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FDA Approves New Indication for Boehringer Ingelheim's Gilotrif in EGFR Mutation-Positive NSCLC biospace
January 17, 2018
Boehringer Ingelheim today announced that the Food and Drug Administration (FDA) has approved the Gilotrif® (afatinib) Supplementary New Drug Application
FDA approves first treatment for breast cancer with a certain inherited genetic mutation biospectrumasia
January 16, 2018
It is the first time any drug has been approved to treat certain patients with metastatic breast cancer who have a "BRCA" gene mutation.
FDA steps in to prohibit codeine cough syrups for children pharmafile
January 15, 2018
The FDA has announced that it will require all labels to state that cough syrups containing codeine or hydrocodone are not suitable for those under the age of 18.
FDA protects children from opioids by revising labelling in prescription cough and cold products europeanpharmaceuticalreview
January 15, 2018
FDA acts to protect children from serious risks of opioid ingredients contained in some prescription cough and cold products by revising labelling to limit paediatrics use…
FDA Panel Rejects Lipocine's Testosterone Pill biospace
January 12, 2018
Lipocine Announces Outcome of FDA Advisory Committee Meeting for TLANDO, Testosterone Replacement Therapy in Adult Males with Hypogonadism
Lupin gets FDA approval expressbpd
January 11, 2018
Lupine announced that it has obtained the final approval of the US Food and Drug Administration (FDA) OELTAMIVIR phosphate capsules USP, 30 mg (base), 45 mg (base) and 75 mg (base)
New project examining FDA-approved drugs for Alzheimer’s, worries over research remains pharmafile
January 11, 2018
It’s been a gloomy period for research into Alzheimer’s disease treatments in the last week, Pfizer announced it would be shuttering its neuroscience division and Axovant’s drug candidate tanked.
FDA Calls Bay Area Global Blood Therapeutics' Sickle Cell Drug a Breakthrough biospace
January 10, 2018
GBT Receives FDA Breakthrough Therapy Designation for Voxelotor for Treatment of Sickle Cell Disease (SCD)
FDA Slaps Breakthrough Tag on Eisai, Merck's Combo Renal Cell Carcinoma Drug biospace
January 10, 2018
Merck and development partner Eisai Co., Ltd. snagged Breakthrough Therapy Designation from the FDA for the combination treatment the companies are developing for the potential treatment of patients with advanced and/or metastatic renal cell carcinoma
FDA clears Amgen's bone drug for multiple myeloma pharmafile
January 09, 2018
Amgen has announced that the FDA has approved the indication expansion of its drug Xgeva to include the treatment of multiple myeloma, adding to its previous indication for the prevention of skeletal-related events in patients with bone metastases from s

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