Pfizer Inc. (NYSE:PFE) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended against expanding use of SUTENT® (sunitinib) to include the adjuvant treatment of adult patients at a high risk of recurrent renal cell carcinoma (RCC) following nephrectomy (surgical removal of the cancerous kidney). Read More »

Allergan plc, (NYSE: AGN) a leading global pharmaceutical company, and Medicines360, a global nonprofit women's health pharmaceutical company with a mission of expanding access to quality medicines, announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Medicines360's supplemental New Drug Application (sNDA). Read More »

Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) seeking approval of its recently acquired developmental product stannsoporfin. Read More »

One of the U.S. Food and Drug Administration’s highest priorities is our role in ensuring the safety of the foods that Americans consume. Read More »

PDL BioPharma, Inc. (NASDAQ: PDLI) officially announced it will no longer pursue its proposed acquisition of Neos Therapeutics, Inc. (NASDAQ: NEOS). While PDL's last public disclosure announced its proposal expired on November 8, 2017, PDL has maintained its interest until recently making the decision to not make any further proposals. Read More »

Perrigo Company plc issued the following announcement on Feb. 20.Perrigo Company plc (NYSE; TASE: PRGO) today announced that it has filed a Paragraph IV Abbreviated New Drug Application with the U.S. Read More »

Acorda Therapeutics, Inc. (Nasdaq:ACOR) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for INBRIJA. INBRIJA is an investigational inhaled levodopa treatment for symptoms of OFF periods in people with Parkinson’s disease taking a carbidopa/levodopa regimen Read More »

Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) announced that it has licensed IONIS-AZ5-2.5Rx (AZD2373) to the global, science-led biopharmaceutical company AstraZeneca (NYSE: AZN). Read More »

Global pharmaceutical company Mylan N.V. (NASDAQ: MYL) announced receipt of tentative approval from the U.S. Food and Drug Administration (FDA) under the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application for Dolutegravir, Emtricitabine, and Tenofovir Alafenamide Tablets, 50 mg/200 mg/25 mg. Read More »

Upsher-Smith Laboratories, LLC (Upsher-Smith) and the National Alliance of State Pharmacy Associations (NASPA) are proud to honor the 2017 NASPA Excellence in Innovation Award recipients. Read More »

Pfizer Inc. announced its once-daily oral Janus kinase 1 (JAK1) inhibitor PF-04965842 received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with moderate-to-severe atopic dermatitis (AD). The Phase 3 program for PF-04965842 initiated in December and is the first trial in the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) global development program. Read More »

Applied Genetic Technologies Corporation (NASDAQ:AGTC), a biotechnology company conducting human clinical trials of adeno-associated virus (AAV)-based gene therapies for the treatment of rare diseases, today announced the election of Sue Washer, President and Chief Executive Officer, to the Biotechnology Innovation Organization (BIO)'s Board of Directors. Read More »

GSK announced the expanded indication for Fluarix Tetra (Quadrivalent Influenza Vaccine) has been approved in Europe to include adults and now children from six months of age for the prevention of influenza disease caused by the two influenza A virus subtypes and the two influenza B virus types contained in the vaccine. Read More »

Teva Pharmaceutical Industries Ltd. announced that QVAR® RediHaler™ (beclomethasone dipropionate HFA) Inhalation Aerosol is now commercially available to patients in both 40 mcg and 80 mcg strengths by prescription in the U.S. Read More »

Trovagene, Inc. (NASDAQ: TROV), a precision medicine biotechnology company, developing targeted cancer therapeutics, today announced that preclinical data demonstrating the synergy of PCM-075, its highly-selective Polo-like kinase 1 (PLK1) Inhibitor, in combination with abiraterone acetate (Zytiga® – Johnson & Johnson) Read More »

Salix Pharmaceuticals, Ltd., one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases and a wholly owned subsidiary of Valeant Pharmaceuticals International, Inc. have received notice that the U.S. Food and Drug Administration has extended the PDUFA action date for its review of the New Drug Application for PLENVU®* (NER1006) by three months to May 13, 2018. Read More »

Jazz Pharmaceuticals plc announced that the National Comprehensive Cancer Network® (NCCN®) added Vyxeos™ (daunorubicin and cytarabine) liposome for injection to the Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Myeloid Leukemia (AML). Read More »

ArmaGen, Inc., a privately held biotechnology company focused on developing groundbreaking therapies to treat severe neurological disorders, today reported full 52-week results from a Phase 2 proof-of-concept study with AGT-181, the company's investigational therapy for the treatment of mucopolysaccharidosis type I, or MPS I Read More »

Teva Pharmaceutical Industries Ltd. issued the following announcement on Feb. 9.Teva Pharmaceutical Industries Ltd., announced the launch of generic version of Syprine®1 (trientine hydrochloride) capsules, 250 mg, in the U.S. Read More »

Boehringer Ingelheim announced that their Phase II Alzheimer’s disease trials with investigational compound BI 409306 had not met their efficacy endpoints and plans for further trials with BI 409306 in AD will therefore not be pursued. Read More »