Drugs

March 1, 2023 Audience: Health Professional, Pharmacy, Consumer March 01, 2023 – Weston, Florida, Apotex Corp., with the knowledge of the US FDA, is initiating a voluntary recall at the Consumer level for six (6) lots of Brimonidine Tartrate Ophthalmic Solution, 0.15% specified below. This recall is being initiated out of an abundance of caution

FDA Approves Skyclarys (omaveloxolone) for the Treatment of Friedreich’s Ataxia PLANO, Texas–(BUSINESS WIRE) February 28, 2023 — Reata Pharmaceuticals, Inc. (Nasdaq: RETA) (“Reata,” the “Company,” “our,” “us,” or “we”), a biopharmaceutical company focused on developing and commercializing novel therapies for patients with severe diseases, announced that the U.S. Food and Drug Administration (“FDA”) has approved

Treatment for Presbyopia FDA Accepts Orasis Pharmaceuticals’ New Drug Application for CSF-1 for the Treatment of Presbyopia Investigational, novel eye drop candidate was assigned PDUFA goal date of October 22, 2023 Ponte Vedra, FL, February 21, 2023 – Orasis Pharmaceuticals, an emerging ophthalmic pharmaceutical company focused on developing a unique eye drop to improve near

THOUSAND OAKS, Calif., Feb. 2, 2023 /PRNewswire/ — Amgen (NASDAQ:AMGN) and AstraZeneca today announced the U.S. Food and Drug Administration (FDA) has approved Tezspire® (tezepelumab-ekko) for self-administration in a pre-filled, single-use pen for patients aged 12 years and older with severe asthma.1 First approved by the FDA in December 2021, Tezspire is the only biologic

Takhzyro is the First and Only Prophylaxis Treatment Approved in the U.S. for Children 2 to <6 Years of Age With HAE1-4 Approval Supported by Extrapolation of Efficacy Data From the Phase 3 HELP Study With Additional Data From the Phase 3 SPRING Study in Pediatric Patients 2 to <12 Years of Age1 HAE is

First Trop-2 Directed ADC to Demonstrate Overall Survival Benefit in HR+/HER2- Metastatic Breast Cancer Patients who had Received Prior Endocrine-based Therapy and at Least Two Chemotherapies Trodelvy has Now Improved Survival in both Pre-Treated HR+/HER2- Metastatic Breast Cancer and in Second-Line Metastatic Triple-Negative Breast Cancer FOSTER CITY, Calif.–(BUSINESS WIRE) February 03, 2023 — Gilead Sciences,

February 23, 2023 Audience: Consumers February 23, 2023 — Global Pharma Healthcare is voluntarily recalling Batch No. H29 of Artificial Eye Ointment, distributed by Delsam Pharma to the consumer level, due to possible microbial contamination. Additionally, some product packaging is leaking or may otherwise be compromised. Risk Statement: Use of contaminated eye ointment may cause

TARRYTOWN, N.Y., Feb. 08, 2023 (GLOBE NEWSWIRE) — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Eylea® (aflibercept) Injection to treat preterm infants with retinopathy of prematurity (ROP). Following this first pediatric approval, Eylea is now indicated to treat five retinal conditions caused by ocular angiogenesis.

Label expansion for Cibinqo provides new systemic oral option for adolescents (12 to <18 years) with moderate-to-severe atopic dermatitis NEW YORK–(BUSINESS WIRE) February 10, 2023 — Pfizer Inc. (NYSE: PFE) announced today that the United States (U.S.) Food and Drug Administration (FDA) approved its supplemental New Drug Application (sNDA) for Cibinqo® (abrocitinib), expanding its indication

Conversion from accelerated to regular (full) approval based on long-term outcomes from the GARNET phase I trial, which demonstrated an overall response rate of 45.4% 85.9% of patients had duration of response ≥12 months and 54.7% of patients had duration of response ≥24 months London, UK — 10 February 2023 — GSK plc (LSE/NYSE: GSK)

First and only enzyme replacement therapy for the treatment of non-central nervous system manifestations of alpha-mannosidosis in adult and pediatric patients Ultra-rare progressive disease presents with wide range of symptoms BOSTON, Feb. 16, 2023 /PRNewswire/ — Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group), announced

News FDA Alerts nanoMaterials Discovery Corporation Issues Voluntary Nationwide Recall of its Alcohol Antiseptic 80% Alcohol Solution February 14, 2023 Audience: Consumers February 14, 2023 – Seattle, Washington, nanoMaterials Discovery Corporation is voluntarily recalling all lots of its Alcohol Antiseptic 80% Alcohol Solution branded as “Snowy Range Blue” in four fluid ounce spray dispenser packaging

reproxalap Treatment for Dry Eye Disease Aldeyra Therapeutics Announces FDA Acceptance of New Drug Application for Reproxalap for the Treatment of Dry Eye Disease PDUFA Date is November 23, 2023 First-in-Class RASP Modulator Represents a Potential New Therapeutic Paradigm for Patients Suffering from Dry Eye Disease LEXINGTON, Mass.–(BUSINESS WIRE)–Feb. 7, 2023– Aldeyra Therapeutics, Inc. (Nasdaq:

