Gilead's Veklury becomes first FDA-approved drug for COVID-19

Bio Pharma Dive

regulator granted a full approval after allowing emergency use earlier this year. The U.S. New results from an WHO study, however, raise questions about the drug's ultimate effectiveness

5 FDA approval decisions to watch in the 4th quarter

Bio Pharma Dive

The world's attention will be on the FDA as it considers initial data from coronavirus vaccine developers. But several other important drugs, including a CAR-T therapy and an Ebola antibody, will also be on the agency's agenda

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FDA approves Regeneron antibody drug as first Ebola virus treatment

Bio Pharma Dive

Research for the drug, now cleared as Inmazeb, helped Regeneron jumpstart its fast development of an antibody therapy for COVID-19

Janssen’s Simponi Aria Gains Extended FDA Approvals for Rare Children’s Arthritis Conditions

XTalks

The US Food and Drug Administration (FDA) has given approval to Janssen Pharmaceutical for Simponi Aria (golimumab) in the treatment of patients two years of age and older with active polyarticular juvenile idiopathic arthritis (pJIA).

FDA Approves NS Pharma’s Viltepso for Duchenne Muscular Dystrophy

BioSpace

Food and Drug Administration (FDA) approved another therapy for Duchenne muscular dystrophy (DMD), this time NS Pharma’s Viltepso (viltolarsen The U.S.

FDA Approves First Acne Treatment with New Mechanism of Action in 40 Years

BioSpace

Food and Drug Administration (FDA) approved Italy-based Cassiopea SpA’s acne treatment Winlevi (clascoterone cream 1 The U.S.

FDA approves first liquid biopsy test that uses advanced gene sequencing

Bio Pharma Dive

The test, developed by Guardant Health, combines next-generation sequencing with a cancer blood test

FDA Approves Veklury (remdesivir) for the Treatment of COVID-19

The Pharma Data

FDA Approves Veklury (remdesivir) for the Treatment of COVID-19. Food and Drug Administration (FDA) has approved the antiviral drug Veklury (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization.

Mission successful for Novartis after FDA approves ofatumumab in MS

Pharma Phorum

It’s mission accomplished for Novartis after the FDA approved ofatumumab for multiple sclerosis, completing a project where the former cancer drug has been repurposed. The FDA approved ofatumumab under the brand name Kesimpta for people living with relapsing forms of multiple sclerosis.

F.D.A. Approves Remdesivir as First Drug to Treat Covid-19

NY Times

The move indicated that the drug had cleared more rigorous hurdles since it was given emergency authorization in May

Roche wins FDA approval for 1st self-administered biologic for rare eye disease

Bio Pharma Dive

Enspryng is the second drug OK'd in three months for an autoimmune disorder that causes blindness and impaired mobility, but it's the only one that patients can take at home

 FDA Approves Genentech’s Enspryng for Neuromyelitis Optica Spectrum Disorder

BioTech 365

– First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks – – First and only approved therapy for NMOSD designed to target … Continue reading → Business Wire

FDA Approves Genentech’s Enspryng for Neuromyelitis Optica Spectrum Disorder

BioSpace

Food and Drug Administration approved Genentech’s Enspryng (satralizumab-mwge) as a subcutaneous treatment for adults with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder The U.S.

Genetech scores sixth FDA approval in lung cancer with Gavreto

The Pharma Data

Genentech’s once-daily oral therapy Gavreto (pralsetinib) has secured FDA backing in the treatment of metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC), it has emerged.

Janssen’s depression nasal spray Spravato bags new FDA approval

The Pharma Data

Drug approved to treat major depressive disorder with acute suicidal ideation or behaviour.

FDA approves GlaxoSmithKline’s Nucala to treat hypereosinophilic syndrome

The Pharma Data

The FDA has announced its approval of GlaxoSmithKline’s Nucala (mepolizumab) as a treatment for hypereosinophilic syndrome (HES). . This approval comes after GSK submitted results from its Phase 3 trial which enrolled 108 patients. Photo by Maxwell Hamilton.

