Drugs

Print this page 20 May 2020 — AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) today announced that Lynparza (olaparib) has been approved in the US for patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). The approval by the US

FDA Approves Phexxi (lactic acid, citric acid and potassium bitartrate) Non-Hormonal Prescription Gel for the Prevention of Pregnancy Print this page SAN DIEGO, May 22, 2020 /PRNewswire/ – Evofem Biosciences, Inc. (NASDAQ: EVFM) today announced that the U.S. Food and Drug Administration (FDA) has approved Phexxi™ (lactic acid, citric acid and potassium bitartrate) vaginal gel for the prevention of

May 22, 2020 Print this page Audience: Consumer, Health Professional, Pharmacy May 22, 2020 — Acella Pharmaceuticals, LLC is voluntarily recalling a total of 13 lots of 30-mg, 60-mg and 90-mg NP Thyroid® (thyroid tablets, USP) to the consumer level. The products are being recalled because our testing has found these lots to be superpotent.

Treatment for Progeria and Progeroid Laminopathies Eiger BioPharmaceuticals Announces FDA Acceptance of NDA for Filing with Priority Review of Zokinvy (lonafarnib) for Treatment of Progeria and Progeroid Laminopathies Print this page PALO ALTO, Calif. May 19, 2020 — Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for serious rare and

FDA Approves Kynmobi (apomorphine hydrochloride) Sublingual Film for the Treatment of Parkinson’s Disease OFF Episodes Print this page MARLBOROUGH, Mass.–(BUSINESS WIRE) May 21, 2020 –Sunovion Pharmaceuticals Inc. (Sunovion) announced today that the U.S. Food and Drug Administration (FDA) has approved Kynmobi (apomorphine HCI) sublingual film (APL-130277) for the acute, intermittent treatment of OFF episodes in

News FDA Alerts Biota Biosciences Issues Voluntary Nationwide Recall of Cannabidiol (CBD) Complex, Curcumin Complex, and Cannabidiol + Curcumin Injectables Because They Were Marketed Without FDA Approval May 20, 2020 Print this page Audience: Consumer, Health Professional, Pharmacy May 20, 2020 — Biota Biosciences is voluntarily recalling the following lots in the table below of

Treatment for Opioid Overdose Adamis Pharmaceuticals Resubmits Zimhi New Drug Application to FDA Print this page SAN DIEGO, May 18, 2020 (GLOBE NEWSWIRE) — Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today announced the resubmission of the Company’s New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for its Zimhi™ (naloxone HCI Injection, USP)

Print this page South San Francisco, CA — May 18, 2020 — Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Tecentriq ® (atezolizumab) as a first-line (initial) treatment for adults with metastatic non-small cell lung cancer (NSCLC) whose tumors have high

sutimlimab Treatment for Cold Agglutinin Disease (CAD) FDA Grants Priority Review of Sutimlimab, Potential First Approved Treatment of Hemolysis in Adult Patients with Cold Agglutinin Disease Print this page PARIS – May 14, 2020 - The U.S. Food and Drug Administration (FDA) has granted priority review of Sanofi’s Biologics License Application (BLA) for sutimlimab for the

Treatment for Dry Eye Disease Kala Pharmaceuticals Resubmits New Drug Application for Eysuvis for Dry Eye Disease Print this page WATERTOWN, Mass.–(BUSINESS WIRE)–May 4, 2020– Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, today announced that it has resubmitted its New

FDA Approves Qinlock (ripretinib) for the Treatment of Fourth-Line Gastrointestinal Stromal Tumor Print this page WALTHAM, Mass.–(BUSINESS WIRE)–May 15, 2020– Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) today announced the U.S. Food and Drug Administration (FDA) has approved Qinlock™ (ripretinib) for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with

setmelanotide Treatment for Obesity Rhythm Pharmaceuticals Announces FDA Acceptance of New Drug Application for Setmelanotide for the Treatment of POMC and LEPR Deficiency Obesities Print this page BOSTON, May 13, 2020 (GLOBE NEWSWIRE) – Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a late-stage biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic disorders of obesity, today

Print this page BOULDER, Colo.–(BUSINESS WIRE)–May 15, 2020 — Clovis Oncology, Inc. (NASDAQ: CLVS), announced today that the U.S. Food and Drug Administration (FDA) approved Rubraca® (rucaparib) tablets for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy

Print this page PRINCETON, N.J.–(BUSINESS WIRE)–May 15, 2020 — Bristol Myers Squibb (NYSE: BMY) today announced that Pomalyst ® (pomalidomide) was approved by the U.S. Food and Drug Administration (FDA) for patients with AIDS-related Kaposi sarcoma whose disease has become resistant to highly active antiretroviral therapy (HAART), or in patients with Kaposi sarcoma who are

