TARRYTOWN, N.Y. , Aug. 20, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has extended the target action dates to the fourth quarter of 2025 for two EYLEA HD® (aflibercept) Injection 8 mg regulatory submissions. This includes a Chemistry, Manufacturing and Controls (CMC) Prior-Approval Supplement (PAS) for the EYLEA HD prefilled syringe and a supplemental Biologics License Application (sBLA) seeking approva

CAD $79 million term loan replaces USD $56 million term loan CAD $107 million (~USD $77.5 million) total facility provides enhanced financial flexibility CAD-denominated facility reduces FX exposure and lowers interest rate TORONTO, Aug. 20, 2025 /CNW/ - HLS Therapeutics Inc. ("HLS" or the "Company") (TSX: HLS), a pharmaceutical company focusing on addressing unmet needs in the treatment of psychiatric disorders and cardiovascular disease, announces that the company has entered into a new Credit

The US Food and Drug Administration (FDA) has rejected PTC Therapeutics ’ new drug application (NDA) for vatiquinone in Friedreich’s Ataxia . This follows the biotech’s decision to submit the 15-lipoxygenase (15-LO) inhibitor for approval in the indication, despite it failing to meet its primary endpoint in the Phase III MOVE-FA trial (NCT04577352). PTC Therapeutics’ vatiquinone for Friedrich ataxia has been rejected by the FDA. Image credit: Piotr Swat / ShutterStock.com. Hedging its bets, PTC

– U.S. Food and Drug Administration accepts sNDA for filing with priority review; sets PDUFA goal date of December 20, 2025 -- – European Medicines Agency accepts and validates submission for Type II variation MAA for setmelanotide to treat acquired hypothalamic obesity – – Company to host “Commercial Readiness for Acquired Hypothalamic Obesity,” event for investors and analysts on Wednesday, September 24, in Boston – BOSTON, Aug. 20, 2025 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq

iStock, Mst Khotaja Begum Capricor Therapeutics met with the FDA last week for a type A meeting, during which CEO Linda Marbán aimed to explain to the regulator that it got it wrong. Capricor plans to resubmit the application based on deramiocel’s existing dataset. After being hit last month with a complete response letter for its investigational cell therapy deramiocel, which it is developing for cardiomyopathy associated with Duchenne muscular dystrophy, Capricor Therapeutics will resubmit.

Wikimedia /White House The Trump administration’s ever-changing tariffs and Most Favored Nation drug pricing are part of a blizzard of unclear, potentially illegal tactics that leave observers throwing their hands in the air. Never before has the pharmaceutical industry had to consider international trade agreements in its daily business. The matter was settled in 1994, until Donald Trump returned to the White House with a blizzard of confusing policy proposals, from tariffs to Most Favored Nat

The US Food and Drug Administration (FDA) has granted accelerated approval to Jazz Pharmaceuticals’ Modeyso (dordaviprone) as the first treatment for an ultra-rare and aggressive brain tumour that primarily affects children and young adults. The drug has been approved to treat adult and paediatric patients aged one year and older with diffuse midline glioma harbouring an H3 K27M mutation who have progressive disease following prior therapy. The disease, which progresses rapidly and historically

Revenue and earnings for Gubra Group have been record-high in the second quarter of 2025 driven by the outlicensing deal with AbbVie in our Discovery & Partnerships business. While the CRO business also experienced revenue growth in the second quarter of 12% year-over-year, the full-year outlook for CRO revenue in 2025 has been revised to be slightly below CRO revenue level in 2024 (previous outlook 10-20% revenue growth). Outlook for EBIT-margin in the CRO business has been revised to around 20

iStock, pilli Regulations aiming to lower the cost of vital medicines will instead end up restricting access and disincentivizing R&D. In May of this year, President Donald Trump signed an executive order aiming to bring U.S. drug prices in line with those in countries where medicines are cheaper, and followed this with letters to biopharmaceutical CEOs in July outlining requests along the same lines. Meanwhile, to date, 25 drugs have been selected for Medicare price controls as directed by

iStock, hapabapa The FDA recommends that companies use overall survival as a primary endpoint for clinical trials where feasible. The new guidance follows the surprising return of CBER Head Vinay Prasad, who has previously argued for prioritizing OS. The FDA wants to put a stronger emphasis on overall survival outcomes for the investigational cancer therapies it reviews, a move that could make it harder—but not impossible—for companies to seek accelerated approval for their products. The new r