FDA chief's convoy ambushed in Camarines Sur

FDA chief's convoy ambushed in Camarines Sur

(UPDATED) At least 3 cops are killed and 3 others wounded, while Food and Drug Administration chief Nela Charade Puno is unharmed, police say Published 12:40 PM, October 18, 2018 Updated 1:45 PM, October 18, 2018 CRIME SCENE. The tailing police vehicle accompanying the convoy of Food and Drug Administration chief Nela Charade Puno is […]

FDA-Approved Skin Care Drug Found to Reverse Severe Hair Loss

FDA-Approved Skin Care Drug Found to Reverse Severe Hair Loss

A popular skin care drug—which is intended to target eczema—was just found to have an unusual side effect: hair growth. According to an article on Newsweek, the FDA-approved drug dupilumab was given to a 13-year-old alopecia sufferer to treat her eczema. The patient, who hadn’t grown hair on her scalp since she was two, suddenly […]

FDA's Drug Centers Release New Draft Guidance on Quantitative Info in Consumer-Directed Ads

FDA's Drug Centers Release New Draft Guidance on Quantitative Info in Consumer-Directed Ads

Wednesday, October 17, 2018 In the first new guidance document from FDA in several years specific to the subject of direct-to-consumer (DTC) promotion of prescription drugs and biological products, the Agency is recommending that companies take additional steps to ensure that quantitative efficacy or risk information does not convey inaccurate information and does not have […]

FDA clears Pfizer PARP drug, Myriad companion test for breast cancer

FDA clears Pfizer PARP drug, Myriad companion test for breast cancer

Brief Dive Brief: FDA approved Pfizer’s poly ADP ribose polymerase (PARP) inhibitor Talzenna (talazoparib) in conjunction with Myriad Genetics’ companion diagnostic for patients with HER2-negative, locally advanced or metastatic breast cancer who have an inherited BRCA mutation. Patients must be selected for treatment based on Myriad’s BRACAnalysis CDx test to identify breast cancer patients eligible […]

FDA Approves Pfizer's Talzenna for Breast Cancer

FDA Approves Pfizer's Talzenna for Breast Cancer

The U.S. Food and Drug Administration (FDA) approved Pfizer’s PARP inhibitor, Talzenna (talazoparib), for patients with a germline BRCA-mutated (gBRCAm), HER2-negative breast cancer. The agency also approved Myriad Genetics’ diagnostic assay to identify the mutation. The approval was built on the EMBRACA clinical trial, an open-label study that randomized 431 patients on a two-to-one ratio with […]

FDA Releases Draft Guidances to Promote Clinical Trial Design Efficiency

FDA Releases Draft Guidances to Promote Clinical Trial Design Efficiency

Wednesday, October 17, 2018 On September 28, 2018, the U.S. Food and Drug Administration (FDA) released two draft guidances for industry. The purpose, according to FDA Commissioner Scott Gottlieb, M.D., is to modernize the approach to clinical trial design in efforts to (1) make clinical trials more efficient while maintaining patient safety and (2) increase the […]

Olaparib Granted Orphan Drug Designation by FDA for Pancreatic Cancer

Olaparib Granted Orphan Drug Designation by FDA for Pancreatic Cancer

Roy Baynes, MD, PhD Olaparib (Lynparza) has been granted an orphan drug designation by the FDA for the treatment of patients with pancreatic cancer, AstraZeneca and Merck, the developers of the PARP inhibitor, have announced.1 The ongoing, randomized, multicenter, double-blind, placebo-controlled phase III POLO trial (NCT02184195) is currently evaluating olaparib as maintenance therapy in patients with germline […]

Axsome Therapeutics (AXSM) Announces FDA Orphan Drug Designation for AXS-12 for the Treatment of Narcolepsy

Axsome Therapeutics (AXSM) Announces FDA Orphan Drug Designation for AXS-12 for the Treatment of Narcolepsy

Get instant alerts when news breaks on your stocks. Claim your 2-week free trial to StreetInsider Premium here. Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, received on Tuesday, October 16, Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) […]

FDA Warning Wire: E-Cig Juice Spiked With ED Drugs

FDA Warning Wire: E-Cig Juice Spiked With ED Drugs

By Emily Field Law360 (October 16, 2018, 8:06 PM EDT) — An e-cigarette company’s vaping liquid was packing more than nicotine with the addition of the active ingredients in erectile dysfunction drugs, a first according to the U.S. Food and Drug Administration…. To view the full article, register now. Source link