Approvals

Shire Announces FDA Approval for Label Expansion of CINRYZE® for Prevention of Attacks in Pediatric HAE

June 21, 2018

Dublin, Ireland – Thursday, June 21, 2018 – Shire plc (LSE: SHP, NASDAQ: SHPG), the leading global biotechnology company focused on rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion for CINRYZE® (C1 esterase inhibitor [human]), making it available to help prevent angioedema attacks in children aged […]

Amphastar Announces Approval for Isoproterenol Hydrochloride Injection, USP

June 19, 2018

RANCHO CUCAMONGA, Calif., June 19, 2018 (GLOBE NEWSWIRE) — Amphastar Pharmaceuticals, Inc., (NASDAQ:AMPH) announced that the U.S. Food and Drug Administration (“FDA”) has granted approval of its abbreviated new drug application (“ANDA”) for Isoproterenol Hydrochloride Injection, USP 0.2mg/mL, 1mL and 0.2mg/mL, 5mL single dose vial. Isoproterenol Hydrochloride is indicated for multiple uses including for mild […]

iX Biopharma Obtains Approval and Registration of WAFESIL for the Treatment of Male Erectile Dysfunction in Australia

June 19, 2018

First sublingual wafer sildenafil product for male erectile dysfunction available in Australia  First product in iX Biopharma’s pharmaceutical pipeline utilising WaferiX to receive approval and registration Singapore, 19 June 2018 – iX Biopharma (“iX Biopharma or, together with its subsidiaries, “the Group”) is pleased to announce the approval Therapeutic Goods Administration (“TGA”), the regulatory authority in […]

Dr. Reddy’s Laboratories announces USFDA final approval and launch of Buprenorphine and Naloxone Sublingual Film in the U.S. Market

June 18, 2018

HYDERABAD, India and PRINCETON, N.J., June 15, 2018 /PRNewswire/ — Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) announced today that it has received final approval from the U.S. Food and Drug Administration (USFDA) and is launching Buprenorphine and Naloxone Sublingual Film, 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12 […]

Octapharma announces approval of new Nuwiq® product strengths in Europe, increasing dosing flexibility for patients with haemophilia A

June 18, 2018

LACHEN, Switzerland–(BUSINESS WIRE)–Octapharma announced today that the European Medicines Agency (EMA) has approved an extension of marketing authorisation for its human cell line-derived recombinant factor VIII (rFVIII) product, Nuwiq®. New single dose vial strengths of 2500, 3000 and 4000 International Units (IU) will be available in Europe, in addition to the current strengths of 250, […]

Octapharma announces approval of new Nuwiq® product strengths in Europe, increasing dosing flexibility for patients with haemophilia A

June 18, 2018

LACHEN, Switzerland–(BUSINESS WIRE)–Octapharma announced today that the European Medicines Agency (EMA) has approved an extension of marketing authorisation for its human cell line-derived recombinant factor VIII (rFVIII) product, Nuwiq®. New single dose vial strengths of 2500, 3000 and 4000 International Units (IU) will be available in Europe, in addition to the current strengths of 250, […]

FDA approves first generic versions of Suboxone sublingual film, which may increase access to treatment for opioid dependence

June 15, 2018

The U.S. Food and Drug Administration today approved the first generic versions of Suboxone (buprenorphine and naloxone) sublingual film (applied under the tongue) for the treatment of opioid dependence. “The FDA is taking new steps to advance the development of improved treatments for opioid use disorder, and to make sure these medicines are accessible to […]

China National Drug Administration Approves Country’s First Immuno-Oncology Agent, Opdivo (nivolumab injection), for Previously Treated Non-Small Cell Lung Cancer (NSCLC)

June 15, 2018

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) announced today that the China National Drug Administration (CNDA) has approved Opdivo (nivolumab injection) for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior platinum-based chemotherapy in adult patients without EGFR or ALK genomic tumor aberrations. This is China’s first and only PD-1 […]

FDA Approves Genentech’s Avastin (Bevacizumab) Plus Chemotherapy As A Treatment For Women With Advanced Ovarian Cancer Following Initial Surgery

June 14, 2018

SOUTH SAN FRANCISCO, Calif. – June 13, 2018 – 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 Avastin (bevacizumab) in combination with chemotherapy (carboplatin and paclitaxel), followed by Avastin as a single agent, for the treatment of women with […]

