Mineralys Therapeutics Closes $40 Million Series A Funding
Financing Co-led by HBM Healthcare Investments and Samsara BioCapital Food and Drug Administration Accepts Investigational New Drug Application for MLS-101 and Advances to Phase 2 Proof-of-Concept Clinical Trial Company Announces Jon Congleton as Chi... Biopharmaceuticals, Cardiology, Venture Capital, Personnel Mineralys Therapeutics, aldosterone synthase, hypertension (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - April 6, 2021 Category: Pharmaceuticals Source Type: news

Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers Guidance for Industry
Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers Guidance for Industry (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 5, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

United Therapeutics gets another FDA approval for pulmonary hypertension therapy
United Therapeutics (NASDAQ: UTHR) has received another Food and Drug Administration approval for Tyvaso more than a decade after the agency first approved the therapy for treatment of pulmonary arterial hypertension.   The FDA approved a supplemental new drug application for the use of Tyvaso Inhalation Solution, an inhaled form of the drug trepostinil, to increase exercise ability in patients with pulmonary hypertension resulting from interstitial lung disease (PH-ILD), United Therapeutics said… (Source: bizjournals.com Health Care News Headlines)
Source: bizjournals.com Health Care News Headlines - April 1, 2021 Category: Health Management Authors: Rebecca Cooper Source Type: news

United Therapeutics gets another FDA approval for pulmonary hypertension therapy
United Therapeutics (NASDAQ: UTHR) has received another Food and Drug Administration approval for Tyvaso more than a decade after the agency first approved the therapy for treatment of pulmonary arterial hypertension.   The FDA approved a supplemental new drug application for the use of Tyvaso Inhalation Solution, an inhaled form of the drug trepostinil, to increase exercise ability in patients with pulmonary hypertension resulting from interstitial lung disease (PH-ILD), United Therapeutics said… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - April 1, 2021 Category: Biotechnology Authors: Rebecca Cooper Source Type: news

United Therapeutics gets another FDA approval for pulmonary hypertension therapy
United Therapeutics (NASDAQ: UTHR) has received another Food and Drug Administration approval for Tyvaso more than a decade after the agency first approved the therapy for treatment of pulmonary arterial hypertension.   The FDA approved a supplemental new drug application for the use of Tyvaso Inhalation Solution, an inhaled form of the drug trepostinil, to increase exercise ability in patients with pulmonary hypertension resulting from interstitial lung disease (PH-ILD), United Therapeutics said… (Source: bizjournals.com Health Care News Headlines)
Source: bizjournals.com Health Care News Headlines - April 1, 2021 Category: Health Management Authors: Rebecca Cooper Source Type: news

United Therapeutics gets another FDA approval for pulmonary hypertension therapy
United Therapeutics (NASDAQ: UTHR) has received another Food and Drug Administration approval for Tyvaso more than a decade after the agency first approved the therapy for treatment of pulmonary arterial hypertension.   The FDA approved a supplemental new drug application for the use of Tyvaso Inhalation Solution, an inhaled form of the drug trepostinil, to increase exercise ability in patients with pulmonary hypertension resulting from interstitial lung disease (PH-ILD), United Therapeutics said… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - April 1, 2021 Category: Biotechnology Authors: Rebecca Cooper Source Type: news

CTI BioPharma Announces Completion of Rolling Submission of New Drug Application (NDA) for Pacritinib in Myelofibrosis Patients with Severe Thrombocytopenia
Commercial Preparations Underway to Support Potential Approval and Launch of Pacritinib in the United States in 2021 SEATTLE, March 31, 2021 -- (Healthcare Sales & Marketing Network) -- CTI BioPharma Corp. (Nasdaq: CTIC) today announced that it has com... Biopharmaceuticals, FDA CTI BioPharma, pacritinib, myelofibrosis, thrombocytopenia (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - March 31, 2021 Category: Pharmaceuticals Source Type: news

Akebia Submits New Drug Application (NDA) to the FDA for Vadadustat for the Treatment of Anemia Due to Chronic Kidney Disease in Adult Patients on Dialysis and Not on Dialysis
CAMBRIDGE, Mass., March 30, 2021 /PRNewswire/ -- Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose of bettering the lives of people impacted by kidney disease, today announced that it has submitted... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 30, 2021 Category: Drugs & Pharmacology Source Type: news

