PFIZER: U.S. FDA Approves LORBRENA® (lorlatinib) for Previously-Treated ALK-Positive Metastatic NSCLC
LORBRENA Addresses Unmet Needs for Certain Patients Treated With Prior ALK Therapy Read More »
ACELRX PHARMACEUTICALS, INC.: Announces FDA approval of DSUVIA™
AcelRx Pharmaceuticals, Inc. (AcelRx) (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in a medically supervised setting, announced the approval of DSUVIA™ by the U.S. Food and Drug Administration (FDA). Read More »
THERAVANCE BIOPHARMA: Announces Sale of VIBATIV® (telavancin) to Cumberland Pharmaceuticals
Theravance Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma" or the "Company") announced the sale of its proprietary antibiotic, VIBATIV® (telavancin), to Cumberland Pharmaceuticals, Inc. Read More »
SANOFI: FDA grants priority review for Dupixent® (dupilumab) as potential treatment for adolescents with uncontrolled moderate-to-severe atopic dermatitis
The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) in adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis, whose disease was inadequately controlled with topical therapies or for whom topical treatment was medically inadvisable. Read More »
ARIXA PHARMACEUTICALS: Announces Publication of Seminal Paper Demonstrating First Oral Prodrug of Avibactam
Arixa Pharmaceuticals issued the following announcement on Nov. 12.Arixa Pharmaceuticals™, Inc., a company dedicated to developing oral antibiotics for drug-resistant Gram-negative infections, today announced publication of a paper describing the chemistry of its oral prodrug of avibactam, a previously intravenous (IV)-only beta lactamase inhibitor (BLI). Read More »
CERTARA: US FDA Awards Certara’s Simcyp Division Two New Dermal Virtual Bioequivalence Grants
New grants support FDA’s GDUFA priorities of expanding bioequivalence methods for topical dermatological products and improving PBPK models of drug absorption via complex delivery routes Read More »
U.S. FOOD AND DRUG ADMINISTRATION: FDA approves new drug to treat travelers’ diarrhea
The U.S. Food and Drug Administration approved Aemcolo (rifamycin), an antibacterial drug indicated for the treatment of adult patients with travelers’ diarrhea caused by noninvasive strains of Escherichia coli (E. coli), not complicated by fever or blood in the stool. Read More »
AQUESTIVE THERAPEUTICS: Receives Complete Response Letter from U.S. Food and Drug Administration (FDA) for Tadalafil Oral Film
.jpg){kind=tracking}
Aquestive Therapeutics, Inc. (NASDAQ: AQST) announced it received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) in regards to its New Drug Application (NDA) for tadalafil oral film (OF). Read More »
MYLAN N.V.: Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP
Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient Read More »
DAIICHI SANKYO, INC.: FDA Grants Priority Review for Daiichi Sankyo's New Drug Application for FLT3 Inhibitor Quizartinib for Treatment of Patients with Relapsed/Refractory FLT3-ITD AML
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) and granted Priority Review for quizartinib for the treatment of adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML). Read More »
Alerts Sign-up