Avioq Announces FDA Approval of VioOne™ HIV Profile™ Supplemental Assay

BioTech 365

announces it has received approval from the U.S. Food and Drug Administration (FDA) for their VioOne™ HIV Profile™ Supplemental Assay. RESEARCH TRIANGLE PARK, N.C.–(BUSINESS –(BUSINESS WIRE)–Avioq, Inc. The HIV Profile™ assay is an enzyme-linked immunosorbent assay (ELISA) for confirmation and differentiation … Continue reading → Business Wire

FoundationOne®CDx Receives FDA-Approval as a Companion Diagnostic for VITRAKVI®(larotrectinib) to Identify Patients with NTRK Fusions Across All Solid Tumors

BioTech 365

today announced that it has received approval from the U.S. CAMBRIDGE, Mass.–(BUSINESS –(BUSINESS WIRE)–Foundation Medicine, Inc.

Janssen’s depression nasal spray Spravato bags new FDA approval

Pharma Times

Drug approved to treat major depressive disorder with acute suicidal ideation or behaviour

ADDING MULTIMEDIA FDA Approves Genentech’s Enspryng for Neuromyelitis Optica Spectrum Disorder

BioTech 365

– First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks – – First and only approved therapy for NMOSD designed to target … Continue reading → Business Wire

FDA approves the guardian needle, a solution for reducing accidental needle sticks

Scienmag

Medical University of South Carolina clinician-innovators targeted the problem of needle-stick injuries during intraoperative monitoring; their invention, a safer needle, is now FDA approved and licensed to Rhythmlink for rollout this fall in hospitals Credit: Photograph by Joshua Aaron Photography, provided by Rhythmlink.

U.S. FDA Approves Pfizer’s XELJANZ® (tofacitinib) for the Treatment of Active Polyarticular Course Juvenile Idiopathic Arthritis

BioTech 365

Food and Drug Administration (FDA) approved XELJANZ® (tofacitinib) for the treatment of children and adolescents 2 years and older with active polyarticular course juvenile idiopathic arthritis (pcJIA). NEW YORK–(BUSINESS WIRE)–Pfizer Inc.

FDA approves GlaxoSmithKline’s Trelegy for treating asthma

The Pharma Data

Photo by the CDC/FDA. The FDA has approved a new indication of Trelegy Ellipta for the treatment of asthma and patients with chronic obstructive pulmonary disease. .

FDA approves GSK’s Blenrep for advanced multiple myeloma

Pharma Phorum

The FDA has approved GlaxoSmithKline’s multiple myeloma drug Blenrep, a first-in-class potential blockbuster that will be used in advanced disease. The post FDA approves GSK’s Blenrep for advanced multiple myeloma appeared first on.

FDA Approves New HIV-1/HIV-2 Qualitative Test from Roche

BioSpace

This test will give healthcare providers a single result to confirm an HIV diagnosis with patients and differentiate between HIV-1 and HIV-2

FDA approves Abbott’s rapid portable COVID-19 test

The Pharma Data

The FDA has given emergency clearance for Abbott’s portable COVID-19 test that it will sell for just $5. . The company’s BinaxNOW COVID-19 Ag Card test can give results within 15 minutes and is designed to be administered in places like schools and workplaces to carry out mass testing.

Roche takes on pricey rivals as FDA approves SMA drug

Pharma Phorum

Roche is hoping to undercut hugely expensive rivals after the FDA approved its oral spinal muscular atrophy (SMA) drug Evrysdi (risdiplam). The FDA approved Evrysdi for the treatment of spinal muscular atrophy (SMA) in adults and children two months of age and older.

FDA Approves Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) Antibody Cocktail for Ebola (Zaire Ebolavirus)

The Pharma Data

Food and Drug Administration (FDA) approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including newborns of mothers who have tested positive for the infection. TARRYTOWN, N.Y.,

FDA approves Phase 1 trial for HIV gene therapy

The Pharma Data

The FDA has approved a request from American Gene Technologies to begin a clinical study into its HIV gene therapy. Air Force photo by Kemberly Groue. It will investigate the safety, measure key biomarkers and assess surrogate markers of efficacy in its AGT103-T treatment.