FDA Grants Accelerated Approval to Filspari (sparsentan) for the Reduction of Proteinuria in IgA Nephropathy First single molecule Dual Endothelin Angiotensin Receptor Antagonist (DEARA) approved for use in patients with IgA nephropathy (IgAN) Interim results from the ongoing Phase 3 PROTECT head-to-head trial demonstrated a rapid, sustained and clinically meaningful reduction in proteinuria vs. active

FDA Approves Syfovre (pegcetacoplan injection) for the Treatment of Geographic Atrophy, a Leading Cause of Blindness WALTHAM, Mass., Feb. 17, 2023 (GLOBE NEWSWIRE) — Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced that the U.S. Food and Drug Administration (FDA) has approved Syfovre™ (pegcetacoplan injection) for the treatment

TOKYO, Feb. 19, 2023 /PRNewswire/ — Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced the U.S. Food and Drug Administration (FDA) notified the company that it is extending the original priority review Prescription Drug User Fee Act (PDUFA) goal date for fezolinetant, an investigational agent for the treatment of

New once-daily Austedo XR regimen now approved in 6, 12, and 24 mg tablet strengths Austedo is the only vesicular monoamine transporter 2 (VMAT2) inhibitor approved for both tardive dyskinesia (TD) and chorea associated with Huntington’s disease (HD) indications1,2 Austedo is the only VMAT2 inhibitor with 3-year long-term data for both TD and HD chorea1,2

Treatment for Depression Fabre-Kramer Submits NDA Amendment for Exxua™ for Treatment of Major Depressive Disorder HOUSTON, Jan. 4, 2023 /PRNewswire/ — Fabre-Kramer Pharmaceuticals, Inc. (Fabre-Kramer) today announced that on December 23, 2022, it filed an NDA Amendment with the Food and Drug Administration (FDA) for its novel mechanism antidepressant Exxua™ (gepirone ER) for treatment of

News New Drug Applications Fabre-Kramer Pharmaceuticals Announces FDA Acceptance of NDA Resubmission as Complete Response and Assignment of PDUFA Regulatory Action Date Treatment for Depression Fabre-Kramer Pharmaceuticals Announces FDA Acceptance of NDA Resubmission as Complete Response and Assignment of PDUFA Regulatory Action Date HOUSTON, Jan. 24, 2023 — Fabre-Kramer Pharmaceuticals, a leading developer of novel

rezafungin Treatment for Candidemia, Systemic Candidiasis Cidara Therapeutics and Melinta Therapeutics Announce FDA Advisory Committee Recommends Approval of Rezafungin for the Treatment of Candidemia and Invasive Candidiasis FDA decision expected by PDUFA target action date of March 22, 2023 If approved, rezafungin will be the first new drug for the treatment of candidemia and invasive

News FDA Alerts Public Notification: Alfia Weight Loss Capsules Contain Hidden Drug Ingredient February 8, 2023 Audience: Consumers February 8, 2023 — The Food and Drug Administration is advising consumers not to purchase or use Alfia Weight Loss Capsules, a product promoted and sold for weight loss on various websites including, https://alfia.com, and possibly in

Treatment for Reversal of Pharmacologically Induced Mydriasis Ocuphire Announces FDA Acceptance of New Drug Application and PDUFA Date for Nyxol Eye Drops for Reversal of Mydriasis FARMINGTON HILLS, Mich., Feb. 13, 2023 (GLOBE NEWSWIRE) — Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of

February 13, 2023 – Pomona, California, Volt Candy is voluntarily recalling one lot of PrimeZen Black 6000, 2000 mg capsule, to the consumer level. FDA analysis has found PrimeZen Black 6000 capsules to be tainted with sildenafil & tadalafil. Sildenafil and tadalafil are phosphodiesterase (PDE-5) inhibitors found in FDA-approved products for the treatment of male

zuranolone Treatment for Major Depressive Disorder, Postpartum Depression Biogen and Sage Therapeutics Announce FDA Accepts Filing of New Drug Application and Grants Priority Review of Zuranolone in the Treatment of Major Depressive Disorder and Postpartum Depression Zuranolone is being evaluated as a potential 14-day, rapid-acting, once-daily, oral medication to treat major depressive disorder (MDD) and

News FDA Alerts Infants at Risk for Aluminum Toxicity with Unapproved Potassium Phosphates Drug Product February 9, 2023 Audience: Consumers February 9, 2023 — FDA is warning health care professionals and pharmacies to avoid using Hospira’s unapproved potassium phosphates drug product in pediatric patients because the aluminum exposure from this product is unsafe for this

News FDA Alerts FDA Warns Consumers Not to Purchase or Use EzriCare Artificial Tears Due to Potential Contamination February 2, 2023 Audience: Consumers February 2, 2023 — FDA is warning consumers and health care practitioners not to purchase and immediately stop using EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears due to potential bacterial contamination.

FDA Approves Jesduvroq (daprodustat) for Anemia Caused by Chronic Kidney Disease for Adults on Dialysis February 01, 2023 — Today, the U.S. Food and Drug Administration approved Jesduvroq tablets (daprodustat) as the first oral treatment for anemia (decreased number of red blood cells) caused by chronic kidney disease for adults who have been receiving dialysis

February 01, 2023 — IBSA Pharma Inc. is voluntarily recalling 27 lots of TIROSINT®-SOL (levothyroxine sodium) Oral Solution to the consumer level. This voluntary recall has been initiated because these lots may be subpotent. The company’s analyses show a slight decrease below 95.0% of its labeled amount in levothyroxine sodium (T4) for some lots. This