U.S. FDA Accepts AbbVie's New Drug Application for Atogepant for the Preventive Treatment of Migraine
NORTH CHICAGO, Ill., March 30, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for atogepant, an investigational orally administered... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 30, 2021 Category: Drugs & Pharmacology Source Type: news

Mirum Pharmaceuticals Announces FDA Acceptance of New Drug Application and Priority Review for Maralixibat in Alagille Syndrome
FOSTER CITY, Calif.--(BUSINESS WIRE)--Mar. 29, 2021-- Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) announced today that its New Drug Application (NDA) for maralixibat, an oral apical sodium dependent bile acid transporter (ASBT) inhibitor... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 29, 2021 Category: Drugs & Pharmacology Source Type: news

TG Therapeutics Completes Rolling Submission of Biologics License Application to the U.S. Food and Drug Administration for Ublituximab in Combination with Ukoniq (umbralisib) as a Treatment for Patients with Chronic Lymphocytic Leukemia
NEW YORK, March 29, 2021 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the completion of the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) requesting approval... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 29, 2021 Category: Drugs & Pharmacology Source Type: news

Mezzion Announces Re-Submission of New Drug Application for its Orphan Drug Udenafil to Treat Patients who have undergone the Fontan Operation for Single Ventricle Heart Disease
SEOUL, South Korea, March 28, 2021 /PRNewswire/ -- Mezzion Pharma Co. Ltd. (140410.KQ), announced today that it has re-submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the approval of... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 28, 2021 Category: Drugs & Pharmacology Source Type: news

U.S. Food and Drug Administration (FDA) Accepts Bristol Myers Squibb ’s Application for Mavacamten in Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)
PRINCETON, N.J.--(BUSINESS WIRE)-- March 19, 2021 -- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for mavacamten, an investigational, novel, oral,... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 19, 2021 Category: Drugs & Pharmacology Source Type: news

Merck Receives Priority Review From FDA for New Drug Application for HIF-2 α Inhibitor Belzutifan (MK-6482)
KENILWORTH, N.J.--(BUSINESS WIRE) March 16, 2021 -- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a New Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 16, 2021 Category: Drugs & Pharmacology Source Type: news

Calliditas Announces Submission of New Drug Application to U.S. FDA for Nefecon in Patients with Primary IgA Nephropathy
Mar 15, 2021 -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Nefecon, a novel oral... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 15, 2021 Category: Drugs & Pharmacology Source Type: news

BioXcel Therapeutics Submits New Drug Application to U.S. Food and Drug Administration for BXCL501 for the Acute Treatment of Agitation Associated with Schizophrenia and Bipolar Disorders
NEW HAVEN, Conn., March 11, 2021 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BioXcel” or the“Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 11, 2021 Category: Drugs & Pharmacology Source Type: news

Marius Pharmaceuticals Receives PDUFA Date for Kyzatrex NDA for Treatment of Hypogonadism
RALEIGH, N.C., March 11, 2021– Marius Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 31, 2021 for the review of the Kyzatrex® New... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 11, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Accepts the New Drug Application for Review of Idorsia ’s Daridorexant for the Treatment of Adult Patients with Insomnia
Allschwil, Switzerland– March 10, 2021 Idorsia Ltd (SIX: IDIA) today announced that the US Food and Drug Administration (FDA) has accepted the new drug application (NDA) for review of Idorsia’s investigational dual orexin receptor... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 10, 2021 Category: Drugs & Pharmacology Source Type: news

Kadmon Announces U.S. FDA Has Extended the Review Period for Belumosudil in Chronic Graft-Versus-Host Disease
NEW YORK, NY / ACCESSWIRE / March 10, 2021 / Kadmon Holdings, Inc. (NASDAQ:KDMN) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 10, 2021 Category: Drugs & Pharmacology Source Type: news

