In an important announcement today (April 2), HUTCHMED and Innovent jointly revealed the acceptance of their New Drug Application (NDA) in China for the combination of Fruquintinib with Sintilimab.
The US Food and Drug Administration (FDA) has approved a topical foam developed by Arcutis Biotherapeutics and branded as Zoryve for the skin condition seborrheic dermatitis in people aged nine years and up.
The oral treatment belzutifan, developed by MSD (known as Merck in the US) and branded as Welireg, has received the green light from the US Food and Drug Administration (FDA) for the treatment of an advanced form of renal cell carcinoma (RCC).
Millions of US adults suffering from heartburn associated with non-erosive-gastroesophageal-reflux-disease (GERD) could benefit from an impending treatment by Phathom Pharmaceuticals.
Astellas Pharma Inc. and Pfizer Inc. today announced that the companies received approval from the US Food and Drug Administration (FDA) for a supplemental New Drug Application for small-molecule drug Xtandi (enzalutamide).
A partnership between clinical research technology company uMotif and cognitive science company, Cogstate Limited, will see the companies continue existing work that includes a major phase 2 clinical trial of a psychedelic therapeutic.
Small molecule drugs are carving a significant niche in lung cancer treatment, according to data and analytics company, GlobalData, and Tagrisso is well on its way to dominating the market.
Chinese biopharmaceutical company, Hutchmed Limited, has announced today (Friday September 29) that it has taken a step towards bringing a colon and rectum cancer drug to a third market.
The first oral pill in the United States specifically for postpartum depression, a serious mental illness, has been approved by the US Food and Drug Administration (FDA).
An experimental antidepressant developed by Neumora Therapeutics has shown promising results in a phase 2 trial, leading the company to plan its pathway to phase 3 testing.
A licensing agreement between Evotec SE and Bristol Myers Squibb Company (BMS) that will ‘bolster a pipeline of programmes targeting several neurodegenerative conditions’ was announced today (July 11).
This year’s CPHI South East Asia is expecting a surge in international partnering with organizers expecting a record attendance of 8,000 visitors including a significant number from overseas – doubling last year’s figures.
Positive phase 3 results from a trial studying fruquintinib, in patients with previously treated colorectal cancer (CRC) were announced by Hutchmed and Takeda on Friday (June 16).
The US Food and Drug Administration (FDA) has announced this month (June) it is requesting feedback on draft recommendations and how they should be applied to increasingly diverse trial types and data sources.
Vedanta Biosciences has obtained fast track designation from the US Food and Drug Administration (FDA) for its live biotherapeutic VE303, a preventative treatment for recurrent Clostridioides difficile infection (CDI).
The naloxone hydrochloride nasal spray will be made available over-the-counter, therefore not requiring a prescription, in an effort to reduce deaths from opioid abuse.
Finding a treatment for a skin disease that significantly diminishes the quality of life for those living with it has moved forward to the next phase of trials.
A powerful tool that could capture abdominal aortic aneurysms (AAA) and refer those at risk is the first to be given clearance by the US Food and Drink Administration (FDA).
Finch Therapeutics announced its shock decision to discontinue the PRISM4 Phase 3 trial of CP101 in recurrent C. difficile infection (CDI) yesterday (Jan 25) saying instead it will focus on ‘realizing the value of its intellectual property estate and...
The Foundation for Sarcoidosis Research hosted more than 50 agency leaders in a session that addressed patient concerns in research, care, and diagnosis.
The company reports it has met the enrollment target for a trial of its sonic beam therapy, one step closer to submitting for FDA approval of the product.
This year’s DIA Global Annual Meeting (taking place June 19-23 in Chicago) reunites professionals for face-to-face learning and networking opportunities.
Efanesoctocog alfa is an investigational factor III therapy designed to prevent bleeds and bleeding episodes in patients diagnosed with the rare disorder.
The approval is the first that the Food and Drug Administration has granted for a drug intended to treat eosinophilic esophagitis, a chronic immune disorder.
The agency has removed the hold placed on the pharmaceutical company’s IND for injectable lenacapavir, which is intended for HIV treatment and prevention.
An expert from the organization discusses ahead of his CPhI North America presentation how tomorrow’s drugs can’t all be formulated with yesterday’s excipients.
CPhI North America 2022 host city Philadelphia is set to become one of the world’s biggest cell and gene therapy manufacturing hubs. But it’s just one of many centers of innovation that are helping drive the US pharma and biopharma industry.
The agency has approved an expanded indication for Qelbree extended-release capsules to treat attention deficit hyperactivity disorder in younger patients.
The US agency has expanded its approval of Veklury to include use in pediatric patients 28 days and older who have tested positive for the COVID-19 virus.
The US Food and Drug Administration has approved a move to make the oral lead-in period for ViiV Healthcare’s once-every-other-month drug Cabenuva optional.
The US agency’s latest draft document lays out guidelines to help increase involvement of underrepresented ethnic and racial populations in clinical research.
The Australian biotechnology company has been granted ODD status from the agency for Veyonda, a therapy intended for the treatment of soft-tissue sarcoma.
The agency's requested funding for FY 2023, nearly 34% higher than for FY 2022, calls for investments in public health modernization and pandemic preparation.
The drug has received the agency’s seal of approval to treat seizures associated with difficult-to-treat seizures associated with Lennox-Gastaut syndrome.
Windlas issued a warning letter by the US FDA after the regulator finds the manufacturer’s response inadequate to justify wrongdoings at its India facility.
Aiming to encourage entry of generic drugs on the market, the US FDA published a finalized guidance that regulates processes for relevant designations and expedited approvals.
Spaulding has been contracted by the US FDA to support clinical trials in various therapeutic areas for the following five years, starting with a $5m reward for the first year.
The US FDA announces shortage of a drug due to a site affected by coronavirus, as it focuses on the protection of the supply chain from outbreak impacts.
