal solution) for... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 5, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Zurzuvae (zuranolone) First Oral Treatment for Postpartum Depression
August 04, 2023 -- Today, the U.S. Food and Drug Administration approved Zurzuvae (zuranolone), the first oral medication indicated to treat postpartum depression (PPD) in adults. PPD is a major depressive episode that typically occurs after... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 4, 2023 Category: Drugs & Pharmacology Source Type: news
U.S. FDA Approves Merck ’s Ervebo (Ebola Zaire Vaccine, Live) for Use in Children 12 Months of Age and Older
RAHWAY, N.J.--(BUSINESS WIRE) August 3, 2023 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Ervebo, which is now... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 3, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Lonsurf (trifluridine/tipiracil) in Combination With Bevacizumab for Adult Patients With Metastatic Colorectal Cancer (mCRC)
Approval clinical trial showing that treatment with Lonsurf plus bevacizumab resulted in statistically significant and clinically meaningful improvements in overall survival in patients with previously treated mCRC compared to Lonsurf as a single... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 2, 2023 Category: Drugs & Pharmacology Source Type: news
Jemperli (dostarlimab-gxly) Plus Chemotherapy Approved in the US for dMMR/MSI-H Primary Advanced or Recurrent Endometrial Cancer
Jemperli is the only immuno-oncology treatment approved in the frontline setting for this patient population in combination with chemotherapy
Patients with this type of endometrial cancer face significant unmet need and typically experience poor... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 31, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves RiVive (naloxone hydrochloride) Over-the-Counter Nasal Spray for the Emergency Treatment of Opioid Overdose
Pittsburgh, Pennsylvania--(Newsfile Corp. - July 28, 2023) - Harm Reduction Therapeutics (HRT), Inc., a nonprofit pharmaceutical company, announced today that FDA has approved OTC RiVive™ (naloxone HCl nasal spray 3 mg) for the emergency... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 28, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Balfaxar (prothrombin complex concentrate, human-lans) for Warfarin Reversal in Urgent Surgery & Invasive Procedures
PARAMUS, N.J., July 26, 2023 /PRNewswire/ -- Octapharma USA today announced that Balfaxar® (prothrombin complex concentrate, human-lans; marketed in Europe and Canada as octaplex®) has received U.S. Food and Drug Administration (FDA)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 26, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Xdemvy (lotilaner) Ophthalmic Solution for the Treatment of Demodex Blepharitis
IRVINE, Calif., July 25, 2023 (GLOBE NEWSWIRE) -- Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), whose mission is to focus on unmet needs and apply proven science and new technology to revolutionize treatment for patients, starting with eye care,... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 25, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Ycanth (cantharidin) Topical Solution for the Treatment of Molluscum Contagiosum
WEST CHESTER, PA–Jul 21, 2023 (GLOBE NEWSWIRE)– Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 21, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Vanflyta (quizartinib) for Patients with Newly Diagnosed FLT3-ITD Positive Acute Myeloid Leukemia
TOKYO& BASKING RIDGE, N.J. July 20, 2023 --(BUSINESS WIRE)--Daiichi Sankyo (TSE: 4568) today announced that Vanflyta (quizartinib) has been approved by the U.S. Food and Drug Administration (FDA) in combination with standard cytarabine and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 20, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Cyfendus (Anthrax Vaccine Adsorbed, Adjuvanted) Two-Dose Anthrax Vaccine for Post-Exposure Prophylaxis Use
GAITHERSBURG, Md., July 20, 2023 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) announced today that the U.S. Food and Drug Administration (FDA) has approved Cyfendus (Anthrax Vaccine Adsorbed, Adjuvanted), previously known as AV7909, for... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 20, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Beyfortus (nirsevimab) for the Prevention of RSV Lower Respiratory Tract Disease in Infants
July 17, 2023 -- AstraZeneca and Sanofi’s Beyfortus (nirsevimab) has been approved in the US for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants born during or entering their... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 17, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Veklury (remdesivir) for COVID-19 Treatment in Patients With Severe Renal Impairment, Including Those on Dialysis
FOSTER CITY, Calif.--(BUSINESS WIRE) July 14, 2023 -- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application (sNDA) for the use of Veklury® (remdesivir)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 14, 2023 Category: Drugs & Pharmacology Source Type: news