Merck’s Keytruda Snags I-O’s First Cervical Cancer Nod To Back Up HPV Fighter Gardasil

June 14, 2018

Merck’s Keytruda has a new indication, and with it, immunotherapy has moved into a new frontier. With a Tuesday FDA green light for certain previously treated cervical cancer patients whose disease has worsened on or after chemotherapy, Keytruda became the first drug in its class to win a nod to treat those with the disease. […]

Certara Supports the Not-for-profit Biotechnology Company Medicines Development for Global Health (MDGH) on the FDA New Drug Approval of Moxidectin for the Treatment of River Blindness (Onchocerciasis), a Neglected Tropical Disease

June 14, 2018

Certara was privileged to participate as a key member of the Medicines Development for Global Health development team to achieve FDA approval of moxidectin Certara®, the global leader in model-informed drug development, regulatory science, market access and real-world evidence services, today celebrated an important milestone for its public health drug development and treatment consulting portfolio. […]

ALECENSARO® (alectinib) approved by Health Canada for first-line treatment of ALK-positive lung cancer

June 13, 2018

MISSISSAUGA, ON, June 13, 2018 /CNW/ – Hoffmann-La Roche Limited (Roche Canada) announced today that Health Canada has approved ALECENSARO as a monotherapy for the first-line treatment of patients with anaplastic lymphoma kinase (ALK)-positive locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC).1 The approval is based on results from […]

European Commission Approves Prolia® (denosumab) for Patients With Glucocorticoid-Induced Osteoporosis

June 11, 2018

THOUSAND OAKS, Calif., June 8, 2018 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the European Commission (EC) has approved a new indication for Prolia® (denosumab) for the treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture. The EC approval is based on the positive results of […]

FDA Approves Genentech’s Rituxan (Rituximab) for Pemphigus Vulgaris

June 11, 2018

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 Rituxan® (rituximab) for the treatment of adults with moderate to severe pemphigus vulgaris (PV), a rare, serious, potentially life-threatening condition characterized by progressive painful blistering of the skin and mucous membranes.1 […]

Genentech Announces FDA Approval for Venclexta Plus Rituxan for People With Previously Treated Chronic Lymphocytic Leukemia

June 11, 2018

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Venclexta® (venetoclax) in combination with Rituxan ® (rituximab) for the treatment of people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received […]

AbbVie Announces U.S. FDA Approval of VENCLEXTA® (venetoclax tablets) in Combination with Rituximab as a Fixed Duration Treatment for Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Patients Who Have Received One Prior Therapy

June 11, 2018

NORTH CHICAGO, Ill., June 8, 2018 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has approved, under priority review, VENCLEXTA® (venetoclax tablets) in combination with rituximab for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without […]

Allergan’s RESTASIS MULTIDOSE™ (Cyclosporine Ophthalmic Emulsion) 0.05% Approved in Canada

June 8, 2018

MARKHAM, ON, June 7, 2018 /CNW/ – Allergan plc announced today that it has received approval from Health Canada for RESTASIS MULTIDOSE™ (Cyclosporine Ophthalmic Emulsion) 0.05%.   RESTASIS MULTIDOSE™ is a preservative-free, multi-dose bottle offering the same preservative-free formulation of RESTASIS®, in a new, easy-to-use multi-dose bottle. RESTASIS® is the leading^* treatment approved in Canada […]

Partner Therapeutics (PTx) Announces US FDA Approval of Leukine® (sargramostim) for the Treatment of Acute Radiation Syndrome

June 6, 2018

LEXINGTON, Mass., June 6, 2018 /PRNewswire/ — Commercial-stage cancer biotech company, Partner Therapeutics, Inc. (PTx), announced the recent FDA approval of Leukine for the treatment of adult and pediatric patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome, or H-ARS). Leukine is the first drug for H-ARS to demonstrate an […]

FDA approves first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment

June 5, 2018

The U.S. Food and Drug Administration today approved Fulphila (pegfilgrastim-jmdb) as the first biosimilar to Neulasta (pegfilgrastim) to decrease the chance of infection as suggested by febrile neutropenia (fever, often with other signs of infection, associated with an abnormally low number of infection-fighting white blood cells), in patients with non-myeloid (non-bone marrow) cancer who are […]

