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The Latest Breaking News from Astellas

FDA Expands Keytruda Approval to All Bladder Cancer Patients Before Surgery, Not Just Those Avoiding Chemo

The FDA expanded Keytruda plus Padcev to all muscle-invasive bladder cancer patients on July 10, 2026. Here is who now qualifies and what the KEYNOTE-B15 trial showed.

Medical Daily

AbCellera Biologics Bets on Hot Flash Antibody as Pipeline Pivot Gains Steam

AbCellera Biologics (NASDAQ:ABCL) is emphasizing its transition from a partner-based antibody discovery business to a proprietary drug development company, Chief Financial Officer Andrew Booth said during a company presentation focused on the biotech’s pipeline and lead clinical program. Booth said

MarketBeat

Scotland first part of UK to approve ‘cutting edge’ treatment for stomach cancer

The Scottish Medicines Consortium has approved zolbetuximab – to be used together with chemotherapy – to treat those with advanced stomach cancer.

Evening Standard

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Testosterone levels decline with age, not menopause, despite what you’ve heard

Social media widely promotes testosterone as an essential part of menopausal hormone therapy (MHT, also known as hormone replacement therapy or HRT) to treat low mood, brain fog and loss of vitality.

The Conversation

Why Is Taysha Gene Therapies Stock Falling Friday?

Taysha Gene Therapies, Inc. (NASDAQ:TSHA) stock is trading lower on Friday, with a session volume of 4.695 million, as per data from Benzinga Pro.

Benzinga

Pfizer, Astellas Report Xtandi Survival Win In Prostate Cancer Study

Pfizer Inc. (NYSE:PFE) and Astellas Pharma Inc. (OTC:ALPMF) (OTC:ALPMY) on Thursday released topline results from the overall survival (OS) analysis from the Phase 3 EMBARK study evaluating Xtandi (enzalutamide), in combination with leuprolide and as a monotherapy, in men with non-metastatic hormone-sensitive prostate cancer with biochemical recurrence (BCR) at high…

Benzinga

Pharma Giant Warns Pills Critical For Organ Transplant Patients' to Survive May Be Completely Empty in Urgent Recall

Pharmaceutical company Astellas Pharma announced two urgent recalls for vital immunosuppressive drugs, Prograf and Astagraf XL, that are used to prevent organ rejection in transplant recipients.

International Business Times

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Breakthrough Treatment Veoza Receives UK Approval to Tackle Hot Flushes

Veoza distinguishes itself as a non-hormonal menopause drug that directly targets the brain to prevent hot flushes.

International Business Times UK

A 'game-changing' new drug for hot flushes has just been approved: what does this mean for UK women?

Veoza is the new drug for hot flushes that's been approved for use in the UK with immediate effect

Woman & Home

New menopause drug to treat hot flushes given green light in UK

Women can be prescribed Veoza from January after facing decades with few treatment options

The Independent UK

‘Gamechanging’ drug to prevent hot flushes wins approval in UK

Veoza, also known as fezolinetant, is prescription-only and will be available privately from January

The Guardian - UK

3 Stocks With MAJOR Growth Potential

Considering the recent robust economic indicators and growing optimism, I think fundamentally strong growth stocks América Móvil (AMX), Astellas Pharma (ALPMY), and Bruker (BRKR) could be ideal investments. Continue reading.

StockNews.com

New menopause drug for hot flashes gets FDA approval

The Food and Drug Administration has approved a new type of drug to treat hot flashes caused by menopause

The Independent UK

Japan foreign minister Hayashi to visit Beijing on Saturday

Japan Foreign Minister Yoshimasa Hayashi said on Friday he will visit Beijing for two days from Saturday to discuss a range of issues, including the detention of an Astellas Pharma Inc employee.

Reuters

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Los Angeles Times

Michael Hiltzik: Biden says he wants to bring down drug prices. His actions tell a different story

You might get the impression from the Biden administration's insulin price cut and its initiative allowing Medicare to negotiate over other pharmaceuticals that the drug pricing issue is finally being taken seriously in Washington.

Benzinga

Sutro Biopharma Stock Surges On Cancer Treatment Pact

Astellas Pharma Inc (OTC: ALPMF) and Sutro Biopharma Inc (NASDAQ:STRO) announced a strategic collaboration and licensing agreement focused on the discovery and development of immunostimulatory antibody-drug conjugates (iADC). iADCs are a next-generation modality for treating cancer and are designed to boost anti-cancer activity. They offer potential new options for patients who do not respond to existing…

Benzinga

The Daily Biotech Pulse: CHMP Backs AstraZeneca's Breast Cancer Therapies, Ipsen Buys Epizyme, FDA Holds For Nuvation Bio, Astellas Studies

Here's a roundup of top developments in the biotech space over the last 24 hours:

Benzinga

Astellas's Pompe Disease Gene Therapy Trial Put On FDA Clinical Hold

The FDA has placed a clinical hold on Astellas Pharma Inc's (OTC:ALPMY) FORTIS Phase 1/2 trial following a serious adverse event (SAE) of peripheral sensory neuropathy in one of the trial participants. FORTIS trial is evaluating AT845, an investigational adeno-associated virus (AAV) gene replacement therapy in adults with Late-Onset Pompe Disease. The FDA has…

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Benzinga

Twist Bioscience, Astellas Join Forces To Develop Cancer Targeting Antibodies

Twist Bioscience Corporation (NASDAQ:TWST) has entered into a research collaboration and exclusive option license agreement with Astellas Pharma Inc (OTC:ALPMF) to conduct research activities to identify and optimize proprietary Twist antagonist antibodies. The antibodies will target an undisclosed checkpoint inhibitor pathway in the tumor microenvironment as potential therapeutic development candidates. Ligands in this pathway are…

Benzinga

Astellas' Menopause Drug Suffers Setback After Failed Asian Trial

After acing a pair of phase 3 trials, Astellas Pharma Inc (OTC:ALPMF) has reported the failure of fezolinetant to beat placebo in a late-stage study of patients in Asia. The study randomized 302 women in China, Korea, and Taiwan. After 12 weeks, Astellas saw numerical improvements in the rate of hot flashes from baseline…

Benzinga

Astellas Touts Safety Data For Phase 3 Menopause Drug, Sets Up US Filing

Astellas Pharma Inc (OTC:ALPMF) announced topline results from the Phase 3 SKYLIGHT 4 trial investigating the long-term safety of fezolinetant in vasomotor symptoms associated with menopause (VMS). The data will support future regulatory filing submissions. The study has met its primary objectives, including safety and tolerability and improvements in endometrial health at week…

Los Angeles Times

Michael Hiltzik: The government could force a price cut for this prostate cancer drug by as much as 80%. Why hasn't it acted?

Xtandi, a wonder drug for prostate cancer, was developed at UCLA with substantial funding from the taxpayers through the Pentagon and the National Institutes of Health.

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