Approvals Archives - Page 29 of 38

J&J’s nasal spray antidepressant wins U.S. approval

Anesthetics, Approvals, Boxed Warning, Elevated Blood Pressure, FDA, FDA/Regulatory, Major Depressive Disorder (MDD), Nasal Sprays, Potential Blockbusters, Treatment-Resistant Depression

The U.S. FDA approved Johnson & Johnson’s nasal spray antidepressant Spravato for people resistant to other treatments, but placed restrictions on use of the drug.

March 5, 2019/by Reuters Health

FDA Approves Bausch + Lomb’s Lotemax SM 0.38%

Approvals, FDA, FDA/Regulatory, Gels, Ocular Surgery, Ocular Tissues, Ophthalmics, Postoperative inflammation

The U.S. FDA approved Bausch + Lomb’s Lotemax SM (loteprednol etabonate ophthalmic gel) 0.38%, a new gel formulation for treating postoperative inflammation and pain following ocular surgery.

February 25, 2019/by PR Newswire

FDA approves Sanofi’s Cablivi for aTTP

Acquired Thrombotic Thrombocytopenic Purpura (aTTP), Approvals, Blood Disorders, FDA, FDA/Regulatory, Immunosuppression, Nanobodies, Von Willebrand Factor (VWF)

The U.S. FDA approved Cablivi in combination with plasma exchange and immunosuppression for treating acquired thrombotic thrombocytopenic purpura (aTTP) in adults.

February 6, 2019/by GlobeNewswire

FDA Clears First Diagnostic Test to Detect Emerging Health Threat Mycoplasma genitalium

Approvals, Diagnostics, FDA/Regulatory, Sexually Transmitted Infections (STIs)

Hologic Inc. announced that the U.S. Food and Drug Administration granted clearance for the company’s Aptima Mycoplasma genitalium assay, the first FDA-cleared test to detect this under-recognized but increasingly common sexually transmitted infection (STI).

January 23, 2019/by Business Wire

Abbott Offers a New Option for Physicians Treating Patients with Atrial Fibrillation

3D Mapping, Approvals, Atrial Fibrillation, Cardiac, Catheters, FDA, FDA/Regulatory, Health Technology, Heart, Heart tissue, Patients, Physicians

Abbott announced U.S. Food and Drug Administration approval of the TactiCath Contact Force Ablation Catheter, Sensor Enabled, a new ablation catheter designed to help physicians accurately and effectively treat atrial fibrillation (AFib).

January 21, 2019/by PR Newswire

FDA Approves Expanded Use of Adacel Vaccine for Repeat Vaccination

Approvals, Diphtheria, Expanded Use, FDA, FDA/Regulatory, pertussis, tetanus, Vaccines, Whooping Cough

The U.S. Food and Drug Administration approved the expanded use of Adacel to include repeat vaccination to help protect against tetanus, diphtheria and pertussis.

January 14, 2019/by PR Newswire

FDA Approves World’s First Device for Treatment of Premature Babies and Newborns with an Opening in Their Hearts

Approvals, Babies, FDA, FDA/Regulatory, Heart, Medical Devices, Newborns

Abbott announced the U.S. Food and Drug Administration approved the Amplatzer Piccolo Occluder, the world’s first medical device that can be implanted in the tiniest babies using a minimally invasive procedure to treat patent ductus arteriosus (PDA).

January 14, 2019/by PR Newswire

Sprycel Approved in Combination with Chemo in Certain Pediatric Patients with PH+ ALL

Acute Lymphoblastic Leukemia (ALL), Approvals, Biopharmaceutical, Chemotherapy, FDA, FDA/Regulatory, New Indications, Oncology, Pediatric, Priority Review, Tyrosine kinase inhibitors

Bristol-Myers Squibb Company announced the U.S. Food and Drug Administration expanded the indication for Sprycel tablets to include the treatment of pediatric patients 1 year of age and older with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) in combination with chemotherapy.

January 2, 2019/by Business Wire

FDA Approves Herceptin Biosimilar Herzuma

Approvals, Biosimilars, Blockbusters, Breast Cancer, FDA, FDA/Regulatory, HER2/neu receptor antagonists, Therapeutics

Celltrion Inc. and Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration approved Herzuma (trastuzumab-pkrb), a HER2/neu receptor antagonist biosimilar to Herceptin (trastuzumab).

December 14, 2018/by Business Wire

FDA Approves Aemcolo For Travelers’ Diarrhea

Antibiotics, Approvals, Bacteria, Clinical Data, E. Coli, FDA, FDA/Regulatory, Traveler's Diarrhea

The U.S. FDA approved Aries Pharmaceuticals Inc.’s Aemcolo (rifamycin) for the treatment of adult patients with Travelers’ Diarrhea caused by non-invasive strains of Escherichia coli.

November 19, 2018/by PR Newswire