Roche takes on Alexion as FDA approves satralizumab in NMOSD

Pharma Phorum

The FDA has approved Roche’s satralizumab for the rare autoimmune disorder Neuromyelitis Optica Spectrum Disorder (NMOSD), under the brand name Enspryng. This approval is supported by results from two randomised controlled phase 3 trials, the SAkuraStar and SAkuraSky studies.

FDA approves opioid Olinvyk for patients with acute pain

The Pharma Data

The FDA has approved Olinvyk for the management of moderate to severe pain in adult patients when their pain is severe enough to require an intravenous opioid or if alternative treatments do not work.

Roche announces FDA approval of FoundationOne Liquid CDx, a comprehensive pan-tumour liquid biopsy test

The Pharma Data

Food and Drug Administration (FDA) has approved FoundationOne®Liquid CDx, Foundation Medicine’s comprehensive pan-tumour liquid biopsy test for patients with solid tumours. The results are delivered in an integrated report that identifies alterations matched to FDA-approved therapies.

Nevakar Announces FDA Approval for Ephedrine Sulfate Injection as Ready-to-Use Vials

The Pharma Data

a biopharmaceutical company developing multiple assets in the ophthalmic and injectable areas, announced today it received approval from the U.S. Food and Drug Administration (FDA) to market Ephedrine Sulfate Injection in a ready-to-use 50mg/10 ml single use vial presentation. This is the first approval under the previously announced collaboration between Nevakar and Endo for the development of five differentiated, sterile injectable products in the U.S. BRIDGEWATER, N.J.,

Genentech Announces Full FDA Approval for Venclexta Combinations for Acute Myeloid Leukemia

BioTech 365

Simplify Medical Receives FDA Approval for 1-Level Simplify Disc PMA

BioTech 365

Simplify Disc overall success rate of 93.0% was superior to the ACDF control SUNNYVALE, Calif., 21, 2020 (GLOBE NEWSWIRE) — Simplify Medical, a privately-held company focused on cervical spinal disc arthroplasty and developer of the Simplify® cervical artificial disc, … Continue reading → GlobeNewswire

FDA Approves Roche’s ENSPRYNG for Neuromyelitis Optica Spectrum Disorder (NMOSD)

BioTech 365

First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks First and only approved therapy for NMOSD designed to target and inhibit interleukin-6 … Continue reading → GlobeNewswire

Eton Pharmaceuticals Announces FDA Approval of Orphan Drug ALKINDI® SPRINKLE (hydrocortisone) as Replacement Therapy in Pediatric Patients with Adrenocortical Insufficiency

BioTech 365

-ALKINDI SPRINKLE is the first and only FDA-approved granular hydrocortisone formulation for adrenocortical insufficiency specifically designed for children -Eton expects ALKINDI SPRINKLE to be available in the fourth quarter of 2020 DEER PARK, Ill.,

Regeneron’s Inmazeb becomes the first FDA-approved treatment for Ebola

BioPharma Reporter

Food and Drug Administration (FDA) has approved Regeneronâs Inmazeb for treatment of Ebola. The U.S. The antibody cocktail was developed using the same ârapid responseâ technologies as Regeneronâs investigational COVID-19 antibody combination. Bio Developments

FDA approves BMS’ Opdivo and Yervoy combination in first-line mesothelioma

Pharma Phorum

Bristol-Myers Squibb’s immunotherapy combination of Opdivo and Yervoy has been approved in the US in a new indication for untreated mesothelioma, a rare but aggressive form of cancer that forms in the lining of the lungs.

NS Pharma takes on Sarepta as FDA approves DMD drug

Pharma Phorum

The FDA has approved a new therapy for the rare muscle wasting disease Duchenne muscular dystrophy (DMD) as Japan’s NS Pharma takes on Sarepta and its controversially approved rival. The post NS Pharma takes on Sarepta as FDA approves DMD drug appeared first on.