Coronavirus Pandemic Forces FDA to Sharply Curtail Drug Company Inspections
The steep decline in oversight has stalled a number of new drug applications. The agency says it is trying to protect its employees but critics say inspectors should be considered essential workers and do their jobs. (Source: NYT Health)
Source: NYT Health - March 9, 2021 Category: Consumer Health News Authors: Sheila Kaplan Tags: Drugs (Pharmaceuticals) Shortages Factories and Manufacturing Medicine and Health Food and Drug Administration Bristol Myers Squibb Company Mylan Inc Spectrum Pharmaceuticals Inc Nivagen Biocon Biologics your-feed-healthcare Source Type: news

Vifor Pharma and Cara Therapeutics Announce U.S. FDA Acceptance and Priority Review of NDA for Korsuva Injection in Hemodialysis Patients With Moderate-to-Severe Pruritus
St.Gallen, Switzerland, and Stamford, Conn., 8 March 2021–Vifor Pharma and Cara Therapeutics, Inc. (Nasdaq: CARA) today announced  that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the New Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 8, 2021 Category: Drugs & Pharmacology Source Type: news

Natco's marketing partner gets USFDA nod for cancer treatment drug
"Breckenridge Pharmaceutical Inc (BPI) has received final approval for its abbreviated new drug application (ANDA) for Everolimus tablets from the US Food and Drug Administration (USFDA)," Natco Pharma said in a regulatory filing. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - March 8, 2021 Category: Pharmaceuticals Source Type: news

Janssen Announces 96-week Results of Phase 3b Study Demonstrating the Continued Safety and Efficacy of Long-acting HIV Treatment of Rilpivirine and Cabotegravir
CORK, IRELAND, March 6, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today presented positive long-term data from the global Phase 3b trial of the first complete, long-acting (LA), two-drug injectable regimen (consisting of Janssen’s rilpivirine and ViiV Healthcare’s cabotegravir) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults. The 96-week findings of the Antiretroviral Therapy as Long-Acting Suppression Every 2 Months (ATLAS-2M) trial confirmed the primary endpoint, met at Week 48, and met the secondary endpoint, showing efficacy of both month...
Source: Johnson and Johnson - March 6, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Shilpa Medicare gets tentative American health regulator nod for Apremilast tablets
The company has received tentative approval from US Food and Drug Administration for its abbreviated new drug application (ANDA) Apremilast tablets in the strengths of 10 mg, 20 mg, and 30 mg, Shilpa Medicare said in a regulatory filing. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - March 5, 2021 Category: Pharmaceuticals Source Type: news

Alembic Pharma's JV Aleor Dermaceuticals gets American regulator nod for Testosterone Gel
Aleor Dermaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its ANDA for its abbreviated new drug application (ANDA) for Testosterone Gel, 1.62%, Alembic Pharmaceuticals said in a regulatory filing. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - March 4, 2021 Category: Pharmaceuticals Source Type: news

Strongbridge Biopharma files new drug application with FDA for rare disease therapy
The new drug candidate targets a condition that afflicts about 8,000 people in the United States. (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - March 3, 2021 Category: Pharmaceuticals Authors: John George Source Type: news

U.S. FDA Expands Approval of Pfizer ’s Lorbrena as First-Line Treatment for ALK-Positive Metastatic Lung Cancer
NEW YORK--(BUSINESS WIRE) March 03, 2021 -- The U.S. Food and Drug Administration (FDA) approved Pfizer Inc.’s (NYSE: PFE) supplemental New Drug Application (sNDA) for Lorbrena® (lorlatinib), expanding the indication to include first-line... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - March 3, 2021 Category: Drugs & Pharmacology Source Type: news

Oyster Point Pharma Announces FDA Acceptance for Filing New Drug Application for OC-01 (varenicline) Nasal Spray for the Treatment of Signs and Symptoms of Dry Eye Disease
PRINCETON, N.J., March 02, 2021 (GLOBE NEWSWIRE) -- Oyster Point Pharma, Inc. (Nasdaq: OYST), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical therapies to treat... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 2, 2021 Category: Drugs & Pharmacology Source Type: news

