Cumberland drug company raises $3M seed round to develop cannabis-derived lung treatment
A Cumberland drug company has raised $3 million in funding as it works toward gaining approval for a new cannabis-derived treatment for lung diseases. RS BioTherapeutics plans to use the capital from its second seed round to focus on developing a medication for chronic obstructive pulmonary disease, or COPD. Co-founder and Chief Strategy Officer Justin Molignoni said the company will apply for an investigational new drug application from the U.S. Food and Drug Administration and hopes to submit … (Source: bizjournals.com Health Care News Headlines)
Source: bizjournals.com Health Care News Headlines - October 5, 2022 Category: Health Management Authors: Matt Hooke Source Type: news

Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA
This guidance is intended for holders of Type II active pharmaceutical ingredient (API) drug master files (DMFs) that will be referenced in an abbreviated new drug application (ANDA), or a prior approval supplement (PAS) to an ANDA. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - October 3, 2022 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Catalyst Pharmaceuticals Announces FDA Approval of Supplemental New Drug Application for Firdapse Expanding Patient Population to Include Pediatric Patients
Firdapse is Now a Treatment Option for All LEMS Patients 6 Years of Age and Older in the U.S. CORAL GABLES, Fla., Sept. 29, 2022 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ( " Catalyst " ) (Nasdaq: CPRX), a commercial-stage... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 29, 2022 Category: Drugs & Pharmacology Source Type: news

BioMarin Resubmits Biologics License Application (BLA) for Valoctocogene Roxaparvovec AAV Gene Therapy for Severe Hemophilia A to the FDA
BLA Includes Substantial Body of Data from Pivotal Phase 3 and Ongoing Phase 1/2 Studies If Approved, Would Be 1st Gene Therapy in U.S. for Treatment of Severe Hemophilia A SAN RAFAEL, Calif., Sept. 29, 2022 /PRNewswire/ -- BioMarin... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 29, 2022 Category: Drugs & Pharmacology Source Type: news

Spectrum Pharmaceuticals Provides Update on Poziotinib Following FDA Oncologic Drugs Advisory Committee Meeting
BOSTON--(BUSINESS WIRE)--Sep. 22, 2022-- Spectrum Pharmaceuticals (NasdaqGS: SPPI) (“Spectrum” or the“Company”), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced that the U.S.... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 22, 2022 Category: Drugs & Pharmacology Source Type: news

Why Is Biopharma Paying 75% Of The FDA ’s Drug Division Budget?
It decreed that drug companies must pay a “user fee” each time they filed a New Drug Application (NDA). These funds would then be used to support the FDA’s drug division. (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - September 22, 2022 Category: Pharmaceuticals Authors: John LaMattina, Contributor Tags: Healthcare /healthcare Innovation /innovation business pharma Source Type: news

Cidara Therapeutics Announces FDA Acceptance for Priority Review of New Drug Application for Rezafungin for the Treatment of Candidemia and Invasive Candidiasis
Assigned PDUFA target action date of March 22, 2023 SAN DIEGO, Sept. 20, 2022— Cidara Therapeutics, Inc. (NASDAQ: CDTX), a biotechnology company developing long-acting therapeutics designed to improve the standard of care for patients... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 20, 2022 Category: Drugs & Pharmacology Source Type: news

BWXT Medical seeks FDA approval for Tc-99m generator
BWXT Medical has submitted a new drug application to the U.S. Food and Dru...Read more on AuntMinnie.comRelated Reading: Bayer inks deal to buy Ac-225 from BWXT Medical BWXT Medical, TRIUMF ink medical isotope production deal BWXT and Bayer to focus on therapeutic radionuclides BWXT to manufacture Boston Scientific's TheraSphere glass microspheres BWXT, GMS form joint venture for Asia-Pacific (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - September 14, 2022 Category: Radiology Source Type: news

Acadia Pharmaceuticals Announces Trofinetide New Drug Application for the Treatment of Rett Syndrome has been Accepted for Filing and Review by U.S. FDA
NDA granted priority review Prescription Drug User Fee Act action date set for March 12, 2023 SAN DIEGO–(BUSINESS WIRE)–Sep. 12, 2022– Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the U.S. Food and Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 12, 2022 Category: Drugs & Pharmacology Source Type: news

BioLineRx Announces Submission of New Drug Application (NDA) to FDA for Motixafortide in Stem Cell Mobilization
Submission based on overwhelmingly positive top-line results from GENESIS Phase 3 study Stem cell mobilization for bone marrow transplantation estimated to be> $360 million market in the U.S. (> $500 million globally), with consistent... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 12, 2022 Category: Drugs & Pharmacology Source Type: news

FDA and EMA Accept Regulatory Submission for Pfizer ’s Ritlecitinib for Individuals 12 Years and Older with Alopecia Areata
Filings based on clinical data demonstrating significant scalp hair regrowth versus placebo NEW YORK--(BUSINESS WIRE) September 09, 2022 -- Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) accepted for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 9, 2022 Category: Drugs & Pharmacology Source Type: news

Amylyx Pharmaceuticals Announces FDA Advisory Committee Supports Approval of AMX0035 for the Treatment of ALS
FDA Advisory Committee voted 7:2 that the available evidence of effectiveness is sufficient to support approval of AMX0035 for the treatment of ALS If approved, AMX0035 will be the first treatment in ALS that has demonstrated a significant... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 7, 2022 Category: Drugs & Pharmacology Source Type: news

Tarsus Submits New Drug Application to the FDA for TP-03 for the Treatment of Demodex Blepharitis
IRVINE, Calif., Sept. 07, 2022 (GLOBE NEWSWIRE) -- Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), whose mission is to focus on unmet needs and apply proven science and new technology to revolutionize treatment for patients, starting... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 7, 2022 Category: Drugs & Pharmacology Source Type: news

Bausch + Lomb and Novaliq Announce U.S. FDA Filing Acceptance for Investigational Treatment NOV03 (Perfluorohexyloctane)
PDUFA Action Date is June 28, 2023 VAUGHAN, Ontario and HEIDELBERG, Germany, Sept. 6, 2022 /PRNewswire/ -- Bausch + Lomb Corporation (NYSE/TSX: BLCO) ( " Bausch + Lomb " ), a leading global eye health company dedicated to helping people see... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 6, 2022 Category: Drugs & Pharmacology Source Type: news

Aquestive Therapeutics Receives FDA Tentative Approval for Libervant (diazepam) Buccal Film
Libervant provided tentative approval from the FDA for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity Libervant U.S. Market Access currently subject to the expiration of Valtoco® orphan drug market... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 31, 2022 Category: Drugs & Pharmacology Source Type: news