U.S. FDA Approves Mylan and Biocon’s Fulphila™ (pegfilgrastim-jmdb), the First Biosimilar to Neulasta®

June 5, 2018

HERTFORDSHIRE, England/PITTSBURGH and BENGALURU, India June 4, 2018 — Mylan N.V. (NASDAQ: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food and Drug Administration (FDA) has approved Mylan’s Fulphila™ (pegfilgrastim-jmbd), a biosimilar to Neulasta® (pegfilgrastim), co-developed with Biocon. Fulphila has been approved to reduce the duration of febrile neutropenia […]

FDA Expands Lilly’s ALIMTA® (pemetrexed) Label to Include Combination with KEYTRUDA® (pembrolizumab) and Carboplatin as First-Line Treatment for Metastatic Nonsquamous Non-Small Cell Lung Cancer, Irrespective of PD-L1 Expression

June 5, 2018

INDIANAPOLIS, June 5, 2018 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has granted approval for a new indication for ALIMTA®(pemetrexed for injection) in combination with carboplatin and KEYTRUDA® (pembrolizumab) for the initial treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), irrespective […]

NexoBrid® Receives Marketing Authorization From South Korea’s Ministry of Health

June 4, 2018

YAVNE, Israel, June 04, 2018 (GLOBE NEWSWIRE) — MediWound Ltd. (Nasdaq:MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced receipt of authorization from the Ministry of Health in South Korea to market and distribute NexoBrid® for the removal of dead or damaged tissue, known […]

Amphastar Pharmaceuticals Receives FDA Approval for Semi-Purified Heparin at Amphastar Nanjing Pharmaceuticals

June 4, 2018

RANCHO CUCAMONGA, Calif., June 04, 2018 (GLOBE NEWSWIRE) — Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) announced that the U.S. Food and Drug Administration (“FDA”) granted approval of the company’s abbreviated new drug application (“ANDA”) supplement for the manufacture of semi-purified heparin at the company’s subsidiary, Amphastar Nanjing Pharmaceuticals (“ANP”) and the manufacture of heparin sodium USP at […]

Lannett Receives FDA Approval For Levofloxacin Oral Solution; Imminent Launch Anticipated

June 1, 2018

PHILADELPHIA, June 1, 2018 /PRNewswire/ — Lannett Company, Inc. (NYSE: LCI) today announced that it received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Levofloxacin Oral Solution USP, 25 mg/mL, the therapeutic equivalent to the reference listed drug, Levaquin® Oral Solution, 25 mg/mL, of Janssen Pharmaceuticals, […]

TherapeuticsMD Announces FDA Approval of TX-004HR: IMVEXXYTM (estradiol vaginal inserts), the Lowest Dose Vaginal Estrogen Product Approved for the Treatment of Moderate to Severe Dyspareunia, a Symptom of VVA, due to Menopause

June 1, 2018

BOCA RATON, Fla.–(BUSINESS WIRE)—May 30, 2018—TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative women’s healthcare company, today announced that the United States Food and Drug Administration (FDA) has approved IMVEXXYTM (estradiol vaginal inserts) for the treatment of moderate-to-severe dyspareunia (vaginal pain associated with sexual activity), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. IMVEXXY […]

Pfizer Announces U.S. FDA Approves XELJANZ® (tofacitinib) for the Treatment of Moderately to Severely Active Ulcerative Colitis

June 1, 2018

NEW YORK, N.Y., May 30 – Pfizer Inc. (NYSE: PFE) announced today that the United States (U.S.) Food and Drug Administration (FDA) approved XELJANZ® (tofacitinib) 10 mg twice-daily (BID) for at least eight weeks, followed by XELJANZ 5 mg BID or 10 mg BID, for the treatment of adult patients in the U.S. with moderately […]

FDA Accepts Larotrectinib New Drug Application and Grants Priority Review

May 31, 2018

STAMFORD, Conn., May 29, 2018 (GLOBE NEWSWIRE) — Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) and granted Priority Review for larotrectinib for the treatment […]

BioIVT Granted Human Tissue Authority License for a Second UK Site

May 31, 2018

HTA licenses help verify that BioIVT biospecimens meet the highest quality standards.   BioIVT, a leading provider of biospecimens and related services, today announced that the Human Tissue Authority (HTA) has granted a satellite license to its West Sussex facility.   “Our goal is to always provide our customers with the highest quality biospecimens and […]

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