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FDA: Approves First Generic of a Commonly Used Albuterol Inhaler to Treat and Prevent Bronchospasm

The U.S. Food and Drug Administration approved the first generic of Proventil HFA (albuterol sulfate) Metered Dose Inhaler, 90 mcg/Inhalation, for the treatment or prevention of bronchospasm in patients four years of age and older who have reversible obstructive airway disease, as well as the prevention of exercise-induced bronchospasm in this age group.

POLARYX THERAPEUTICS: Receives IND Approval From the FDA to Study PLX-200 Treatment for Patients With Juvenile Neuronal Ceroid Lipofuscinosis

Polaryx Therapeutics, a biotech company developing patient-friendly, small molecule therapeutics for lysosomal storage disorders, announced today that the Company has received an Investigational New Drug Application (IND) approval from the U.S. Food and Drug Administration (FDA) to study PLX-200 treatment on Juvenile Neuronal Ceroid Lipofuscinosis (JNCL or CLN3) patients.

AMPIO PHARMACEUTICALS, INC.: Ampio is Preparing an Expanded Access FDA protocol to Study Nebulized Ampion as a Treatment for Moderate to Severe Acute Respiratory Distress Syndrome Associated with COVID-19

Ampio Pharmaceuticals, Inc. issued the following announcement on March 24.Ampio Pharmaceuticals, Inc. (NYSE American: AMPE), a pre-revenue development stage biopharmaceutical company focused on the development of immunology based therapies to treat prevalent inflammatory conditions for which limited treatment options exist, announced today that it is preparing an expanded access FDA protocol to study potential benefit of nebulized treatment with Ampion in SARS-Cov-2 ("COVID-19") induced Acute Respiratory Distress Syndrome ("ARDS"), an immediately life-threatening condition.Ampio's Scientific Advisory Board ("SAB") members David Bar-Or, MD, Pablo Rubinstein, MD, and Edward Brody, MD, PhD, determined after a careful review of the published articles on the properties of Ampion, that nebulized Ampion may be suitable to treat another inflammatory indication.

FDA: Coronavirus (COVID-19) Update: FDA allows expanded use of devices to monitor patients’ vital signs remotely

U.S. Food and Drug Administration’s ongoing efforts to address the coronavirus outbreak (COVID-19), the agency issued a new policy that allows manufacturers of certain FDA-cleared non-invasive, vital sign-measuring devices to expand their use so that health care providers can use them to monitor patients remotely.

JANSSEN ONCOLOGY: Janssen Announces Submission to U.S. FDA for New DARZALEX® (Daratumumab)-Based Combination Regimen for Patients with Relapsed/Refractory Multiple Myeloma

Application is based on positive data from the Phase 3 CANDOR study, which were presented at the 2019 American Society of Hematology Annual Meeting

TUBEROUS SCLEROSIS ALLIANCE: Lauds Lundbeck And FDA For Sabril Label Expansion For Patients 2 To 10 Years Old

On January 24, the Tuberous Sclerosis Alliance (TS Alliance) learned the US Food and Drug Administration (FDA) formally approved Lundbeck Pharmaceutical's label expansion for Sabril® (vigabatrin) to now be available to treat refractory complex partial seizures in patients 2 to 10 years old.

ABBOTT: Receives Expanded Indication From the U.S. FDA for Directional Deep Brain Stimulation System to Treat Parkinson's Disease

Abbott's Infinity™ DBS is the first FDA approved directional Deep Brain Stimulation (DBS) system to allow targeting of a specific area of the brain that is critical to motor functions

INHIBITOR THERAPEUTICS: Receives prostate cancer IND Clearance from FDA

SUBA™-Itraconazole to be Tested in Combination with Standard of Care Chemotherapy for Metastatic Castrate Resistant Prostate Cancer

U.S. FDA: FDA approves first treatment for thyroid eye disease

U.S. Food and Drug Administration (FDA) approved Tepezza (teprotumumab-trbw) for the treatment of adults with thyroid eye disease, a rare condition where the muscles and fatty tissues behind the eye become inflamed, causing the eyes to be pushed forward and bulge outwards (proptosis).

OBI PHARMA: Granted FDA Orphan Drug Designation for the Treatment of Pancreatic Cancer for Its Antibody-Drug Conjugate (ADC) Targeted Cancer Therapy, OBI-999

First Orphan Drug Designation for OBI-999, a novel first-in-class Antibody-Drug Conjugate targeting Globo H, a glycolipid antigen found on multiple tumor types

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