Tuesday, April 7, 2020

Tuesday, April 7, 2020

Latest News

FDA: Coronavirus (COVID-19) Update: FDA Issues Diagnostic Emergency Use Authorization to Hologic and LabCorp

U.S. Food and Drug Administration took two additional significant diagnostic actions during the coronavirus outbreak (COVID-19) by issuing Emergency Use Authorizations (EUAs) to: Hologic for its Panther Fusion SARS-COV-2 Assay, and Laboratory Corporation of America (LabCorp) for its COVID-19 RT-PCR test.

FDA: Approves First Treatment for Group of Progressive Interstitial Lung Diseases

The U.S. Food and Drug Administration today approved Ofev (nintedanib) oral capsules to treat patients with chronic fibrosing (scarring) interstitial lung diseases (ILD) with a progressive phenotype (trait).

FDA: Approves New Treatment for Adults with Cushing’s Disease

Cushing’s disease is a rare disease in which the adrenal glands make too much of the cortisol hormone.

LUYE PHARMA: NDA Filing for Luye Pharma's Antidepressant Drug LY03005 Accepted by the U.S. FDA

Luye Pharma Group has announced that the U.S. Food and Drug Administration (FDA) has reviewed and accepted the filing of a New Drug Application (NDA) for LY03005, a new chemical drug for the treatment of major depressive disorder.

DEBIOPHARM: FDA Grants Breakthrough Therapy Designation for Debiopharm's Novel Chemo-Radio Sensitizer Debio 1143 for Front-line Treatment of Head & Neck Cancer

The FDA decision was based on the compelling magnitude of the clinically phase II findings in combination with chemo-radiotherapy presented in September 2019 at the ESMO congress (European Society for Medical Oncology)

BIOHAVEN PHARMACEUTICAL: Biohaven's NURTEC™ ODT (rimegepant) Receives FDA Approval for the Acute Treatment of Migraine in Adults

First and only calcitonin gene-related peptide (CGRP) receptor antagonist available in a fast-acting orally disintegrating tablet (ODT)

CMP PHARMA: First FDA approved Potassium Phosphates Injection from CMP Pharma Has Been Approved

First Ever FDA Approved Potassium Phosphates Injection Expected to Address Previous Market Shortages and Provide Improved Safety Profile as Opposed to Using Unapproved Products

ASTEX PHARMACEUTICALS: Announces U.S. Food and Drug Administration (FDA) Acceptance for Review of an NDA for the Combination Oral Hypomethylating Agent Cedazuridine and Decitabine (ASTX727 or oral C-DEC), for the Treatment of MDS and CMML

Astex Pharmaceuticals, Inc., a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., based in Japan, announced that the U.S. FDA has accepted for Priority Review its NDA for oral C-DEC (cedazuridine and decitabine) as a treatment for adults with previously untreated intermediate- and high-risk MDS including CMML.

PLASMOLOGY4: FDA Grants Plasmology4® "Breakthrough Device Designation" for the Treatment of Multidrug-Refractory Bacteria

Plasmology4®, Inc., a leader in Plasma Medicine, announced that the company's product has been granted into the U.S. Food and Drug Administration's (FDA) Breakthrough Devices Program for the treatment of "multidrug-refractory bacterial and/or fungal pathogen bioburden in a wound bed."

KLEO PHARMACEUTICALS: Receives IND Authorization to Proceed from FDA for its Multiple Myeloma Therapeutic

KP1237, a CD38-Targeting Antibody Recruiting Molecule (ARM™), to Be Tested in Combination with NK Cells to Treat Post-Transplant Multiple Myeloma Patients

PHARMACOSMOS THERAPEUTICS INC.: Monoferric® (ferric derisomaltose) injection is approved by the US FDA for the treatment of iron deficiency anemia

Pharmacosmos Therapeutics Inc. is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved Monoferric® (ferric derisomaltose) injection 100 mg/mL. Monoferric® is an intravenous iron indicated for the treatment of iron deficiency anemia (IDA) in adult patients who have an intolerance to oral iron or have had unsatisfactory response to oral iron, or who have non-hemodialysis dependent chronic kidney disease.

ARREVUS: Receives FDA Qualified Infectious Disease Product (QIDP) Designation for the Treatment of Cystic Fibrosis Pulmonary Exacerbations

Arrevus today announced the U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) Designation for ARV-1801 (sodium fusidate tablet) for the treatment of Cystic Fibrosis Pulmonary Exacerbations.

TEVA: Announces FDA Approval of AJOVY® (fremanezumab-vfrm) Injection Autoinjector

Teva Pharmaceuticals USA, Inc. an affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the Food and Drug Administration (FDA) has approved an autoinjector device for AJOVY® (fremanezumab-vfrm) injection.

U.S. FDA: FDA approves first treatment option specifically for patients with epithelioid sarcoma, a rare soft tissue cancer

U.S. Food and Drug Administration granted accelerated approval to Tazverik (tazemetostat) for the treatment of adults and pediatric patients aged 16 years and older with metastatic (when cancer cells spread to other parts of the body) or locally advanced (when cancer has grown outside the organ it started in, but has not yet spread to distant parts of the body) epithelioid sarcoma not eligible for complete resection (surgically removing all of a tissue, structure, or organ).

TENNOR THERAPEUTICS: Received FDA Orphan Drug Designation

TenNor Therapeutics, a clinical-stage, global biopharmaceutical company has received FDA Orphan Drug Designation for TNP-2092 to treat prosthetic joint infections.

MERCK: LYNPARZA® (olaparib) Approved by FDA as First-Line Maintenance Treatment of Germline BRCA-Mutated Metastatic Pancreatic Cancer

LYNPARZA Reduced the Risk of Disease Progression or Death by 47% Compared to Placebo in Patients Whose Disease Had Not Progressed On at Least 16 Weeks of a First-Line Platinum-Based Chemotherapy Regimen. Only PARP Inhibitor Approved in Germline BRCA-mutated Advanced Pancreatic Cancer

FDA Health News