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NEXUS PHARMACEUTICALS, INC.: Announces Launch of Emerphed™ (ephedrine sulfate) RTU Injection, the First and Only FDA-approved, Ready-to-Use Ephedrine Injection (50 mg/10 mL vial)

Nexus Pharmaceuticals, Inc. issued the following announcement on June 26.Nexus Pharmaceuticals announced that it has launched its patent-pending New Drug Application (NDA) Emerphed, the first and only premixed ephedrine in a ready-to-use 50 mg/10 mL vial.

FDA: Approves New Therapy for Dravet Syndrome

The U.S. Food and Drug Administration approved Fintepla (fenfluramine), a Schedule IV controlled substance, for the treatment of seizures associated with Dravet syndrome in patients age 2 and older.

FUSION HEALTHCARE SOLUTIONS: FUSION PPE Offers NIOSH and CDC Approved N95 Respirator Mask Produced by BYD

FUSION PPE Offers NIOSH and CDC Approved N95 Respirator Mask Produced by BYD, Backed by Warren Buffet, As Covid-19 Surges with Potential Second Wave, and FDA Reissues Emergency Use Authorizations (EUAs) Revising Which Respirators Can Be Decontaminated for Reuse

ZOGENIX, INC.: FDA Approves FINTEPLA® (fenfluramine) for the Treatment of Seizures Associated with Dravet Syndrome

FINTEPLA® significantly and substantially reduced convulsive seizure frequency in patients whose seizures were not adequately controlled on other medications, as observed in two phase 3 placebo-controlled clinical trials

FDA: Approves First Therapy for Rare Disease that Causes Low Phosphate Blood Levels, Bone Softening

The U.S. Food and Drug Administration approved Crysvita (burosumab-twza) injection to treat patients age two and older with tumor-induced osteomalacia (TIO), a rare disease that is characterized by the development of tumors that cause weakened and softened bones. The tumors associated with TIO release a peptide hormone-like substance known as fibroblast growth factor 23 (FGF23) that lowers phosphate levels.

ALMIRALL: Announces FDA Approval Of Updated Label For Seysara® (Sarecycline) Tablets

Seysara® is a novel oral antibiotic developed specifically for the treatment of acne

FDA: Approves First Treatment for Adult Onset Still’s Disease, a Severe and Rare Disease

The U.S. Food and Drug Administration approved Ilaris (canakinumab) injection for the treatment of Active Still’s disease, including Adult-Onset Still’s Disease (AOSD). Ilaris was previously approved for Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 years and older.

GENEQUANTUM HEALTHCARE: World's first iLDC enabling ADC drug receives IND clearance by the US FDA

GeneQuantum Healthcare (GQ) has recently received the US IND approval for its in-house developed next generation antibody drug conjugate (ADC) asset, GQ1001.

MYLAN N.V.: Mylan and Biocon Announce U.S. FDA Approval of Semglee™ (insulin glargine injection)

FDA approval marks a significant milestone to help increase access and affordability of insulin for the millions of Americans living with diabetes

MOLECULE HOLDINGS: Secures Distribution for FDA/EUA Approved COVID-19 Rapid Antibody Tests

In the initial scramble to quell the impact of the COVID-19 pandemic, the rapid antibody test market was been flooded. Not all tests are created equal and the COVID-19 crisis introduced the opportunity to try unproven players in rapid diagnostic testing.

PHOSPHORUS: Announces FDA Approval Of At-Home Saliva Test For COVID-19

Tests Facilitate Safe Clinical Care and Employer Health Programs, Also Available to General Public Through Web Order

ABIOMED: FDA Approves Abiomed’s First-in-Human Trial of Impella ECP, World’s Smallest Heart Pump

The US FDA has approved Abiomed’s first-in-human trial of the Impella ECP, a temporary percutaneous heart pump that expands once inside the body, allowing for a smaller access site. Read more about the ECP and Abiomed’s early feasibility study.

NOCTRIX HEALTH: Granted FDA Breakthrough Device Designation for wearable Restless Legs Syndrome Therapy

Noctrix Health, Inc., a privately held medical device company announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its wearable NTX100 Neuromodulation therapy designed for the treatment of adults with primary moderate-severe Restless Legs Syndrome (RLS) who are refractory to medications.

FDA Health News