May 11, 2020 Print this page Audience: Consumer, Health Professional, Pharmacy May 11, 2020 — MasterPharm, LLC. is voluntarily recalling 1 lot of Finasteride Plus 1.25mg, capsules to the consumer level. The Finasteride Plus capsules have been found to contain undeclared minoxidil, an antihypertensive drug, at levels greater than those found in FDA approved products.

leronlimab CytoDyn Submits Completed Biologics License Application (BLA) to the FDA for Leronlimab as a Combination Therapy for Highly Treatment Experienced HIV Patients Print this page VANCOUVER, Washington, April 27, 2020 (GLOBE NEWSWIRE) – CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for

Print this page KENILWORTH, N.J.–(BUSINESS WIRE)–May 8, 2020 — AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Lynparza in combination with bevacizumab as a first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or

FDA Approves Retevmo (selpercatinib) for Patients with Advanced RET-Driven Lung and Thyroid Cancers Print this page INDIANAPOLIS, May 8, 2020 /PRNewswire/ – Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) approved Retevmo™ (selpercatinib, 40 mg & 80 mg capsules), the first therapy specifically indicated for the treatment of adult patients with

May 8, 2020 Print this page Audience: Hospitals and Distributors May 08, 2020 — ICU Medical, Inc. is voluntarily recalling one single lot of Lactated Ringer’s Injection, USP. The products are being recalled to the hospital/user level due to the presence of particulate matter identified as iron oxide. ICU Medical became aware of this issue

Print this page HYDERABAD, India & PRINCETON, N.J.–(BUSINESS WIRE) May 06, 2020 –Dr. Reddy’s Laboratories Ltd., along with its subsidiaries together referred to as “Dr. Reddy’s”) today announced approval of Elyxyb (celecoxib oral solution 25 mg/mL) by the U.S. Food and Drug Administration (USFDA). ELYXYB (previously known as DFN-15) is indicated for the acute treatment

lisocabtagene maraleucel Treatment for Large B-Cell Lymphoma Bristol Myers Squibb Provides Update on Biologics License Application (BLA) for Lisocabtagene Maraleucel (liso-cel) Print this page PRINCETON, N.J.–(BUSINESS WIRE)– May 6, 2020 Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has extended the action date by three months for the

Print this page 6 May 2020 — AstraZeneca’s Farxiga (dapagliflozin) has been approved in the US to reduce the risk of cardiovascular (CV) death and hospitalisation for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction (HFrEF) with and without type-2 diabetes (T2D). The approval by the Food and Drug

Treatment for Acute Myeloid Leukemia U.S. Food and Drug Administration (FDA) Accepts for Priority Review Bristol Myers Squibb’s Application for CC-486 for Maintenance Treatment of Adult Patients in Remission with Acute Myeloid Leukemia Print this page PRINCETON, N.J.–(BUSINESS WIRE) May 1, 2020 –Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug

FDA Approves Tabrecta (capmatinib) for Metastatic Non-Small Cell Lung Cancer with METex14 Print this page EAST HANOVER, N.J., May 6, 2020 /PRNewswire/ – Novartis announced today that the US Food and Drug Administration (FDA) approved Tabrecta™ (capmatinib, formerly INC280), an oral MET inhibitor for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that

FDA Approves Fensolvi (leuprolide acetate) for Injectable Suspension for Pediatric Patients with Central Precocious Puberty Print this page BUFFALO GROVE, Ill., May 4, 2020 /PRNewswire/ — Tolmar Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application for Fensolvi (leuprolide acetate) for injectable suspension for the treatment

April 28, 2020 Print this page Audience: Consumers April 28, 2020 — GSK Consumer Healthcare is voluntarily recalling five lots (listed below) of Benefiber Healthy Shape Prebiotic Fiber Supplement powder and Benefiber Prebiotic Fiber Supplement powder due to the potential for green plastic pieces or shavings from bottle caps to be present in the product.

Print this page KENILWORTH, N.J.–(BUSINESS WIRE) April 28, 2020 –Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved an additional recommended dosage of 400 mg every six weeks (Q6W) for Keytruda, Merck’s anti-PD-1 therapy, across all adult indications, including monotherapy

FDA Approves Darzalex Faspro (daratumumab and hyaluronidase-fihj) for the Treatment of Patients with Multiple Myeloma Print this page HORSHAM, Pa., May 1, 2020 /PRNewswire/ – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) approved Darzalex Faspro (daratumumab and hyaluronidase-fihj), a new subcutaneous formulation of daratumumab. Darzalex Faspro™ is approved in four regimens