Takeda and HUTCHMED's Fruquintinib NDA for Metastatic Colorectal Cancer Gets Priority Review

— Prescription Drug User Fee Act (PDUFA) Target Action Date set for November 30, 2023 — — NDA includes results from the Phase III FRESCO...

May 26, 2023 | Friday | News
Indivior Receives FDA Approval for OPVEE® Nasal Spray, Opioid Overdose Rescue Medicine

In the 12-month period ending in December 2022, over 79,000 people in the U.S. were reported to have died of an opioid overdose, of whi...

May 23, 2023 | Tuesday | News
Alliance Pharma and Drug Development Solutions Are Now Resolian

“Resolian merges expertise from Alliance Pharma and Drug Development Solutions — two leading providers of bioanalysis and analytical sciences &...

May 19, 2023 | Friday | News
Everest Medicines Completes Patient Enrollment in Phase 3 Trial of Etrasimod in Asia

"We are very pleased to achieve full patient enrollment in Asia ahead of schedule, which brings Everest an important step closer to offering etrasimod to p...

May 17, 2023 | Wednesday | News
FDA Approves Novel Drug to Treat Moderate to Severe Hot Flashes Caused by Menopause

"Hot flashes as a result of menopause can be a serious physical burden on women and impact their quality of life," said Janet Maynard, M.D., M.H.S., direct...

May 15, 2023 | Monday | News
MediciNova granted new patent for MN-166 (ibudilast) in Europe for microorganism infection

Once issued, the patent maturing from this allowed patent application is expected to expire no earlier than February 2039. The allowed claims cover MN...

May 15, 2023 | Monday | News
Veeva Partners with Sanofi to Transform its Quality System

Veeva Systems (NYSE: VEEV) today announced that Sanofi is implementing Veeva Vault QMS and Veeva Vault QualityDocs to modernize quality management across t...

May 11, 2023 | Thursday | News
China NMPA Approves TYVYT® Combo for EGFR-mutated NSCLC Patients Who Progressed After EGFR-TKI Therapy

This is the seventh NMPA-approved indication of TYVYT® (sintilimab injection). The first six indications of TYVYT® (sintilimab injection) are inclu...

May 10, 2023 | Wednesday | News
BeiGene Receives New Approvals for BRUKINSA® (zanubrutinib) in China

BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced the China National Medical Products Administration (NMPA)...

May 08, 2023 | Monday | News
Junshi Biosciences and Dr. Reddy's Partner to Develop Toripalimab in 21 Countries.

“We are thrilled to have established a partnership with Dr. Reddy’s while toripalimab’s global commercial network has been steadily expan...

May 08, 2023 | Monday | News
Amphista Therapeutics Achieves First Discovery Milestone in Collaboration with Bristol Myers Squibb

Nicola Thompson, CEO of Amphista, said, "We are absolutely delighted with the progress and success of our collaboration with BMS. Our ability to deliver ou...

May 05, 2023 | Friday | News
Moderna and Merck's Neoantigen Therapy, mRNA-4157, Shows Superior Survival in High-Risk Stage III/IV Melanoma Patients Compared to KEYTRUDA

mRNA-4157 (V940) in combination with KEYTRUDA reduced the risk of recurrence or death by 44% compared to KEYTRUDA alone in stage III/IV melanoma patients...

May 04, 2023 | Thursday | News
Akorn Recalls Expired Human and Animal Drugs Nationwide Due to Shutdown

Akorn Operating Company LLC has filed Chapter 7 bankruptcy on February 23, 2023. In connection with that filing, the company has ceased and shutdow...

May 04, 2023 | Thursday | Regulatory
PharmAla Biotech to form Australian Psychedelics Joint Venture with Vitura Health

PharmAla Biotech Holdings Inc. (“PharmAla”)(CSE: MDMA) is pleased to announce the establishment of a 50:50 joint venture, "Cortexa", with Austr...

May 02, 2023 | Tuesday | News

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