Strongbridge Biopharma plc Announces Submission of New Drug Application for Recorlev (levoketoconazole) for the Treatment of Endogenous Cushing ’s Syndrome to the FDA
DUBLIN, Ireland and TREVOSE, Pa., March 02, 2021 (GLOBE NEWSWIRE) -- Strongbridge Biopharma plc, (Nasdaq: SBBP), a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 2, 2021 Category: Drugs & Pharmacology Source Type: news

Eyenovia Announces FDA Acceptance of the MydCombi NDA
NEW YORK--(BUSINESS WIRE)--Mar. 2, 2021-- Eyenovia, Inc. (NASDAQ: EYEN), a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose array print (MAP™) therapeutics, today announced that the U.S.... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 2, 2021 Category: Drugs & Pharmacology Source Type: news

U.S. FDA Accepts Merck ’s Gefapixant New Drug Application for Review
KENILWORTH, N.J.--(BUSINESS WIRE) March 1, 2021 -- Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s New Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 1, 2021 Category: Drugs & Pharmacology Source Type: news

Reata Pharmaceuticals, Inc. Submits NDA for Company ’s Lead Program: Bardoxolone in Alport Syndrome
PLANO, Texas, March 01, 2021 (GLOBE NEWSWIRE)— Reata Pharmaceuticals, Inc. (Nasdaq: RETA) (“Reata,” the“Company,” or“we”), a clinical-stage biopharmaceutical company, today announced... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 1, 2021 Category: Drugs & Pharmacology Source Type: news

Avadel Pharmaceuticals Announces FDA Acceptance of New Drug Application for FT218 in Adults with Narcolepsy for the Treatment of Excessive Daytime Sleepiness and Cataplexy
DUBLIN, Ireland, March 01, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company’s New Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 1, 2021 Category: Drugs & Pharmacology Source Type: news

Allergan Submits New Drug Application for Investigational AGN-190584 for the Treatment of Presbyopia
NORTH CHICAGO, Ill., Feb. 25, 2021 /PRNewswire/ -- Allergan, an AbbVie (NYSE: ABBV) company, today announced that it has submitted a New Drug Application to the U.S. Food and Drug Administration for investigational AGN-190584... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 25, 2021 Category: Drugs & Pharmacology Source Type: news

Janssen Announces Submission of Supplemental New Drug Application to U.S. FDA by ViiV Healthcare for Expanded Use of CABENUVA (rilpivirine and cabotegravir) as an HIV Treatment for Use Every Two Months
TITUSVILLE, N.J., February 24, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that a supplemental New Drug Application (sNDA) has been submitted to the U.S. Food and Drug Administration (FDA) by ViiV Healthcare for the expanded use of CABENUVA (consisting of Janssen’s long-acting rilpivirine and ViiV Healthcare’s cabotegravir). The sNDA seeks to expand the CABENUVA label to include administration every two months for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in virologically suppressed adults (HIV-1 RNA less than 50 copies per mL) on a sta...
Source: Johnson and Johnson - February 24, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

USFDA rules against Sun Pharma Advanced Research Co's appeal regarding cancer drug application
The Office of New Drugs (OND) of the US Food and Drug Administration (FDA) has denied the company's appeal of the Complete Response Letter (CRL) in relation to the New Drug Application (NDA) for Taclantis, Sun Pharma Advanced Research Company (SPARC) said in a regulatory filing. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - February 23, 2021 Category: Pharmaceuticals Source Type: news

Incyte Announces Acceptance and Priority Review of NDA for Ruxolitinib Cream for Atopic Dermatitis
WILMINGTON, Del.--(BUSINESS WIRE) February 19, 2021 -- Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for ruxolitinib cream, a selective JAK1/JAK2... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 19, 2021 Category: Drugs & Pharmacology Source Type: news

Lupin launches Posaconazole delayed-release tablets
In a regulatory filing, Lupin Ltd announced launch of Posaconazole delayed-release tablets, 100 mg, after its alliance partner AET Pharma US Inc. received an approval for its abbreviated new drug application from USFDA. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - February 17, 2021 Category: Pharmaceuticals Source Type: news

Genmab and Seagen Submit Tisotumab Vedotin Biologics License Application to the U.S. FDA for Patients with Recurrent or Metastatic Cervical Cancer
COPENHAGEN, Denmark and BOTHELL, Wash.; Feb 10, 2021– Genmab A/S (Nasdaq: GMAB) and Seagen Inc. (Nasdaq: SGEN) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 10, 2021 Category: Drugs & Pharmacology Source Type: news

