Highlights
Kyowa Kirin Announces FDA Acceptance of Istradefylline (KW-6002) New Drug Application Resu
TOKYO--(BUSINESS WIRE)--Apr 4, 2019--Kyowa Hakko Kirin Co., Ltd. (TOKYO:4151, President and CEO: Masashi Miyamoto, &ldqu
FDA Approves Ibrance (palbociclib) for the Treatment of Men with HR+, HER2- Metastatic Bre
April 4, 2019 -- Pfizer (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) approved a supplemen
EMA accepts Takeda application for subcutaneous Entyvio
The company proposes to make it available in both pre-filled syringe and pen options.
E-cigarette: Safety Communication - Related to Seizures Reported Following E-cigarette Use
Audience: Consumers, Emergency Medicine, Health Professionals ISSUE: The FDA has become aware that some people who use e
Evoke Pharma Receives Complete Response Letter and Recommendations to Address Deficiencies
SOLANA BEACH, Calif., April 02, 2019 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical c
Antidepressants in the treatment of major depression: a changing landscape for clinical de
With publication of the update to the National Institute of Health and Care Excellence depression guideline postponed
FDA to Modernize 510(k) Clearance Pathway
nl The Food and Drug Administration is changing the most common way it approves new low- to moderate-risk medic
Regulatory Reporting: What can Medical Device Manufacturers Learn from Big Pharma?
Pharmaceutical companies have long been subject to the kinds of rigorous electronic reporting standards that will soo
FDA Approves Avaclyr (acyclovir ophthalmic ointment) for the Treatment of Herpetic Keratit
NEW YORK–(BUSINESS WIRE) April 01, 2019 –The US Food and Drug Administration (FDA) has approved Fera Pharmac
After Scoring New Capital, Fifth Eye Prepares to Seek FDA Approval
Fifth Eye, an Ann Arbor-based medical software startup spun out of technology developed at the University of Michigan, t
MHRA Issues Guidance for Air Shipping Medicines in No-Deal Brexit
nl The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released guidance for EU drugmake
Another EtO Medical Device Sterilizer to Close Due to Environmental Quality Issues
Viant Medical’s Grand Rapids, MI facility was hit with violations from the Michigan Department of Environmenta