Supernus Resubmits New Drug Application for SPN-812 for the Treatment of ADHD in Pediatric Patients
ROCKVILLE, Md., Feb. 08, 2021 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 8, 2021 Category: Drugs & Pharmacology Source Type: news

BioCryst Announces FDA Approval of Supplemental New Drug Application for Rapivab Expanding Patient Population to Include Children Six Months and Older
RESEARCH TRIANGLE PARK, N.C., Feb. 03, 2021 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application for Rapivab®... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - February 3, 2021 Category: Drugs & Pharmacology Source Type: news

Novel Oral Testosterone Therapy Headed to FDA Novel Oral Testosterone Therapy Headed to FDA
Marius Pharmaceuticals has submitted a new drug application for Kyzatrex, an oral testosterone replacement therapy.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - February 1, 2021 Category: Consumer Health News Tags: Diabetes & Endocrinology News Source Type: news

Mirum Pharmaceuticals Announces Completion of Rolling NDA Submission for Maralixibat in Alagille Syndrome
FOSTER CITY, Calif.--(BUSINESS WIRE)--Feb. 1, 2021-- Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced it has completed submission of its rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - February 1, 2021 Category: Drugs & Pharmacology Source Type: news

Granules arm gets American health regulator's nod for Potassium Chloride Oral Solution
In a BSE filing, Granules said the US Food and Drug Administration (USFDA) has approved the abbreviated new drug application (ANDA) filed by Granules Pharmaceuticals, Inc (GPI), a wholly-owned foreign subsidiary of Granules India Ltd, for Potassium Chloride Oral Solution USP. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - February 1, 2021 Category: Pharmaceuticals Source Type: news

Biogen and Eisai Announce FDA ’s 3-Month Extension of Review Period for the Biologics License Application for Aducanumab
CAMBRIDGE, Mass. and TOKYO, Jan. 29, 2021 (GLOBE NEWSWIRE) -- Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period by three months for the Biologics... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 29, 2021 Category: Drugs & Pharmacology Source Type: news

Division of Oncology 2 (DO2)
The Division of Oncology 2 (DO2) regulates Investigational New Drug Applications (INDs), New Drug Applications (NDAs) and Biologic Licensing Applications (BLAs) for the following therapeutic areas: gastrointestinal, lung, and head and neck cancers; neuro-oncology, rare cancers, pediatric (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 28, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Unichem Labs gets USFDA nod to market generic capsules
The company has received abbreviated new drug application (ANDA) approval to market its Zonisamide capsules, USP 25 mg, 50 mg and 100 mg from the United States Food and Drug Administration (USFDA), Unichem Laboratories said in a BSE filing. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - January 27, 2021 Category: Pharmaceuticals Source Type: news

Johnson & Johnson Reports 2020 Fourth-Quarter and Full Year Results
New Brunswick, N.J. (January 26, 2021) – Johnson & Johnson (NYSE: JNJ) today announced results for fourth-quarter and full year 2020. “Our notable full year performance reflects the continued confidence from patients, physicians, customers and consumers in our life-enhancing products and medicines, particularly throughout the COVID-19 pandemic,” said Alex Gorsky, Chairman and Chief Executive Officer. “I’m incredibly proud of our Johnson & Johnson teams around the world for going above and beyond to meet stakeholder needs. These efforts, and our commitment to families around the world a...
Source: Johnson and Johnson - January 26, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Iterum Therapeutics Announces U.S. FDA Filing Acceptance of New Drug Application for Oral Sulopenem
DUBLIN, Ireland and CHICAGO, Jan. 25, 2021 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (the Company), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 25, 2021 Category: Drugs & Pharmacology Source Type: news

Albireo Announces U.S. FDA Acceptance of New Drug Application for Odevixibat
BOSTON, Jan. 25, 2021 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage rare liver disease company developing novel bile acid modulators, today announced that the U.S. Food and Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 25, 2021 Category: Drugs & Pharmacology Source Type: news